[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-multiple-myeloma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,43,66,87,110,139,162,185,208,229,248,270,291,310,331,353,371,392,413,434,455,473,498,518,539],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100533916","phase-1-testing-the-combination-of-two-approved-drugs-and-one-experimental-drug-in-patients-with-relapsed-or-refractory-multiple-myeloma-100533916",false,"NCT06232044","Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma","A Phase I\u002FII Study of the Safety, Tolerability and Efficacy of Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)\u002FDexamethasone Versus Belantamab Mafodotin (GSK2857916)\u002FDexamethasone in Relapsed Refractory Multiple Myeloma","* Documentation of disease: Diagnosis of multiple myeloma and have relapsed or refractory disease according to the IMWG criteria where:\n\n  * Progression of myeloma is defined by IMWG criteria as recurrence of disease after prior response, indicated as any of the following:\n\n    * ≥ 25% increase in M-protein (must be at least 0.5g\u002Fdl above nadir from last treatment regimen).\n    * 25% difference between involved and uninvolved serum free light chains from its nadir or\n    * The development of new plasmacytomas or hypercalcemia.\n  * Refractory myeloma as defined by IMWG criteria as disease which become non-responsive or progresses on therapy or within 60 days of last treatment in patients who had achieved a minimal response or better on prior therapy.\n* Measurable disease defined by IMWG criteria as:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL.\n  * Urine monoclonal protein ≥ 200 mg\u002F24h.\n  * Serum free light chains (FLC) assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) and serum free light chain ratio is abnormal.\n* Two or more prior lines of therapies, triple-class exposed (exposed \u002Frefractory to an immunodulatory derivative (IMiD) and\u002For proteasome inhibitors (PI) and\u002For to daratumumab or other anti-CD38 monoclonal antibody).\n* No prior exposure to iberdomide or belamaf.\n* No prior BCMA-directed therapy.\n* No prior treatment with a monoclonal antibody within 2 weeks of registration.\n* No history of severe allergic reaction (including erythema nodosum) to lenalidomide, pomalidoimide or other prior IMiD therapy.\n* No prior allogeneic stem cell transplant. NOTE: Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active GvHD.\n* Participant must not have received a live or live-attenuated vaccine within 30 days prior to registration.\n* No plasmapheresis within 7 days prior to registration.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3.\n* Platelet count ≥ 75,000\u002Fmm\\^3 (or ≥ 50,000\u002Fmm\\^3 in Phase II if bone marrow (BM) plasma cells \\> 50%).\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Spot urine (albumin\u002Fcreatinine ratios) \\\u003C 500 mg\u002Fg (56 mg\u002Fmmol) OR urine dipstick ≥ 1+ if confirmed.\n* Total bilirubin ≤ 2 mg\u002FdL.\n* Aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN).\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown. FCBP (female of childbearing potential) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months). Women of childbearing potential (WOCBP):\n\n  * Must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), preferably with low user dependency during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n  * The effects of iberdomide on the developing human fetus are unknown. Immunodulatory derivative (IMiD) agents as well as other therapeutic agents used in this trial are known to be teratogenic. Females of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to, and again within 24 hours of starting iberdomide, and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking iberdomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure.\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. FCBP must use adequate contraception for at least 4 months after discontinuation from study. Because of the potential for serious adverse reactions in a breastfed child, women are advised not to breastfeed during treatment and for at least 3 months after the last dose.\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons):\n  * ≥ 45 years of age and has not had menses for \\> 1 year\n  * Patients who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n  * Male patients must agree to use an adequate method of contraception for the duration of the study and for 6 months afterwards.\n  * Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies: Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:\n  * Refrain from donating sperm PLUS, either:\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR\n  * Must agree to use contraception\u002Fbarrier as detailed below:\n  * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n* Archival tissue must be available for submission for the mandatory correlative studies.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n  \\* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.\n* No patients with uncontrolled human immunodeficiency virus (HIV), hepatitis C and B. Testing for HIV and hepatitis C and B are not required prior to registration.\n\n  \\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* No positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to registration unless the participant can meet the following criteria:\n\n  * RNA test negative.\n  * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks.\n* Patients with hepatitis B will be excluded unless the following criteria can be met.\n\n  * Serology: Hepatitis B core antibody positive (HbcAb)+, hepatitis B surface antigen (HbsAg)-.\n  * Screening: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) undetectable.\n  * During study treatment: Monitoring per protocol.\n  * During study treatment: Antiviral treatment instituted if HBV DNA becomes detectable.\n  * Serology: HBsAg+ at screen or within 3 months prior to registration.\n  * Screening: HBV DNA undetectable.\n  * Screening: Highly effective antiviral treatment started at least 4 weeks prior to first registration.\n  * Screening: Baseline imaging per protocol.\n  * Screening: Participants with cirrhosis are excluded.\n  * During study treatment: Antiviral treatment maintained throughout study treatment.\n  * During study treatment: Monitoring and management per protocol. \\*\\* Note: Presence of isolated hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.\n* No patients with unacceptable cardiac risk factors defined by any of the following criteria:\n\n  * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n  * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.\n  * Class III or IV heart failure as defined by the New York Heart Association functional classification system \\[Error! Reference source not found., 1994\\].\n  * Uncontrolled hypertension.\n  * Patients with congenital long QT syndrome, QTcF interval QTcF \\> 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula \\[QTcF\\]).\n  * Any history of ventricular fibrillation or torsade de pointes.\n  * Symptomatic bradycardia defined as heart rate (HR) \\\u003C 50 bpm with associated dizziness\u002Fsyncope.\n  * Left ventricular ejection fraction \\\u003C 30%.\n* No patients who have received targeted (non-monoclonal antibodies \\[mAb\\]) or investigational agents within 2 weeks prior to rgistration and who have not recovered from side effects of those therapies.\n* No patients who have undergone major surgery ≤ 2 weeks prior to registration or who have not recovered from the side-effects of surgery.\n* No known medical condition causing an inability to swallow oral formulations of agents.\n* No active bacterial, viral or fungal infection (s) present.\n* Patients cannot have a Child-Pugh score greater than 1 (absent ascites, total bilirubin \\\u003C 2, international normalized ratio (INR) \\\u003C1.7 (unless on anticoagulation), and no encephalopathy; esophageal or gastric varices, and cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.\n* No presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill inclusion criteria.\n* No evidence of active mucosal or internal bleeding.\n* No known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belamaf or drugs chemically related to belamaf, or any of the components of the study treatment.\n* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium. For belantamab mafodotin, concomitant administration with strong inhibitors of OATP should be avoided.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Patients must meet criteria for progression of myeloma as defined by IMWG criteria indicated as any of the following:\n\n  * ≥ 25% increase in M-protein (must be at least 0.5 g\u002Fdl above nadir from last treatment regimen).\n  * 25% difference between involved and uninvolved serum free light chains from its nadir or\n  * The development of new plasmacytomas or hypercalcemia not due to other causes. In the absence of progression by serum M protein or free light chain, biopsy of new plasmacytoma of extramedullary disease is warranted.\n  * If refractory myeloma, it should be defined by IMWG criteria as disease which has become non-responsive or progressive on belamaf\u002Fdexamethasone.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Measurable disease defined by IMWG criteria as:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL.\n  * Urine monoclonal protein ≥ 200 mg\u002F24h.\n  * Serum FLC assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) and serum free light chain ratio is abnormal.\n  * PET\u002FCT or MRI findings consistent with (c\u002Fw) disease progression.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Platelet Count ≥ 75,000\u002Fmm\\^3 (or ≥ 50,000\u002Fmm\\^3 if BM plasma cells \\> 50%).\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Calc. creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Total bilirubin ≤ 2 mg\u002FdL.\n* RE-REGISTRATION ELIGIBILITY CRITERIA: AST\u002FALT ≤ 2.5 x upper limit of normal (ULN).\n* RE-REGISTRATION ELIGIBILITY CRITERIA: Alkaline phosphatase ≤ 3 x ULN.","ALL","18 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.",[28,29],"Recurrent Multiple Myeloma","Refractory Multiple Myeloma","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2025-04-23",{"date":38,"type":21},"2030-08-01",{"name":40,"class":41},"Alliance for Clinical Trials in Oncology","OTHER",42,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100551840","phase-1-testing-teclistamab-tecvayli-in-combination-with-iberdomide-for-relapsed-or-refractory-multiple-myeloma-100551840","NCT06465316","Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma","A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed multiple myeloma (MM), as defined in the International Myeloma Working Group (IMWG) criteria\n* If patients have undergone autologous stem cell transplant (SCT), day 0 of SCT must be \\> 100 days to be eligible for the study\n* Patients must have had disease progression after ≥ 4 prior lines of anti-myeloma treatments including one proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), one immunomodulatory imide drug (ImiD) (e.g., thalidomide, lenalidomide, pomalidomide \\[POM\\]), and one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)\n* Patients must have measurable disease, defined as:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL (≥ 5 g\u002FL)\n  * Urine M-protein ≥ 200 mg\u002F24 h\n  * Serum free light chain (FLC) assay: \"involved\" FLC level ≥ 10 mg\u002FdL (≥ 100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C 0.26 or \\> 1.65)\n  * Note: Patients with non-secretory disease will be allowed to participate\n* Age ≥ 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of iberdomide in combination with teclistamab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60)\n* Hemoglobin ≥ 7.0 g\u002FdL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)\n* Absolute neutrophil count ≥ 1,000\u002FmcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)\n* Platelets ≥ 50,000\u002FmcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (≤ 28 days prior to registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (≤ 28 days prior to registration)\n* Estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin (≤ 28 days prior to registration)\n* Spot urine (albumin\u002Fcreatine ratio) ≤ 500mg\u002Fg (56 mg\u002Fmmol) OR urine dipstick negative\u002Ftrace (if \\> 1+ only eligible if confirmed ≤ 500 mg\u002Fg (56 mg\u002Fmmol) by albumin\u002Fcreatinine ratio (spot urine from first void) (≤ 28 days prior to registration)\n* Note: Laboratory results obtained during screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the subject and the subsequent within range screening result may be used to confirm eligibility\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging done a minimum of 28 days after completion of central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on the mechanism of action, teclistamab may cause fetal harm when administered to a pregnant woman. Females of child-bearing potential (FCBP): should use effective contraception during treatment with teclistamab and for 5 months after the last dose. FCBP should not breast feed during treatment with teclistamab and for 5 months after the last dose. Should a FCBP become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The effects of iberdomide on the developing human fetus are unknown. However, IMiDs are known to be teratogenic. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days prior to starting iberdomide, and again within 24 hours. FCBP must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control-one highly effective method and one additional effective method-at the same time, at least 28 days before starting iberdomide, while taking iberdomide, and for 28 days following discontinuation from the study. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with FCBP while participating in the study, during dose interruptions, and for at least 28 days following discontinuation from the study, even if he has undergone a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure\n* Men must agree to abstain from donating and semen or sperm while taking iberdomide, during dose interruptions, and for at least 28 days after the last dose of iberdomide. FCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period\n* All patients must agree to abstain from donating blood products while taking iberdomide and for at least 28 days after the last dose of iberdomide\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study subjects\n* Willingness to adhere to the study visit schedule and other protocol requirements and provide mandatory blood and bone marrow specimens for correlative research\n* Willingness to return to the enrolling institution for follow-up\n\nExclusion Criteria:\n\n* Patients who have active plasma cell leukemia, active amyloid light chain (AL) (primary) amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, myeloma protein, and skin changes), and Waldenstrom macroglobulinemia are ineligible\n* If a patient develops recurrent\u002Frefractory (R\u002FR) disease while receiving the most recent line of therapy, there is no need for a washout period\n* Patients who have had prior anti-BCMA directed bispecific antibody (BsAb) therapy exposure (prior treatment with anti-BCMA directed antibody drug conjugate, anti-BCMA-directed chimeric antigen receptor (CAR) T cell therapy, and prior non-BCMA-targeting BsAb are permitted)\n* Patients who have had prior treatment with a cereblon E3 ligase modulator, including mezigdomide, iberdomide, and CFT7455 (all currently in clinical development)\n* Patients who received plasmapheresis ≤ 7 days prior to registration\n* Patients who received a prior allogeneic SCT. Autologous SCT is allowed\n* Patients who received a live or live-attenuated vaccine ≤ 30 days prior to registration. Patients are allowed to receive a coronavirus disease 2019 (COVID-19) vaccine at any timepoint during protocol treatment\n* Systemic active infection requiring treatment\n* Any unresolved toxicity ≥ grade 2 from previous treatment except for alopecia or peripheral neuropathy up to grade 2\n* Patients who have had any major surgery ≤ 4 weeks prior to registration\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patients with evidence of active mucosal or internal bleeding\n* Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria\n* Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or iberdomide, or any of the components of the study treatment\n* Patients who are taking any anticancer therapy other than hormonal therapy (for prostrate or breast cancer) and palliative radiotherapy (defined as radiation to ≤ 3 sites of active multiple myeloma)\n* Patients who require immunosuppressive medications including, but not limited to, systemic corticosteroids at doses exceeding 10 mg\u002Fday of prednisone or equivalent. Use of immunosuppressive medications for the management of iberdomide-related adverse events (AEs) or in subjects with contrast allergies is acceptable. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (e.g., intra-articular injection) is permitted. Temporary use of corticosteroids for concurrent illnesses (e.g., food allergies, computed tomography \\[CT\\] scan contrast hypersensitivity, pneumonia, etc.) are acceptable\n* Patients who require medications that are strong inhibitors or inducers of CYP3A4\u002F5\n* Patients who are receiving any other investigational agents\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because iberdomide is a thalidomide analog and thalidomide is a known human teratogen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iberdomide, breastfeeding should be discontinued if the mother is treated with iberdomide. These potential risks may also apply to other agents used in this study\n* Patients who are unable or unwilling to undergo protocol required thromboembolism prophylaxis are excluded",{"count":51,"type":21},26,[24],"This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving iberdomide in combination with teclistamab may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma.",[28,29],"2026-06-27",{"date":57,"type":34},"2026-06-30",{"date":59,"type":34},"2024-12-06",{"date":61,"type":21},"2026-12-31",{"name":63,"class":64},"National Cancer Institute (NCI)","NIH",14,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100628605","phase-1-testing-the-investigational-medication-combination-of-teclistamab-and-pomalidomide-compared-to-the-usual-treatment-carfilzomib-pomalidomide-and-dexamethasone-for-patients-with-multiple-myeloma-who-have-relapsed-shortly-after-treatment-100628605","NCT07463807","Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment","Phase Ib\u002FII Fixed Duration Study of Teclistamab\u002FPomalidomide (TP) Versus Carfilzomib\u002FPomalidomide\u002FDexamethasone (KPd) in Early Relapse of Multiple Myeloma","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay for Phase II only\n* Patient must have multiple myeloma and meet both of the following criteria for the original diagnosis of myeloma following the International Myeloma Working Group (IMWG) myeloma diagnostic criteria:\n\n  * Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.\n\n    * Tissue biopsy of any bone lesion or extramedullary plasmacytoma if applicable (positive\u002Fnegative for clonal plasma cells)\n  * Any one or more of the following symptomatic myeloma-defining events that prompted initiation of therapy as well as end-organ damage:\n\n    * Anemia (hemoglobin value of \\> 2 g\u002FdL below the lower limit of normal, or a hemoglobin value \\\u003C 10 g\u002FdL)\n    * Hypercalcemia (serum calcium \\> 1 mg\u002FdL higher than the upper limit of normal or \\> 11 mg\u002FdL)\n    * Bone disease (one or more osteolytic lesions on skeletal radiography, CT, or FDG-PET\u002FCT)\n    * Renal dysfunction (creatinine clearance \\\u003C 40 mL\u002Fmin or serum creatinine \\> 2 mg\u002FdL).\n    * Clonal bone marrow plasma cells (BMPCs) ≥ 60%\n    * Involved\u002Funinvolved serum free light chain ratio ≥ 100\n    * \\> 1 focal lesions on magnetic resonance imaging (MRI) studies ≥ 5 mm\n  * NOTE: Patients with smoldering myeloma (serum m protein ≥ 3 gm\u002FdL or bone marrow plasma cells ≥ 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein \\\u003C 3 gm\u002FdL and bone marrow plasma cells \\\u003C 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible\n* Patient must have experienced early relapse disease defined as relapse after one line of lenalidomide therapy including single agent lenalidomide or lenalidomide\u002Fdexamethasone or CD38 antibody\u002Flenalidomide +\u002F- dexamethasone. The relapse can be progressive disease as determined by the treating clinician and meeting measurable disease criteria\n* Patient must have received no more than two lines of IMWG defined therapy (induction +\u002F- transplant + maintenance is considered a single line of therapy)\n* Patient must not receive non-protocol concurrent chemotherapy for the study disease, or any ancillary therapy considered investigational while participating in the study\n* Patient must have received an immunomodulatory drug (lenalidomide) and a CD38 antibody (daratumumab or isatuximab)\n* Patient must have measurable disease as defined by having one or more of the following, obtained within 28 days prior to registration\u002Frandomization:\n\n  * ≥ 0.5 g\u002FdL monoclonal protein (M-protein) on serum protein electrophoresis\n  * ≥ 200 mg\u002F24 hrs of monoclonal protein (M-protein) on a 24-hour urine protein electrophoresis\n  * Involved free light chain ≥ 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\\u003C 0.26 or \\> 1.65)\n  * Exception: patients without measurable disease in the serum or urine, but with bone or soft tissue plasmacytoma(s) ≥ 2 cm or who have bone marrow plasma cells ≥ 30% are eligible on study\n  * NOTE: Urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg\u002F24 hr. Please note that if both serum and urine m-components are present, both must be followed in order to evaluate response.\n* Patient must not be known to be refractory to carfilzomib or pomalidomide\n* Patient must not have received a prior BCMA therapy\n* Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration\u002Frandomization to rule out pregnancy. Patients must also agree to a second pregnancy test completed within 24 hours prior to the first dose of pomalidomide and teclistamab and agree to ongoing pregnancy testing while on protocol treatment\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:\n\n    * Has achieved menarche at some point\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for patients on Arms A, B, and C and for 1 month after the last dose of protocol treatment for patients on Arm D. In addition, all patients must also agree to register to the mandatory Risk Evaluation and Mitigation Strategies (REMS)® program and be willing and able to comply with the requirements of the REMS® program\n* Patient must agree to not breastfeed while on protocol treatment due to the potential risk for adverse events in nursing infants, and must agree to continue not breastfeeding for an additional 5 months after the last dose of Arm A, B, or C protocol treatment and for an additional 28 days after the last dose of Arm D protocol treatment\n* Patient must agree to abstain for donating eggs (ova, oocytes) while on study treatment and for 6 months after the last dose of Arm A, B or C protocol treatment\n* Patient must agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy\n* Patient must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment\n* Patient must not receive non-protocol concurrent chemotherapy, or any ancillary therapy considered investigational while participating in the study\n\n  * NOTE: Bisphosphonates are considered supportive care rather than therapy and are thus allowed while on protocol treatment\n* Patient must not have peripheral neuropathy \\> grade 2 on clinical examination at the time of registration\u002Frandomization\n* Patient must not have known uncontrolled congestive heart failure (CHF), New York Heart Association (NYHA) class III or IV, uncontrolled hypertension as defined as systolic \\> 180 and\u002For diastolic \\> 100, uncontrolled atrial (A) fib, or left ventricular ejection fraction (LVEF) \\\u003C 40% within 6 months prior to registration\u002Frandomization\n* Patient must not have known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 14 days prior to registration\u002Frandomization)\n* Platelets ≥ 100,000\u002FuL (≤ 14 days prior to registration\u002Frandomization)\n* Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) (≤ 14 days prior to registration\u002Frandomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 14 days prior to registration\u002Frandomization)\n* Calculated creatinine clearance ≥ 30 mL\u002Fmin (≤ 14 days prior to registration\u002Frandomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration\u002Frandomization are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with past central nervous system (CNS) involvement are eligible if there is no current CNS involvement\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial",{"count":74,"type":21},162,[24,25],"This phase Ib\u002FII trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Carfilzomib blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. It is a type of proteasome inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving teclistamab and pomalidomide may be safe, tolerable and improve response by lowering myeloma cells to undetectable levels when compared to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with relapsed multiple myeloma.",[28,29],"NOT_YET_RECRUITING","2026-06-26",{"date":81,"type":34},"2026-06-29",{"date":83,"type":21},"2026-07-24",{"date":85,"type":21},"2026-08-31",{"name":63,"class":64},{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100641459","phase-2-infliximab-for-cytokine-release-syndrome-prophylaxis-during-teclistamab-or-talquetamab-therapy-in-patients-with-relapsed-or-refractory-myeloma-100641459","NCT07657312","Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma","Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab\u002FTalquetamab Therapy in Patients With Relapsed\u002FRefractory Myeloma","Inclusion Criteria:\n\n* Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:\n\n  * Serum M-protein ≥ 0.5 g\u002Fdl\n  * Urine monoclonal protein ≥ 200 mg\u002F24h\n  * Involved free light chain (FLC) level ≥ 10mg\u002Fdl (≥ 100mg\u002Fl) and an abnormal serum free light chain ratio (\\\u003C 0.26, or \\> 1.65)\n* Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.\n\n  * Prior B-cell maturating antigen (BCMA) chimeric antigen receptor (CAR)-T is permitted but at least 6 months must have lapsed from CAR-T exposure\n  * Prior tumor necrosis factor alpha (TNFα) inhibitor use for a concomitant condition (ex. Rheumatoid arthritis) is permitted but at least 6 months must have lapsed from exposure\n* Patients must have hemoglobin ≥ 7g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1000\u002FµL\n* Platelets ≥ 50,000\u002FµL\n* Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C 2.5 X the ULN\n* Calculated creatinine clearance of ≥ 30ml\u002Fmin using Modification of Diet in Renal Disease (MDRD) formula\n* Patients must have adequate cardiac function as evidenced by:\n\n  * Left ventricular ejection fraction ≥ 30%; baseline echocardiography (ECHO) is not required if ECHO was done within the preceding 6 months and patients do not have new signs\u002Fsymptoms suggestive of heart failure\n  * No uncontrolled arrhythmias\n  * No New York Heart Association class III-IV heart failure\n  * 12-lead electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤ 470 msec\n* Negative test result for latent tuberculosis at screening\n* Patients must provide informed consent\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2\n* Fertility requirements\n\n  * Women of child bearing potential (WOCBP) must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device \\[IUD\\], hormonal \\[birth control pills, injections, hormonal patches, vaginal rings or implants\\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing and continue to 6 months after study treatment ending or teclistamab\u002Ftalquetamab ending, whichever is longer. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy\n  * Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy\n  * A negative pregnancy test will be required for all WOCBP at screening and within 24 hours before starting treatment drugs, and with each cycle\n  * Breast feeding is not permitted\n  * Male patients must agree to use an adequate method of contraception (latex or synthetic condom) for the duration of the study and up to 6 months after study treatment ending\n  * Criteria also applies to azoospermic males\n  * Males should refrain from sperm donation during this time and continue for 6 months after study treatment ending\n\nExclusion Criteria:\n\n* Patients with Waldenstrom macroglobulinemia, primary amyloid light chain (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome\n* Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment\n* Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs\n* Live vaccines should not be given concurrently with infliximab. Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and least 4 weeks after treatment\n* Clinically active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and\u002For ankylosing spondylitis (AS), or concurrent use of abatacept, anakinra, rituximab, or other biologic products approved to treat these diseases within the preceding 6 months\n* Patients with history of anaphylaxis or hypersensitivity to etanercept, infliximab, adalimumab, certolizumab pegol, or golimumab\n* Unacceptable respiratory risk factors defined by any one of the following criteria:\n\n  * Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal\n  * Moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification\n* Unacceptable cardiac risk factors defined by any of the following criteria:\n\n  * Left ventricular ejection fraction \\\u003C 30%\n  * Complete left bundle branch, bifascicular block or clinically significant abnormal electrocardiogram (EKG) finding at screening\n  * A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval \\> 470 msec using Fridericia's QT correction formula; a family history of Long QT Syndrome\n  * Myocardial infarction within 6 months\n  * Unstable angina\n* Unacceptable infectious risk factors defined by any of the following criteria:\n\n  * Active tuberculosis:\n\n    * History of active or latent tuberculosis (TB) before screening\n    * Any signs or symptoms suggestive of active TB upon medical history and\u002For physical examination\n    * Any known recent close contact with a person with active TB.\n  * Active invasive fungal infections\n  * Other active infections, including clinically important localized infections, and patients with a history of opportunistic infections\n* Unacceptable demyelinating neurologic risk factors including history or active multiple sclerosis, Guillain-Barre syndrome, optic neuritis, or peripheral demyelinating polyneuropathy\n* Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is shorter) and who have not recovered from side effects of those therapies\n* Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery\n* Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required\n* Patients with active hepatitis B (defined as hepatitis B surface antigen positive \\[HBsAg+\\]); hepatitis B virus (HBV) screening is required prior to beginning therapy\n\n  * Patients with prior hepatitis B vaccine are permitted (defined as hepatitis B surface antigen negative \\[HbsAg-\\], anti hepatitis B virus surface antibody positive \\[Anti-HBs+\\], anti hepatitis C virus surface antibody negative \\[Anti-HBc-\\])\n  * Non-active hepatitis B (HbsAg-, Anti-HBs+, Anti-HBc+) may be enrolled if on suppressive antiviral therapy and have no detectable viral load (additional monitoring for hepatitis B reactivation is advised)\n* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix or breast, should not be enrolled\n* Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff\n* Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results",{"count":95,"type":21},35,[25],"This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and\u002For affect the lung\u002Fliver\u002Fkidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and\u002For decreased brain function (possible paralysis and\u002For coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.",[99,28,29],"Cytokine Release Syndrome","2026-06-15",{"date":102,"type":34},"2026-06-18",{"date":104,"type":21},"2026-08-01",{"date":106,"type":21},"2027-12-31",{"name":108,"class":41},"Naresh Bumma",1,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100548490","phase-2-outpatient-and-intermittent-dosing-of-elranatamab-in-relapsedrefractory-multiple-myeloma-100548490","NCT06421675","Outpatient and Intermittent Dosing of Elranatamab in Relapsed\u002FRefractory Multiple Myeloma","A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed\u002FRefractory Multiple Myeloma","EMBRACE","Inclusion Criteria:\n\n1. Relapsed and\u002For refractory MM defined as:\n\n   1. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).\n   2. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).\n2. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:\n\n   1. Serum M-protein ≥ 0.5 g\u002Fdl.\n   2. Urine M-protein excretion ≥ 200 mg\u002F24 h.\n   3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg\u002Fdl (≥ 100 mg\u002Fl) AND an abnormal serum-free light chain ratio (\\\u003C 0.26 or \\> 1.65) only for patients without measurable serum or urine M protein.\n3. Receipt of at least three prior classes of drugs either in separate regimens or as combinations.\n\n   The three classes are defined as:\n\n   An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab).\n4. At least 18 years of age.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.\n\nExclusion Criteria:\n\nMedical conditions\n\n1. Active plasma cell leukemia (either 20% of peripheral white blood cells or \\> 2.0 × 109\u002FL circulating plasma cells by standard differential).\n2. Amyloidosis.\n3. POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).\n4. Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.\n5. Solitary plasmacytoma.\n6. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host disease.\n7. History of prior treatment with a BCMA targeting agent.\n\n   Laboratory Parameters\n8. Laboratory results within 28 days as per below prior to enrollment:\n\n   * Absolute neutrophil count (ANC) ≤ 1.0 x 109 \u002FL) (use of growth factor is permitted if completed at least 7 days prior to enrollment).\n   * Platelet count ≤ 25 x 109 \u002FL (transfusion support permitted if completed at least 7 days prior to enrollment).\n   * Hemoglobin ≤ 8.0 g\u002FdL (transfusion support permitted if completed at least 7 days prior to enrollment, concurrent erythropoietin stimulating agents allowed).\n   * Serum AST and ALT \\> 2.5 x upper limit of normal (ULN).\n   * Creatinine clearance \\\u003C 30 mL\u002Fmin (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).\n   * Total bilirubin \\> 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease).\n\n   Support Requirement\n9. As this protocol requires outpatient administration, the patient will be excluded if they cannot agree to the following for the first 9 days post-first dose of drug administration:\n\n   1. Staying within 60 minutes of travel distance to their trial-based hospital.\n   2. Must have a caregiver\u002Fsupport person who will stay with the patient.\n   3. Patient and\u002For their caregiver\u002Fsupport person agree to monitor and record oral temperature q8 hours.\n   4. Patients must agree that if they have an oral temperature of (≥38°C), they must report to the study team within 1 hour and can come to the hospital for admission within 2 hours.\n\n   Other co-morbidities\n10. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months before enrollment:\n\n    * Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion).\n    * Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).\n    * Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\], or pulmonary embolism).\n    * Prolonged QT syndrome (or triplicate average QTcF \\>470 msec at screening).\n11. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.\n12. History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n13. Unresolved acute effects of any prior therapy for MM in the last three months to either baseline severity or NCI CTCAE ≤Grade 1.\n14. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.\n15. Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n16. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities), or surgical (major surgery within 14 days prior to enrollment) that could interfere with the patient's safety, obtaining informed consent or compliance to the study procedures.\n17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to elranatamab or any of the components of the study treatment.\n\n    Concomitant Medications\n18. Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5 half-lives (whichever is shorter) prior to enrollment or are currently enrolled in another interventional clinical study.\n19. Receipt of any other therapy to treat cancer (including radiation, biologics, cellular therapies, and\u002For steroids at doses \\> 20 mg dexamethasone or equivalent) within 14 days prior to the enrollment.\n20. Receipt of any live vaccine within 30 days prior to enrollment or expected need of live vaccination during study participation. (Administration of locally approved non-live vaccine can be done as per local guidelines during the screening and\u002For treatment period including the COVID-19 mRNA vaccine. Elranatamab should be administered ± 7 days from the SARS-CoV-2 vaccine administration).\n\n    Pregnancy and Contraception\n21. Pregnancy or lactating female or inability of female patients of childbearing potential (FCBP) to meet contraception requirements (see Section 5.1.3.).\n\n    Informed Consent\n22. Inability to provide signed, informed consent.",{"count":119,"type":21},40,[25],"A phase II study of single agent elranatamab in patients with relapsed and\u002For refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and\u002For refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.",[29],[124,125,126,127,128,129],"relapsed","refractory","multiple myeloma","elranatamab","cytokine release syndrome","immune effector-cell associated neurotoxicity",{"date":131,"type":34},"2026-06-17",{"date":133,"type":34},"2025-03-28",{"date":135,"type":21},"2028-12",{"name":137,"class":41},"Ontario Clinical Oncology Group (OCOG)",6,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":109},"100406984","phase-1-at-okt10-b10-and-fludarabine-alone-or-in-combination-with-cyclophosphamide-and-low-dose-tbi-before-donor-stem-cell-transplant-for-the-treatment-of-newly-diagnosed-recurrent-or-refractory-high-risk-multiple-myeloma-100406984","NCT04579523","²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Transplant for the Treatment of Newly Diagnosed, Recurrent, or Refractory High-Risk Multiple Myeloma","A Phase I Trial Evaluating Escalating Doses of ²¹¹At-Labeled Anti-CD38 Monoclonal Antibody Followed by HLA-Matched or Haploidentical Donor Hematopoietic Cell Transplantation for High-Risk Multiple Myeloma","Inclusion Criteria:\n\n* Patients with newly diagnosed or relapsed\u002Frefractory multiple myeloma\n* Patients with multiple myeloma must have at least one of the following high-risk features:\n\n  * t(4;14), t(14;16), t(14;20) or deletion 17p, gain in chromosome 1q (\\> 3 copies of CKS1b) by fluorescence in situ hybridization (FISH); hypodiploidy; complex karyotype\n  * Revised International Staging System III\n  * Plasmablastic morphology\n  * History of primary or secondary plasma cell leukemia\n* Patients must start ²¹¹At-OKT10-B10 within 40-180 days of autologous stem cell transplant (either as part of their induction, or as salvage)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute measured by 24-hour urine collection\n* Total bilirubin \\\u003C 2 times the upper limit of normal\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal)\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2 or Karnofsky \\>= 70\n* Patients must have CD38+ myeloma cells as demonstrated by either flow cytometry or immunohistochemistry in most recent bone marrow that had evidence of clonal plasma cells\n* For patients of childbearing potential, must have a negative urinary pregnancy test on the day of and prior to infusion of ²¹¹At-OKT10-B10\n* Ability to provide informed consent\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutchinson Cancer Center and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n    * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n* Patients without an HLA-matched related or unrelated donor available must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches\n\nExclusion Criteria:\n\n* History of central nervous system involvement by multiple myeloma\n* Presence of circulating plasma cells in the peripheral blood of 5% or more by flow cytometry or morphology\n* Prior radioimmunotherapy or radiation of \\> 20 Gy to pelvis or at maximally tolerated levels to any critical normal organ\n* Prior allogeneic HCT\n* More than two prior autologous HCTs\n* Patients with plasmacytomas \\> 1 cm in bone marrow or any extramedullary plasmacytoma. Previously fludeoxyglucose F-18 (FDG) avid mass lesions by positron emission tomography (PET) that are no longer hypermetabolic following the most recent cycle of therapy are exempt, as are plasmacytomas irradiated with curative intent (\\>= 35 Gy)\n* Patients with symptomatic coronary artery disease defined as having angina or anginal equivalent, and\u002For arrhythmias requiring anti-arrhythmics for rhythm control\n* History of reactive airway disease and clinically significant asthma requiring ongoing treatment\n* Patients with the following organ dysfunction:\n\n  * Left ventricular ejection fraction \\\u003C 40% in patients with HLA-matched or unrelated donor or \\\u003C 45% in patients with an HLA-haploidentical donor\n  * New York Heart Association (NYHA) class \\> 1 heart failure\n  * Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 50% or receiving supplemental continuous oxygen. When pulmonary function tests cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 90% during a 6MWT will be excluded\n  * Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin \\[HCG\\]+) or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Uncontrolled or untreated active infection\n* Patients with known AL subtype amyloidosis\n* Inability to understand or give an informed consent\n* Known allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy\n* History of another primary malignancy that has not been in remission for at least 2 years. The following are exempt from the 2-year-limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, or cervical carcinoma in situ or squamous intraepithelial lesion on papanicolaou (PAP) smear\n* Therapy with anti-CD38 monoclonal antibody within 3 months of ²¹¹At-OKT10-B10 infusion\n* Prior therapy with radiolabeled monoclonal antibodies\n* Any history of treatment with checkpoint inhibitor\u002Fs","70 Years",{"count":148,"type":21},30,[24],"This phase I trial investigates the side effects and best dose of ²¹¹At-OKT10-B10 when given together with fludarabine, alone or in combination with cyclophosphamide and low-dose total-body irradiation (TBI) before donor stem cell transplant in treating patients with high-risk multiple myeloma that is newly diagnosed, has come back (recurrent), or does not respond to treatment (refractory). ²¹¹At-OKT10-B10 is a monoclonal antibody, called OKT10-B10, linked to a radioactive agent called ²¹¹At. OKT10-B10 attaches to CD38 positive cancer cells in a targeted way and delivers ²¹¹At to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy such as TBI uses high energy x-rays to kill cancer cells and shrink tumors. Giving ²¹¹At-OKT10-B10 together with chemotherapy and TBI before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.",[152,28,29],"Multiple Myeloma","2026-06-02",{"date":155,"type":34},"2026-06-04",{"date":157,"type":21},"2027-06-01",{"date":159,"type":21},"2029-12-31",{"name":161,"class":41},"Fred Hutchinson Cancer Center",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":109},"100638264","a-cognitive-training-intervention-for-improving-cognitive-and-neurological-outcomes-in-patients-undergoing-treatment-for-relapsed-or-refractory-multiple-myeloma-or-b-cell-non-hodgkin-lymphoma-100638264","NCT07609030","A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma","Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)","Inclusion Criteria:\n\n* Patients \\>= 18 years of age\n* Diagnosed with relapsed\u002Frefractory multiple myeloma (MM) or B-cell non-Hodgkin lymphoma (B-NHL)\n* Expected to receive an Food and Drug administration (FDA)-approved CAR-T cellular treatment\n* English literacy\n\nExclusion Criteria:\n\n* Patients expected to live \\\u003C 6 months\n* Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery\n* Confirmed Alzheimer disease or other dementia\n* Previous central nervous system (CNS) radiation\n* Active intrathecal therapy at time of enrollment",{"count":170,"type":21},90,[172],"NA","This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity \\[I-CAN\\]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Cancer treatment can have significant short and long-term side effects, including cognitive and neurological side effects such as impairments in attention, memory, language, and executive function. The I-CAN program is a form of cognitive training. Cognitive training is a therapeutic approach designed to improve and restore cognitive functioning, based on the brain's ability to reorganize and form new neural connections to accomplish tasks. I-CAN provides five core elements necessary for training the brain to create new neural connections including speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.",[175,28,176,29],"Recurrent B-Cell Non-Hodgkin Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma","2026-05-19",{"date":179,"type":34},"2026-05-27",{"date":181,"type":34},"2026-04-28",{"date":106,"type":21},{"name":184,"class":41},"Ohio State University Comprehensive Cancer Center",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":207},"100549432","phase-1-study-to-assess-safety-and-tolerability-of-opn-6602-in-subjects-with-relapsed-andor-refractory-multiple-myeloma-100549432","NCT06433947","Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and\u002For Refractory Multiple Myeloma","A Phase 1b, Dose Escalation\u002FDose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Confirmed diagnosis of multiple myeloma (MM)\n* Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit\n* Adequate hematologic, renal, liver, cardiac function\n\nExclusion Criteria:\n\n* Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma\n* Active plasma cell leukemia\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)\n* Prior Stevens Johnson syndrome\n* Localized radiation therapy to disease site(s) within 2 weeks of the first dose\n* Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \\\u003C90 days of the first dose of study drug\n* Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.\n* Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug\n* Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)\n* Known central nervous system involvement by multiple myeloma\n* Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \\\u003C7 and a PSA level \\\u003C10 ng\u002FmL; any other cancer from which the subject has been disease-free for ≥3 years\n* Ongoing systemic infection requiring parenteral treatment\n* Poorly controlled Type 2 diabetes",{"count":193,"type":21},130,[24],"Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and\u002For refractory MM.",[197,29],"Relapsed Multiple Myeloma","2026-05-15",{"date":177,"type":34},{"date":201,"type":34},"2024-08-22",{"date":203,"type":21},"2026-07",{"name":205,"class":206},"Opna Bio LLC","INDUSTRY",12,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":109},"100629846","phase-1-study-of-selinexor-with-carfilzomib-isatuximab-and-dexamethasone-for-patients-with-relapsed-andor-refractory-multiple-myeloma-100629846","NCT07479979","Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and\u002For Refractory Multiple Myeloma","Phase Ib\u002FII Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and\u002For Relapsed Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \\>2 will be allowed only if it is related to bone pain that is expected to improve with treatment.\n4. Patients with a diagnosis of relapsed or relapsed\u002Frefractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will specifically enrich for patients with 1q gain or amplification as well as other IMWG high-risk features with the aim of including ≥50% of the enrolled population (a minimum of 25 patients) with high risk disease. High risk disease is defined as the presence of:\n\n   * del(17p), with a cutoff of \\>20% clonal fraction, and\u002For TP53 mutation\n   * an IgH translocation including t(4;14), t(14;16), or t(14;20) along with 1q+ and\u002For del(1p32)\n   * monoallelic del(1p32) along with 1q+ or biallelic del(1p32)\n   * β2 microglobulin ≥5.5 mg\u002FL with normal creatinine (\\\u003C1.2 mg\u002FdL) For purposes of the study, patients with 2 or more of these high risk cytogenetic abnormalities. Patients known to carry such abnormalities on previous FISH analysis and\u002For cytogenetic testing will also be eligible, if results from on-study marrow are unavailable or not obtainable. Therefore, enrollment of patients without these feature(s) will halt once 25 standard risk, non-mutated patients are enrolled and treated. Refractory is defined as patients relapsing on or within 60 days of therapy, per IMWG.\n5. Patients must have measurable disease as defined by at least one of the following:\n\n   1. A monoclonal protein (M-protein): ≥ 0.5g\u002FdL on serum protein electrophoresis or ≥ 200 mg of monoclonal protein on a 24-hour urine protein or involved serum light chain ≥ 10 mg\u002Fdl at time of relapse, or\n   2. Biopsy proven plasmacytoma that can be assessed by physical exam or imaging, or\n   3. If non- or oligo secretory, ≥10% plasma cells on BM biopsy\u002Faspirate at time of relapse or plasmacytoma as described and\u002For evaluable disease by positron emission tomography, either MR or CT. Patients must be willing to undergo repeat BM aspirate and biopsy to assess response.\n   4. Due to the difficulty of quantitation using conventional SPEP of IgA and IgD monoclonal proteins, an absolute increase of \\> 25 % over previous nadir of the total values in mg\u002Fdl (or adjusted units) will meet eligibility requirements for progression and study eligibility.\n\n   NOTE: Urine protein electrophoresis (UPEP) (on a 24-h collection) is required at baseline; no substitute method is acceptable. Urine must be assessed to establish response if the baseline urine M-spike is ≥ 200 mg\u002F24 h. Please note that if both serum and urine M-components are present at the time of enrollment, both should be assessed in order to evaluate response for CR but monthly 24 hour urine tests outside of this response testing are not necessary. For patients without a monoclonal urine protein ≥200mg\u002F24 hours, the test only needs to be repeated to corroborate CR.\n6. Patients may have received any number and type of previous treatments for myeloma including carfilzomib and an anti-CD38 antibody but cannot be refractory to the combination of daratumumab and carfilzomib.\n7. Patients may not have received any anti-CD38 therapy within 6 months of start of study treatment (not enrollment).\n8. Previous allogeneic transplant is allowed provided the patient is not receiving ongoing systemic therapy for graft-versus-host disease (GVHD).\n9. Previous B-cell maturation antigen (BCMA)-directed therapy, including chimeric antigen receptor T-cell therapy (CAR-T) transplantation, antibody drug conjugates, or bispecific engagers is also allowed, provided there is no evidence of residual cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome. In addition, other T cell redirecting therapy exposure is permitted as well.\n10. Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n    * White blood cell (WBC): ≥ 1,500\u002Fmm3\n    * Absolute Neutrophil Count (ANC): ≥ 1,000\u002Fmm3 a (For subjects with known Duffy null phenotype (benign ethnic neutropenia), the lowest acceptable ANC will be 750\u002Fmm3)\n    * Platelet Count: ≥75,000\u002Fmm3\n    * Hemoglobin (Hgb): ≥ 8 g\u002FdL\n    * Calculated creatinine clearance: ≥ 20 cc\u002Fmin using the Cockcroft-Gault formula\n    * Total Bilirubin: ≤ 2 × upper limit of normal (ULN) (except patients with suspected Gilbert's syndrome \\[hereditary indirect hyperbilirubinemia\\] who must have a total bilirubin of ≤ 3x ULN)\n    * Aspartate aminotransferase (AST): ≤ 3 × ULN\n    * Alanine aminotransferase (ALT): ≤ 3 × ULN\n11. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 7 days prior to registration.\n12. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). Male participants must agree not to donate sperm during this same time period.\n13. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n14. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment and absolute lymphocyte count is ≥ 350\u002Ful. Such subjects may stay on antiviral therapy during study treatment.\n15. Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection may be enrolled if the viral load by PCR is undetectable with\u002Fwithout active treatment. Such patients may stay on viral therapy while on treatment. Due to a potential HBV and HepC reactivation risk with carfilzomib, the subjects are required to have HBs Ag and HBc Ab screening.\n16. Subject willing to provide mandatory bone marrow biopsy and peripheral blood laboratory testing for research purposes only.\n\nExclusion Criteria:\n\n1. Active infection requiring systemic therapy (Note: subjects can be enrolled if they will be completing antibiotic therapy by the time of actual start date of treatment)\n2. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n3. Known additional malignancy that is active and\u002For progressive, requiring urgent or new treatment. Exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, prostate cancer on stable hormonal therapy, DCIS or other cancer for which the subject has been disease-free for at least three years. Patients who have undergone a curative procedure for another malignancy are eligible.\n4. Active central nervous system (CNS) metastases. NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.\n5. History of severe hypersensitivity reaction (grade 3 or more) to an anti-CD38 antibody that in the opinion of the investigator excludes the use of these drugs.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III and IV), unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Treatment with any investigational drug within 14 days prior to registration.\n8. Any previously active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment. This is likely to be a rare occurrence.\n9. Treatment with moderate or strong inhibitors\u002Finducers of CYP3A within 7 days prior to Day 1 of Cycle 1. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, and St. John's Wort. For patients receiving diltiazem or verapamil, alternative therapy will need to be substituted, if necessary, if the drug cannot otherwise be safely discontinued.\n10. Currently receiving a strong CYP3A4 inhibitor\u002Finducer and unable to discontinue such medications.\n11. Prior exposure to a SINE compound, including selinexor.\n12. Exposure to anti-CD38 directed therapy (ex. daratumumab; isatuximab; daratumumab\u002Fhyaluronidase) within 6 months of study registration.\n13. Patients with an echocardiogram or other cardiac imaging study showing a LVEF of \\\u003C40% within 60 days of study registration.\n14. Presence of plasma cell leukemia at time of registration\n15. Patients with a history of POEMS syndrome or primary AL amyloidosis are excluded",{"count":216,"type":21},62,[24,25],"The primary objective of this Phase Ib\u002FII trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed\u002Frefractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.",[220,29],"Relapse Multiple Myeloma","2026-05-12",{"date":223,"type":34},"2026-05-14",{"date":203,"type":21},{"date":226,"type":21},"2029-07",{"name":228,"class":41},"Natalie Callander",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":4},"100588951","phase-2-testing-the-investigational-medication-combination-of-daratumumab-and-teclistamab-compared-to-the-usual-treatment-daratumumab-pomalidomide-dexamethasone-or-daratumumab-carfilzomib-dexamethasone-for-patients-with-high-risk-multiple-myeloma-refractory-or-in-first-relapse-100588951","NCT06948084","Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse","A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)\n* Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay\n* Patient must have received only one prior line of therapy\n\n  * One prior line of systemic therapy is defined as 1 or more cycles of single agent or combination therapy, as well as a series of treatment regimens administered in a sequential manner (e.g., lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide +\u002F- proteasome inhibitor or anti-CD38 monoclonal antibody (mAb) maintenance therapy would be considered 1 line of prior therapy)\n  * NOTE: Autologous stem cell transplant is allowed provided the stem cell infusion was \\> 90 days prior to randomization. Allogeneic stem cell transplantation (SCT) patients are ineligible\n* Patient must be diagnosed with relapsed or refractory (RR) multiple myeloma, as defined by disease progression, either an increase in serum or urine M protein of any level, or other evidence of progression biochemical or clinical as specified in the IMWG progression criteria (including disease which becomes non-responsive or progressive on therapy or within 60 days of the last treatment in patients who had achieved a partial response or better on prior therapy)\n* Patient must be daratumumab-hyaluronidase (or isatuximab) naïve or daratumumab-hyaluronidase (or isatuximab) sensitive and \\> 180 days from their last dose of daratumumab-hyaluronidase (or isatuximab) at the time of randomization\n* Patient must have high-risk multiple myeloma (HR-MM) as defined by one of the following either at diagnosis or at refractory status or at first relapse:\n\n  * Evidence of deletion 17p by fluorescence in situ hybridization (FISH) testing on bone marrow\n  * Evidence of t(4;14) by FISH testing on bone marrow\n  * Evidence of t(14;16) by FISH testing on bone marrow\n  * Evidence of t(14;20) by FISH testing on bone marrow\n  * Evidence of chromosome 1 abnormalities either gain\u002Famp 1q or deletion 1p by FISH testing on bone marrow OR\n  * Evidence of non-hyperdiploid karyotype OR\n  * Revised International Staging System (R-ISS) stage III beta2 microglobulin ≥ 5.5 mg\u002FL and serum lactate dehydrogenase (LDH) \\> institutional upper limit of normal (ULN) OR\n  * Patient in first relapse and ≤ 24 months from the start of induction for both allogeneic stem cell transplantation (ASCT) eligible or ASCT ineligible patients (regardless of FISH, cytogenetic or RISS stage)\n* Patient must have measurable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:\n\n  * Serum M protein ≥ 0.5 g\u002FdL (≥ 5 g\u002FL)\n  * Urine M protein ≥ 200 mg\u002F24 hours\n  * Serum free light chain (FLC) assay: Involved free light chain level ≥ 10 mg\u002FdL (≥ 100 mg\u002FL) provided serum FLC ratio is abnormal (\\\u003C 0.26 or \\> 1.65)\n  * Exception: patients without measurable disease in the serum or urine, but with bone or soft tissue plasmacytoma(s) ≥ 2 cm or who have bone marrow plasma cells ≥ 30% are eligible on study\n* Patient must have serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum FLC assays along with bone marrow biopsy or aspirate performed within 28 days prior to randomization\n\n  * NOTE: UPEP (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg\u002F24 hr. If both serum and urine M-components are measurable, both must be followed in order to confirm response\n  * NOTE: The serum free light chain test is required to be done at each cycle\n* Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure), or known sensitivity to mammalian-derived products\n* Patients who have received prior systemic therapy for myeloma, including experimental therapy and steroids must have recovered from clinically significant adverse events prior to randomization\n* Patient may not be on steroids (prednisone \\> 40mg\u002Fday or equivalent) at the time of randomization\n* Patient may have received prior palliative and\u002For localized radiation, provided that it is completed by the time of randomization\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FuL (=\\\u003C 28 days prior to protocol randomization)\n* Untransfused platelet count ≥ 50,000\u002FuL (for patients with ≥ 50% plasma cells in the marrow) and untransfused platelet count \\> 75,000\u002FuL (for patients with \\\u003C 50% plasma cells in the marrow) (=\\\u003C 28 days prior to protocol randomization)\n* Untransfused hemoglobin ≥ 8.0 g\u002FdL (=\\\u003C 28 days prior to protocol randomization)\n* Total bilirubin ≤ 1.5 x institutional ULN (upper limit of normal) (=\\\u003C 28 days prior to protocol randomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN (=\\\u003C 28 days prior to protocol randomization)\n* Calculated creatinine clearance \\> 30 mL\u002Fmin (=\\\u003C 28 days prior to protocol randomization)\n\n  * NOTE: Cockcroft-Gault equation should be used to calculate creatinine clearance\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 prior to randomization to rule out pregnancy. Patients randomized to Arm A and to receive the daratumumab-hyaluronidase, pomalidomide, dexamethasone (DPd) regimen must also have a second pregnancy test within 24 hours prior to the first dose of pomalidomide and agree to ongoing pregnancy testing while on protocol treatment\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 5 months after the last dose of protocol treatment for patients on Arm B and for 3 months after the last dose of protocol treatment for patients on Arm A. In addition, patients randomized to Arm A and receive the daratumumab-hyaluronidase, pomalidomide, dexamethasone (DPd) regimen must also agree to register to the mandatory Risk Evaluation and Mitigation Strategies (REMS®) program and be willing and able to comply with the requirements of the REMS program. All patients must not breastfeed while on protocol treatment and for patients on Arm B they must not breastfeed for an additional 5 months after the last dose of protocol treatment\n* Patient may have primary plasma cell leukemia (pPCL), secondary plasma cell leukemia (sPCL) or extramedullary myeloma (EMM)\n* Patient must not have evidence of active or untreated central nervous system (CNS) positive MM. Patients with prior CNS involvement are eligible provided they had demonstrated evidence of CNS disease resolution by imaging and\u002For 2 consecutively negative cerebrospinal fluid (CSF) samples for the presence of plasma cells\n* Patient must not have active autoimmune disease\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients with a history of chronic obstructive pulmonary disease (COPD) must have forced expiratory volume in 1 second (FEV1) testing done within 28 days prior to randomization and the forced expiratory volume in 1 second (FEV1) must be \\>= 50% of predicted normal\n* Patient must not have moderate or severe persistent asthma within 2 years prior to randomization\n\n  * NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are eligible\n* Investigator must declare the intended chemotherapy regimen at the time of randomization should their patient be randomized to Arm A from the two options",{"count":237,"type":21},80,[25],"This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.",[28,29],{"date":242,"type":34},"2026-05-13",{"date":244,"type":21},"2026-08-26",{"date":246,"type":21},"2028-02-28",{"name":63,"class":64},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":109},"100440833","phase-1-tripril-car-t-cells-in-multiple-myeloma-100440833","NCT05020444","TriPRIL CAR T Cells in Multiple Myeloma","A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Age ≥18 years at the time of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Life expectancy of greater than 12 weeks\n* Histologically or cytologically confirmed diagnosis of relapsed\u002Frefractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:\n\n  * Serum M-protein ≥1.0 g\u002FdL\n  * Urine M-protein ≥200 mg\u002F24 hours\n  * Involved serum free light chain ≥100 mg\u002FL with abnormal κ\u002Fλ ratio\n  * Bone marrow plasma cells ≥30%\n* Relapsed\u002Frefractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has \"triple-refractory\" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.\n\nNote: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.\n\n* Adequate organ and marrow function as defined below:\n\n  * O2 saturation ≥92% on room air while awake\n  * LVEF ≥40% by ECHO or MUGA scan\n  * ANC ≥1.0k\u002Fμl, PLT ≥50k\u002Fμl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)\n  * Creatinine clearance ≥30 mL\u002Fmin and not on dialysis\n  * AST\u002FALT \\\u003C3 x ULN\n  * Direct bilirubin \\\u003C1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)\n  * PTT, PT\u002FINR \\\u003C1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Patients with any history of thromboembolic stroke; or history or Grade 2 or greater hemorrhage within 60 days are excluded)\n* Resolution of AEs from any prior therapy to ≤ Grade 1 (≤ G2 alopecia and ≤ G2 sensory neuropathy are allowed, cytopenias allowed per eligibility criteria above)\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* The effects of TriPRIL CAR T cells on the developing human fetus are unknown. Male and female participants of childbearing potential must agree to use highly effective methods of birth control prior to study entry, for the duration of study participation, and through 6 months after completion of TriPRIL CAR T cells administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nNOTE: Highly effective contraception methods include:\n\n* Total abstinence\n* Female sterilization (tubal ligation, bilateral oophorectomy, and\u002For hysterectomy)\n* Male sterilization, at least 6 months prior to screening\n* Intrauterine device\n* Oral, injected, or implanted hormonal contraception AND barrier methods of contraception\n\n  * Willing to comply with and able to tolerate study procedures, including Long-term Safety Follow-up lasting up to 15 years per FDA guidance\n\nExclusion Criteria:\n\n* Treatment with any of the following therapies as specified below:\n\n  * Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor\n  * Receiving high-dose (e.g., \\>10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis\n  * Autologous stem cell transplantation within 3 months prior to leukapheresis\n  * Any prior allogeneic stem cell transplantation\n  * Other CAR-T cell therapy within 6 months of leukapheresis\n* Plasma cell leukemia or history of plasma cell leukemia\n* Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.\n* No Bispecific T cell engagers withing 6 months of apheresis\n* No bendamustine within 6 months of apheresis\n* Patients with solitary plasmacytomas without evidence of other measurable disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CAR- T cells\n* Contraindication to the protocol-specified doses of fludarabine or cyclophosphamide\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of ≤ G2 alopecia and grade ≤2 sensory neuropathy.\n* Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, e.g., related to disease)\n* Symptomatic congestive heart failure\n* Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to screening\n* Significant pulmonary dysfunction\n* Auto-immune disease requiring immunosuppressive therapy\n* Pulmonary embolism or DVT within three months of enrollment or uncontrolled thromboembolic events. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT or PE if greater than three months from time of enrollment. Prophylactic anticoagulation is allowed.\n* Recent severe hemorrhage (within the past 60 days)\n* Seropositive for and with evidence of active hepatitis B or C infection at time of screening, or HIV seropositive\n\n  * Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months are eligible\n  * Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible\n  * Subjects who had hepatitis C but have received antiviral therapy and show no detectable HCV viral RNA for 6 months are eligible\n* Active central nervous system (CNS) involvement by malignancy. NOTE: subjects who are asymptomatic, stable, and received prior effective treatment for CNS disease may be eligible after discussion with the medical monitor.\n* Any sign of active or prior CNS pathology including history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis.\n* Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the medical monitor.\n* Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control\n* Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk\n* Participants taking any other medicine concurrently that may interfere with the study (need to consult with the principle investigator)",{"count":256,"type":21},18,[24],"This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.\n\nThis research study involves the study drugs:.\n\n* TriPRIL CAR T Cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[152,260,29],"Multiple Myeloma in Relapse",[152,260,29],"2026-05-08",{"date":221,"type":34},{"date":265,"type":34},"2021-10-05",{"date":267,"type":21},"2028-02-24",{"name":269,"class":41},"Marcela V. Maus, M.D.,Ph.D.",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":109},"100621962","phase-1-dcmm-fusion-vaccine-with-bcma-car-t-in-rr-mm-100621962","NCT07377435","DC\u002FMM Fusion Vaccine With BCMA CAR-T in R\u002FR MM","Phase I Study of Vaccination With DC\u002FMM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma\n* Patients must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment.\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients receiving other investigational drugs\n* Patients with Plasma Cell Leukemia\n\n  * Patients who have known active uncontrolled infections with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)\n  * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding.\n* Prior organ transplant requiring immunosuppressive therapy.\n* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of intolerance to CAR-T related drugs or GM-CSF.\n\nInclusion Criteria Prior to Vaccination with DC\u002FMM Fusions:\n\n* Resolution of all CAR T- related grade 3-4 toxicities\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells\n* Absence of disease progression following CAR T-cell therapy\n* ECOG performance status ≤ 2\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine within normal limits or Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n  * ANC \\>1000 in the absence of growth factor support in the prior 7 days\n  * Platelet count \\>50K without the need for transfusion in the prior 7 days\n  * No myeloma-directed therapy following administration of CAR T-cells",{"count":7,"type":21},[24],"This study is to evaluate the safety and effectiveness of dendritic cell DC\u002FMM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed\u002Frefractory multiple myeloma.\n\nThe names of the study drugs involved in this study are:\n\n* DC\u002FMM fusion vaccine (a type of personalized cancer vaccine)\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)",[152,29,220],[152,29,197,282],"MM","2026-05-04",{"date":262,"type":34},{"date":286,"type":34},"2026-01-30",{"date":288,"type":21},"2032-03-01",{"name":290,"class":41},"David Avigan",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100577494","phase-1-a-phase-1-study-of-vaccination-with-dendritic-cell-dcmultiple-myeloma-mm-fusions-in-combination-with-elranatamab-in-relapsed-or-refractory-multiple-myeloma-100577494","NCT06799026","A Phase 1 Study of Vaccination With Dendritic Cell (DC)\u002FMultiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma","Inclusion Criteria for Tumor Collection:\n\n* Participants must have an established diagnosis of multiple myeloma\n* Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy\n* Participants must have at least 3 prior lines of therapy\n* Participants must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have \\> 20% plasma cells in the bone marrow core or aspirate differential \\\u003C30 days prior to enrollment.\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin ≤1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Tumor Collection:\n\n* Patients who are receiving any other investigational agents.\n* Patients with purely non-secretory MM \\[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \\>100 mg\u002FL\\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.\n* Patients with Plasma Cell Leukemia\n* Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).\n* Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Active and clinically significant autoimmune or inflammatory disorder requiring active treatment\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding\n* Prior organ transplant requiring immunosuppressive therapy.\n* Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n\nEligibility Criteria Prior to Vaccination with DC\u002FMM fusions\n\n* Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary.\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine\n* Absence of disease progression following 2 cycles of elranatamab therapy\n* ECOG performance status ≤ 2\n\nParticipants must have adequate organ function as defined below:\n\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal\n* AST ≤ 3 x institutional upper limit of normal\n* ALT ≤ 3 x institutional upper limit of normal\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal",{"count":7,"type":21},[24],"This research is being done to determine if the combination of the Dendritic Cell (DC)\u002F Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).\n\nThe names of the study drugs and vaccine involved in this study are:\n\n* DC\u002FMM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)\n* Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)\n* Elranatamab (a type of T-cell engager antibody)",[152,220,29],[282,152,220,29],{"date":303,"type":34},"2026-05-07",{"date":305,"type":34},"2025-01-31",{"date":307,"type":21},"2030-09-01",{"name":290,"class":41},2,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":109},"100563887","phase-1-sx-682-in-combination-with-carfilzomib-daratumumab-hyaluronidase-and-dexamethasone-in-patients-with-relapsed-or-refractory-multiple-myeloma-100563887","NCT06622005","SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","Phase 1 Trial of SX-682, a CXCR 1\u002F2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)","Inclusion Criteria:\n\n* Confirmed relapsed\u002F refractory multiple myeloma\n* Measurable disease including at least one of the following criteria:\n\n  * Serum M-protein ≥ 0.5 g\u002FdL\n  * Urine M-protein ≥ 200 mg\u002F24h\n  * Serum free light chain assay: involved free light chain (FLC) level greater or equal to 100 mg\u002FL provided serum free light chain ratio is abnormal\n  * Bone marrow plasma cells ≥ 10% total bone marrow cells\n* ≥ 1 prior line of therapy\n* Planned treatment with a carfilzomib\u002Fdaratumumab\u002Fdexamethasone regimen\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Absolute neutrophil count: ≥ 3 x 10\\^9\u002FL\n* Platelets: ≥ 75 x 10\\^9\u002FL\n* Hemoglobin: ≥ 7 g\u002FdL\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN): ≤ 3.0 x ULN for Gilbert's syndrome\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 x ULN\n* Renal Function: Estimated creatinine clearance ≥ 45 mL\u002Fmin (Cockroft-Gault)\n* Left ventricular ejection fraction of at least 50%\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months following the last dose of the investigational drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with non-secretory myeloma, systemic light chain amyloidosis or, plasmacytoma\n* Intolerance to SX-682 or any other of the treatment components\n* Refractory to prior carfilzomib (i.e. relapse or progression on or within 60 days after completion of treatment)\n* Refractory to prior daratumumab (i.e. relapse or progression on or within 60 days after completion of treatment)\n* Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative medication\n* Electrocardiogram (ECG) demonstrating a corrected QT (QTc) interval \\> 470 msec or patients with congenital long QT syndrome\n* Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, class III or IV heart failure (New York Heart Association functional classification system) or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of hepatitis B, C or HIV\n* Known active bacillus tuberculosis infection\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":318,"type":21},15,[24],"This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become \"free\" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma",[28,29],"2026-04-16",{"date":324,"type":34},"2026-04-21",{"date":326,"type":34},"2025-04-10",{"date":328,"type":21},"2030-04-10",{"name":330,"class":41},"Roswell Park Cancer Institute",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":351,"locationsCount":109},"100609934","phase-1-ft836-car-t-cell-therapy-in-combination-with-daratumumab-in-patients-with-relapsed-andor-refractory-multiple-myeloma-100609934","NCT07221032","FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must ≥18 years and \\\u003C 80 years old.\n2. Patients must have received \\>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:\n\n   • International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy.\n3. Patients must have measurable disease, including at least one or more of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002Fdl;\n   2. Urine M-protein ≥ 200 mg\u002F24 hrs;\n   3. Involved serum light chain ≥100 mg\u002FL with abnormal light chain ratio;\n4. Karnofsky performance score ≥70.\n5. Adequate hepatic function, defined as:\n\n   1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C3x upper limit of normal (ULN);\n   2. Serum bilirubin \\\u003C2.0 mg\u002FdL except for patients with Gilbert's syndrome, who must have serum bilirubin of \\\u003C3 mg\u002FdL.\n6. Absolute neutrophil count (ANC) ≥1,000 with no G-CSF within 72 hours or pegylated G-CSF within 10 days.\n7. Platelets ≥50,000 with no transfusion within 72 hours of eligibility testing.\n8. Adequate renal function, defined as creatinine clearance ≥50 mL\u002Fmin calculated using the Cockroft-Gault formula.\n9. Able to provide written informed consent.\n10. Agree to practice birth control during the study.\n11. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.\n12. Expected survival \\>12 weeks.\n13. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n14. No contraindication to central line access. Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of the eligibility criteria. Lactating women are eligible for this study but will be asked not to provide breast milk to their child from Day -11 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double-barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.\n\nExclusion Criteria:\n\n1. Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.\n6. Refusal to participate in the long-term follow-up protocol.\n7. Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before start of daratumumab and a remission documented within four weeks of planned CAR T-cell infusion by MRI brain and Cerebrospinal Fluid (CSF) analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.\n10. Prior treatment with gene therapy or any gene-modified cellular therapy.\n11. Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of starting daratumumab or after starting daratumumab.\n\n    1. Corticosteroids are allowable up until seven days prior to starting daratumumab and after starting daratumumab for disease control up until the day prior to cell infusion (Day -1).\n    2. Radiation is allowed to a single symptomatic site.\n12. Patients post solid organ transplant who develop high-grade lymphomas or leukemias.\n13. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n14. Active bacterial, viral, or fungal infection requiring systemic treatment.\n15. Patients who have received major surgery one week prior to starting daratumumab and three weeks prior to lymphodepletion.\n16. Active malignancy that required therapy in the last two years except successfully treated non-metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.","80 Years",{"count":207,"type":21},[24],"This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and\u002For refractory myeloma who have failed prior therapies.",[220,29],[126,344],"CAR-T therapy","2026-04-09",{"date":347,"type":34},"2026-04-14",{"date":203,"type":21},{"date":350,"type":21},"2030-03",{"name":352,"class":41},"Medical College of Wisconsin",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":370,"locationsCount":109},"100606929","phase-1-response-based-dose-reduction-of-linvoseltamab-in-the-treatment-of-relapsed-refractory-or-triple-class-relapsedrefractory-multiple-myeloma-100606929","NCT07181941","Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed\u002FRefractory Multiple Myeloma","Pharmacodynamically Monitored Linvoseltamab Dosing De-Escalation in Relapsed Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥ 18 years. Myeloma is not seen in the younger age group and safety of B-cell maturation antigen (BCMA) T-cell engagers (TCE) in this group is not known\n* Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants\n* Confirmed diagnosis of active multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria\n* Patients must have myeloma that is measurable and response evaluable according to 2016 IMWG response criteria. Measurable disease is defined as one of the following, documented ≤ 14 days prior to registration:\n\n  * Serum M protein ≥ 1 g\u002Fdl\n  * Urine M protein ≥ 200 mg\u002F24h\n  * Free light chain (FLC) assay with involved FLC ≥ 10 mg\u002Fdl and abnormal FLC ratio\n  * A patient with immunoglobulin A (IgA) MM without measurable M protein may be enrolled if quantitative (quant) IgA level ≥ 400 mg\u002Fdl and can be followed longitudinally\n  * Plasmacytoma target lesion defined as measurable based on at least 1 soft tissue lesion ≥ 2 cm in long axis on CT or PET\u002FCT, if not previously irradiated\n  * Skin lesions ≥ 2 cm in long axis as measured with a ruler\n* Patients with relapsed or refractory myeloma who have received at least 4 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory imide drug (IMiD), and anti-CD38 monoclonal antibody\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* Adequate organ function (based on testing ≤14 days prior to registration):\n\n  * Adequate hematologic function before dosing as measured by:\n\n    * Platelet count ≥50 x 10⁹\u002FL. A patient may not have received a platelet transfusion ≤7 days in order to meet this platelet eligibility requirement\n    * Absolute neutrophil count (ANC) ≥1.0 x 10⁹\u002FL. A patient may not have received granulocyte colony stimulating factor (G-CSF) ≤2 days in order to meet this absolute neutrophil count eligibility requirement\n    * Hemoglobin ≥8.0 g\u002FdL\n  * Adequate renal and hepatic function, defined as:\n\n    * Total bilirubin ≤1.5 x ULN\n    * Transaminase (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\]) ≤2.5 x ULN\n    * Alkaline phosphatase ≤2.5 x ULN\n\n      * Patients with Gilbert syndrome do not need to meet this total bilirubin requirement provided that the total bilirubin is unchanged from the baseline value\n    * Serum creatinine clearance by Cockcroft-Gault ≥30 mL\u002Fmin. A patient with a creatinine clearance by Cockcroft-Gault who does not meet eligibility criteria may be considered for enrollment per principal investigator discretion if a measured creatinine clearance (based on 24-hour urine collection or other reliable method) is ≥30 mL\u002Fmin\n* Prior treatment with BCMA-targeted antibody-drug conjugates (ADCs) is allowable if all adverse events (AEs) attributable to these therapies have resolved to grade 1 or lower\n* Willing and able to comply with clinic visits and study-related procedures and provide informed consent signed by study patient\n\nExclusion Criteria:\n\n* Diagnosis of known plasma cell leukemia, known primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), known Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n* Patients with known MM brain lesions or meningeal involvement\n* History of known neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment\n* Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug\n* Live or live attenuated vaccines with replicating potential within 28 days prior to first study drug administration\n* Previous treatment with chimeric antigen receptor (CAR) T therapy or any gene therapy products\n* Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 2 weeks of first administration of study drug\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)\n* Known allergy or hypersensitivity to components of linvoseltamab (REGN5458)\n* Women of childbearing potential (WOCBP) with a positive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test are ineligible for this study\n\n  * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Post-menopausal state is defined as no menses for 12 months without an alternate medical cause\n* Participants who are receiving other investigational agents\n* Women of childbearing potential (WCOBP) and men who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Another malignancy in the past 5 years, except for non-melanoma skin cancer that has undergone potentially curative therapy or in situ cancer, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent",{"count":148,"type":21},[24,25],"This phase I\u002FII trial evaluates the safety and feasibility of early, response-based dose reduction of linvoseltamab in the treatment of patients multiple myeloma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is resistant to three classes of therapeutic agents, including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies (triple-class relapsed\u002Frefractory). Linvoseltamab is a bispecific antibody. Upon administration, linvoseltamab binds to the BCMA protein on cancer cells and the CD3 protein on T cells (a type of immune cell). This generates an immune response that stimulates the T cells to kill the cancer cells. Optimal dosing schedules of linvoseltamab have not yet been determined. Reducing the dosage of linvoseltamab may reduce treatment-related side effects while maintaining long-term disease outcomes.",[28,29],"2026-03-24",{"date":366,"type":34},"2026-03-27",{"date":364,"type":34},{"date":369,"type":21},"2028-06-30",{"name":161,"class":41},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":109},"100542841","phase-1-talquetamab-in-combination-with-iberdomide-and-dexamethasone-for-relapsed-or-refractory-multiple-myeloma-100542841","NCT06348108","Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma","A Phase Ib, Multi-center, Study of Talquetamab in Combination With Iberdomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. Has a prior history of (h\u002Fo) MM (based on International Myeloma Working Group (IMWG) criteria) and now has evidence of relapsed or refractory MM. RRMM of progressive disease as defined by the IMWG 2006 and 2016 criteria (Kumar at al).\n3. Specific criteria for dose escalation and dose expansion:\n\n   1. Phase 1 dose escalation: patients will be required to have TCE RRMM (including a proteasome inhibitor (PI) (≥ 2 cycles or 2 months of treatment), an immunomodulatory drug (IMiD)) (≥ 2 cycles or 2 months of treatment) and a CD38 antibody (≥ 2 cycles or 2 months of treatment) after receiving ≥ 3 prior lines of therapy. Prior BCMA exposure is allowed. (Subjects with discontinued PI\u002FIMiD\u002FCluster of differentiation 38 (CD38) therapy due to severe adverse event after \\\u003C 2 months are allowed)\n   2. Dose expansion cohort: RRMM patients will be lenalidomide refractory, TCE (exposed to IMiD, PI and CD38 antibody therapy (≥ 2 cycles or 2 months of treatment for each) and have received ≥ 2 prior lines of therapy. Prior BCMA targeted therapy is allowed, not required. (Subjects with discontinued PI\u002FIMiD\u002FCD38 therapy due to severe adverse event after \\\u003C 2 months are allowed. Lenalidomide refractory is defined as having evidence of progressive disease on lenalidomide (≥ 10 mg or greater, ≥ 21 days\u002F28) or within 60 days of stopping lenalidomide therapy.)\n4. Has measurable disease defined as at least 1 of the following:\n\n   1. Serum M-protein ≥ 0.5 g\u002FdL (dose escalation) and 1.0 g\u002FdL (dose expansion cohorts)\n   2. Urine M-protein ≥ 200 mg\u002F24 hours\n   3. Serum free light chain (FLC) assay: involved FLC assay ≥ 10 mg\u002FdL (≥ 100 mg\u002FL) AND an abnormal serum FLC ratio (\\\u003C 0.26 or \\> 1.65). (Can be used to fulfill the inclusion criteria of measurable disease in patients who do not have measurable disease by M-protein).\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has adequate baseline organ function, as demonstrated by the following:\n\n   1. Calculated creatinine clearance \\> 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation, Modification of Diet in Renal Disease (MDRD) equation (National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 2015) or as assessed by 24-hour urine collection.\n   2. Serum bilirubin ≤ 1.5 mg\u002FdL, excluding Gilbert's.\n   3. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × institutional upper limit normal (ULN).\n   4. Total serum calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) (treatment of hypercalcemia is allowed and patients may enroll if hypercalcemia returns to WNL with standard treatment).\n7. Has adequate baseline hematologic function, as demonstrated by the following:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (myeloid growth factors must not have been administered within 7 days (14 days for extended 1\u002F2-life products).\n   2. Hemoglobin ≥ 8 g\u002FdL (red blood cell transfusions permitted provided the anemia is disease-related).\n   3. Platelet count ≥ 100 x 10\\^9\u002FL and no platelet transfusions during the 7 days before first dose (without transfusions). (Dose expansion cohorts will be allowed to have platelets counts ≥ 75 x 10\\^9\u002FL with no platelet transfusions during the prior 7 days).\n8. Must have at least 2 negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test result obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second within 24 hours prior to initiating therapy if the patient is a female of childbearing potential (FCBP; defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 24 consecutive months).\n9. Men and women of childbearing potential must agree to not donate sperm and eggs (ova and oocytes) throughout study therapy and for 3 months after the last treatment.\n10. Men and women agree to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 3 months after the last treatment with study treatment.\n\n    1. Women of childbearing potential must agree to 2 methods of reliable birth control simultaneously while receiving study treatment and until 100 days after last dose of study treatment: one highly effective form of contraception (tubal ligation, intrauterine device, hormonal \\[oral, injectable, transdermal patches, vaginal rings or implants\\] or partner's vasectomy, and 1 additional effective contraceptive method (male latex or synthetic condom, diaphragm or cervical cap).\n    2. Males must agree to always use a latex or synthetic condom during any sexual contact with females of reproductive potential.\n11. All patients should be encouraged to be fully vaccinated prior to initiation of therapy including being up-to-date on vaccines against pneumococcus, yearly influenza, Coronavirus disease (COVID) booster(s), and any age appropriate vaccine. Live attenuated vaccines are not allowed while on study treatment or within 4 weeks of starting treatment.\n12. Has provided signed informed consent before initiation of any study-specific procedures or treatment.\n13. Must agree to, and be capable of, adhering to the study visit schedule and other protocol requirements, including follow-up for overall survival.\n\nExclusion Criteria:\n\n1. Has persistent clinically significant toxicities (grade ≥ 2; per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) from previous anticancer therapy (excluding alopecia which is permitted and excluding grades 2 and 3 laboratory abnormalities (including hematologic abnormalities) if participants are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies.\n2. Has NCI CTCAE grade ≥ 3 peripheral neuropathy from any etiology or grade ≥ 2 peripheral neuropathy with pain.\n3. Has received treatment with cytotoxic (alkylators) within 3 weeks, biologic (IMiDs\u002FPIs) within 2 weeks, targeted therapies (monoclonal antibodies) within 4 weeks, chimeric antigen receptor (CAR) T-cell (CAR-T)or autologous stem cell transplant therapy within 3 months or any novel therapy within 5- 1\u002F2 lives of therapy.\n4. Has had radiation therapy within 14 days of first dose of study therapy, unless less than 5% marrow exposure, then no limit.\n5. Has had any prior GPRC5D targeted bispecific antibody therapy or GPRC5D CAR-T therapy or has had previous treatment with Iber.\n6. Has any active or uncontrolled infection including any viral, bacterial or fungal infection; and\u002For HIV, active hepatitis (Hep) C and active Hep B (hepatitis B (HB) surface antigen (HBsAg) (+), HB core antigen (HBcAb) (+) or (+) Hep B deoxyribonucleic acid (DNA) by polymerase chain reaction (pcr), Hep C ribonucleic acid (RNA) (+) by pcr. Patients who have received Intravenous immunoglobulin therapy (IVIG) replacement therapy may have (+) HBcAb results from the IVIG therapy. These patients can enroll if Hep B DNA by pcr test is negative. These patients need to be on antiviral therapy and be monitored for hepatitis B virus (HBV) DNA throughout study therapy per local guidelines and as clinically indicated.\n7. Has an additional active malignancy that may confound the assessment of the study endpoints. If the patient has a past cancer history (active malignancy within 2 years before study entry) with substantial potential for recurrence, this must be discussed with the sponsor\u002Finvestigator before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: nonmelanoma skin cancer and carcinoma in situ (including transitional cell carcinoma, cervical cancer, anal carcinoma, ductal carcinoma in situ (DCIS) and melanoma in situ), any cancer resected with curative intent, low-grade cancer not requiring therapy.\n8. Is pregnant or breast feeding.\n9. Has clinically significant cardiovascular disease including, albeit not limited to:\n\n   1. Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure\n   2. Uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months before study entry\n   3. Uncontrolled hypertension or clinically significant arrhythmias not controlled by medication.\n10. Has active POEMS (polyneuropathy, organomegaly, endocrinopathy\u002Fedema, monoclonal-protein, skin syndrome), amyloid light (AL) amyloidosis, primary plasma cell leukemia or active central nervous system (CNS) or parenchymal\u002Fleptomeningeal myeloma.\n11. Has uncontrolled, clinically significant organ dysfunction that in the opinion of the investigator would put the patient at significant risk for toxicity from study therapy.\n12. Has recent major surgery within 4 weeks or significant gastrointestinal (GI) disease that would interfere with GI absorption of oral medications.\n13. Has a condition, including autoimmune disease, requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before study therapy administration. Inhaled or topical steroids and adrenal replacement doses \\\u003C10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n14. Has received treatment with allogeneic stem cell transplant within 6 months before the first dose of study treatment and if \\> 6 months from allogeneic stem cell transplantation (alloSCT) must be off all immunosuppression and without evidence of active graft-versus-host disease (GVHD).\n15. Uncontrolled epilepsy or new\u002Frecent seizure activity within 6 months of study entry.\n16. Live vaccine administered within 4 weeks prior to study therapy.",{"count":379,"type":21},32,[24],"This phase I trial will evaluate the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is an FDA approved drug that can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug and works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands to reduce inflammation (swelling, heat, redness, and pain) and is used to in helping to treat certain types of cancer including myeloma.",[152,29,197],"2026-03-11",{"date":385,"type":34},"2026-03-13",{"date":387,"type":34},"2025-07-28",{"date":389,"type":21},"2029-07-31",{"name":391,"class":41},"Alfred Chung, MD",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":412},"100526709","phase-2-elranatamab-in-rr-multiple-myeloma-100526709","NCT06138275","Elranatamab in R\u002FR Multiple Myeloma","A Phase 2 Study of Elranatamab as Consolidation After Idecabtagene Vicleucel in Relapsed Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n* Male or female participants age ≥ 18 years\n* The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.\n* Prior diagnosis of MM as defined according to IMWG criteria.\n* Measurable disease of multiple myeloma as defined by at least one of the following prior to idecabtagene vicleucel infusion:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\n  * Serum free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free kappa to serum free kappa light chain ratio (\\\u003C0.26 or \\>1.65)\n* Previously treated relapsed and refractory multiple myeloma following idecabtagene vicleucel as infusion as standard of care who have achieved at least a PR or better per IMWG criteria. Patients will have received idecabtagene per label including after at least 4 prior lines of therapy and relapsed after an immunomodulatory drug (IMiD), a proteasome inhibitor and an Anti-CD38 monoclonal antibody\n* left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gated acquisition scan (MUGA) scan or echocardiogram (ECHO).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000\u002Fmicrolitre (mcL). Use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing.\n  * Platelet count ≥25,000\u002FmcL. Platelet transfusion support is permitted if completed at least 7 days prior to planned start of dosing.\n  * Hemoglobin ≥8 g\u002FdL. Red blood cell transfusion support is permitted if completed at least 7 days prior to planned start of dosing.\n  * Calculated creatinine clearance ≥30 mL\u002Fmin by Cockcroft-Gault equation.\n  * Patient has adequate hepatic function, as evidenced by each of the following:\n\n    * Serum total bilirubin \\\u003C2 mg\u002FdL; and\n    * Serum aspartate transaminase (ALT) and\u002For aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin).\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n\nExclusion Criteria:\n\n* Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.\n* Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).\n* Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:\n\n  * Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);\n  * Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\] or pulmonary embolism);\n  * Prolonged QT syndrome (or triplicate average QTcF \\>470 msec at screening).\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n* Ongoing Grade ≥2 peripheral sensory or motor neuropathy.\n* History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n* Previous treatment with an anti-BCMA (B-cell maturation antigen) bispecific antibody.\n* Pregnant women are excluded from this study because elranatamab is an anti-BCMA bispecific antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.\n\nKnown or suspected hypersensitivity to the study intervention or any of its excipients.\n\nParticipants who are receiving any other investigational agents for this condition (if appropriate only).\n\nLive attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention.\n\nToxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.\n\nOther surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\nPrevious administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).",{"count":379,"type":21},[25],"This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.",[29,220,152],[404],"relapsed\u002Frefractory multiple myeloma",{"date":385,"type":34},{"date":407,"type":34},"2024-03-08",{"date":409,"type":21},"2028-12-01",{"name":411,"class":41},"Massachusetts General Hospital",3,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":109},"100508117","phase-2-iberdomide-daratumumab-carfilzomib-and-dexamethasone-iber-kdd-in-patients-with-relapsedrefractory-multiple-myeloma-100508117","NCT05896228","Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed\u002FRefractory Multiple Myeloma","Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed\u002FRefractory Multiple Myeloma","Iber-KDd","Inclusion Criteria:\n\n1. Patients with histologically confirmed MM with progressive disease according to the IMWG criteria 47 during or within 60 days of their last regimen who have received 1-3 lines of prior therapy (inclusive of a lenalidomide-containing regimen) and have measurable disease within 4 weeks of enrollment based on one of the following:\n\n   * Serum monoclonal protein ≥ 1.0 g\u002FdL\n   * Urine monoclonal protein ≥ 200 mg\u002F24 hour\n   * Involved serum immunoglobulin free light chains (FLC) ≥ 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio.\n\n   Note: Because the primary endpoint is MRD-negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease (e.g., M-spike \\\u003C 1.0 g\u002FdL) may also be enrolled in line with the IMWG MM response criteria 47.\n2. Prior treatment with cluster of differentiation 38 (CD38) -directed therapy is permitted only if all the following are fulfilled:\n\n   * Best response achieved during CD38-directed therapy was ≥ PR.\n   * Patient did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy.\n   * Patient did not discontinue CD38-directed therapy due to a related AE.\n3. Prior treatment with carfilzomib is permitted only if all the following are fulfilled:\n\n   * Best response achieved during carfilzomib-based therapy was ≥ PR.\n   * Patient did not progress while receiving carfilzomib-based therapy or within 60 days of last dose of therapy.\n   * Patient did not discontinue carfilzomib due to a related AE.\n4. Creatinine Clearance (CrCl) ≥60 ml\u002Fmin measured within 4 weeks of enrollment. CrCl can be measured or estimated using Cockcroft-Gault method, Modification of Diet in Renal Disease (MDRD), or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulae.\n5. Age ≥ 18 years at the time of signing the informed consent documentation. Age limit of 75 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 4 weeks of enrollment (Appendix A).\n7. Absolute neutrophil count (ANC) ≥ 1.0 K cells\u002FµL, hemoglobin ≥ 8 g\u002FdL, and platelet count ≥ 50 K platelets\u002FµL measured within 4 weeks of enrollment unless cytopenias are deemed to be due to disease at the discretion of the clinical Investigator. Transfusions and administration of growth factors are permissible.\n8. Adequate hepatic function with bilirubin \\\u003C 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3.0 x ULN measured within 4 weeks of enrollment.\n9. All study participants must be able to tolerate one of the following thromboprophylactic strategies: oral factor Xa inhibitors or low molecular weight heparin or alternative anti-coagulant.\n10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test within 10-14 days and again within 24 hours prior to prescribing of iberdomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, at the same time at least 28 days before she starts taking iberdomide without interruption. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.\n\n    * A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Females who do not meet the above definition of FCBP should be classified as females not of childbearing potential (FNCBP).\n\nExclusion Criteria:\n\n1. Patients receiving concurrent systemic treatment for MM with the following exceptions:\n\n   * Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted.\n   * Patients may receive kyphoplasty\u002Fvertebroplasty for symptomatic vertebral compression fractures.\n   * Bone targeting agents are permitted.\n   * Concurrent or prior treatment with corticosteroids for indications other than MM is permitted.\n   * Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.\n   * Prior MM treatments must be concluded with a washout period of 2 weeks from last dose.\n2. Patients who are refractory to an anti-CD38-directed regimen:\n\n   * Prior anti-CD38-directed therapy and carfilzomib are permitted as long as above inclusion criteria are met.\n3. Patients with plasma cell leukemia.\n4. Patients with Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes syndrome (POEMS syndrome).\n5. Patients with amyloidosis.\n6. Patients with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal within 4 weeks of enrollment.\n\n   Note: FEV1 testing is required for patients suspected of having COPD, and patients must be excluded if FEV1 \\\u003C 50% of predicted normal at any time during the study.\n7. Pregnant or lactating females. Because there is a potential risk for AEs in nursing infants secondary to treatment of the mother with carfilzomib in combination with iberdomide, pregnant or lactating females are excluded from study participation. These potential risks may also apply to other agents used in this study.\n8. Uncontrolled hypertension (ie, systolic blood pressure \\[BP\\] \\> 160 mmHg, diastolic BP \\> 100 mmHg) or diabetes\n9. Patients with active hepatitis B or C infection.\n10. Patient is:\n\n    * Seropositive for human immunodeficiency virus (HIV) (Section 10.3.5.1) within 4 weeks of enrollment.\n    * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]) within 4 weeks of enrollment. Patients with resolved infection (i.e., patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (RT-PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.\n    * Seropositive for hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy).\n\n    For more information regarding the timing and frequency of hepatitis testing, refer to Section 10.3.5.1.\n11. Significant cardiovascular disease with New York Heart Association (NYHA) class III or IV symptoms, symptomatic ischemia, current uncontrolled arrhythmias, screening electrocardiogram (ECG) with corrected QT interval (QTc) of \\> 470 msec within 4 weeks of enrollment, pericardial disease, or myocardial infarction within 4 months prior to enrollment, and left ventricular ejection fraction (EF) \\\u003C 40% as assessed by transthoracic echocardiogram (ECHO) within 4 weeks of enrollment. Current unstable angina as determined by history and physical exam, hypertrophic cardiomyopathy or restrictive cardiomyopathy\n12. Pulmonary hypertension\n13. Has refractory gastrointestinal (GI) disease with refractory nausea\u002Fvomiting, inflammatory bowel disease, or bowel resection that would prevent absorption of oral agents\n14. Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness\u002Fsocial situations that would compromise compliance with study requirements\n15. Significant neuropathy ≥ Grade 3 with pain at baseline\n16. Contraindication to any concomitant medication, including antivirals or anticoagulation\n17. Major surgery within 3 weeks prior to first dose\n18. Prior treatment with iberdomide\n19. For female patients: Patient plans to become pregnant or donate eggs during the Treatment Period and\u002For required period for contraception use post-last dose of study treatment.\n20. For male patients: Patient plans to father a child or donate sperm during the Treatment Period and\u002For required period for contraception use post-last dose of study treatment.\n21. Patients with limited decision-making capacity.","75 Years",{"count":148,"type":21},[25],"The investigators want to find out whether or not giving patients who have relapsed or refractory multiple myeloma (MM) the experimental medication combination iberdomide, carfilzomib, daratumumab, and dexamethasone (Iber-KDd) may produce better results than the current (standard of care) treatments. This study will examine the tolerability and efficacy of this combination therapy for all participants and the ability of this combination therapy to shrink or prevent MM from returning.",[29,197],"2026-03-09",{"date":383,"type":34},{"date":429,"type":34},"2024-02-20",{"date":431,"type":21},"2031-03-01",{"name":433,"class":41},"Benjamin T Diamond, MD",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":109},"100588353","phase-2-dasatinib-and-quercetin-with-car-t-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-100588353","NCT06940297","Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed or refractory multiple myeloma who has had at least 3 prior lines of therapies including a proteasome inhibitor, immunomodulatory drug (IMiD) and anti-CD38 monoclonal antibody (mAb)\n* Ciltacabtagene autoleucel (Carvykti) available for patient\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Life expectancy ≥ 12 weeks\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Platelet count ≥ 50,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n\n  * Note: Patients with Gilbert's syndrome must have a total bilirubin of ≤ 3 x ULN (obtained ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN (obtained ≤ 14 days prior to registration)\n* Alkaline phosphatase ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n\n  * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 30 days after the last dose of study drug\n* Provide written informed consent\n* Willingness to provide mandatory blood and bone marrow specimens for correlative research\n* Willingness to provide mandatory bone marrow cores and\u002For tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis\n* Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.\n\n  * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment\n* Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* Major surgery ≤ 28 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be HIV positive.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, or those currently receiving antiretroviral therapy with good control of HIV, are eligible for this trial\n* Evidence of cardiovascular disease risk, as defined by any of the following:\n\n  * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block\n  * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.\n  * Class III or IV heart failure as defined by the New York Heart Association functional classification system\n  * Uncontrolled hypertension\n  * History of life-threatening ventricular arrhythmias\n  * QTC interval \\[electrocardiogram (ECG)\\] ≥ 450 msec\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Any medical condition that would make participation unduly hazardous\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Live vaccine ≤ 6 weeks prior to registration\n* Has taken a strong inhibitor or inducer of CYP3A4\u002F5, including grapefruit, St. John's Wort or related products ≤ 14 days prior to registration.\n\n  * Note: If required, patients may receive a short course of strong inhibitors or inducers for treatment of symptoms, but dasatinib dose must be adjusted as indicated\n* Known hypersensitivity or allergy to dasatinib or quercetin\n* Patients on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc).\n* On antiplatelet agents (e.g. full dose aspirin, clopidogrel etc.)\n\n  * NOTE: Baby aspirin, if necessary for cardioprotection, will be allowed\n* On quinolone antibiotic therapy for treatment or for prevention of infections products ≤10 days prior to registration",{"count":442,"type":21},44,[25],"This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.",[28,29],"2026-02-04",{"date":448,"type":34},"2026-02-06",{"date":450,"type":34},"2025-06-23",{"date":452,"type":21},"2031-08-15",{"name":454,"class":41},"Mayo Clinic",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":109},"100504381","phase-2-alternate-doses-and-dosing-schedules-of-belantamab-mafodotin-for-treatment-of-triple-class-refractory-multiple-myeloma-100504381","NCT05847569","Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma","Phase II Trial for Evaluation of Alternate Doses and Dosing Schedules of Belantamab Mafodotin in Triple-Class Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2\n* Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined in International Myeloma Working Group (IMWG) criteria, and:\n\n  * If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be \\> 100 days prior to registration to be eligible for the study\n  * Has had disease progression after \\>= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)\n  * Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or bispecific antibody will be allowed to participate in the study\n* Has measurable disease with at least one of the following:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>= 5 g\u002FL)\n  * Urine M-protein \\>= 200 mg\u002F24 h\n  * Serum free light chain (FLC) assay: Involved FLC level \\>= 10 mg\u002FdL (\\>= 100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C 0.26 or \\> 1.65)\n  * Note: Patients with non-secretory disease will be allowed to participate\n* Absolute neutrophil count \\>= 0.75 x 10\\^9\u002FL (=\\\u003C 28 days prior to registration)\n\n  * Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin\n* Hemoglobin \\>= 7.0 g\u002FdL (=\\\u003C 28 days prior to registration)\n\n  * Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin\n* Platelets \\>= 50 x 10\\^9\u002FL (=\\\u003C 28 days prior to registration)\n\n  * Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin\n* Total bilirubin =\\\u003C 2.0 x upper limit of normal (ULN) (=\\\u003C 28 days prior to registration); (total bilirubin \\>= 2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\\u003C 35%)\n* Alanine aminotransferase =\\\u003C 2.5 x ULN (=\\\u003C 28 days prior to registration)\n* Aspartate transaminase =\\\u003C 2.5 x ULN (=\\\u003C 28 days prior to registration)\n* Estimated glomerular filtration rate (eGFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 (=\\\u003C 28 days prior to registration)\n\n  * As calculated by Modification of Diet in Renal Disease (MDRD) formula\n* Spot urine \\[albumin\u002Fcreatinine ratios (spot urine)\\] =\\\u003C 500 mg\u002Fg (56 mg\u002Fmmol) OR urine dipstick negative\u002Ftrace \\[if \\>1+ only eligible if confirmed =\\\u003C 500 mg\u002Fg (56 mg\u002Fmmol) by albumin\u002Fcreatinine ratio (spot urine from first void)\\] (=\\\u003C 28 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only. Both females and males must agree to follow the instructions\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Provide written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol\n* Willingness to provide mandatory blood specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia\n* Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study\n* Systemic active infection requiring treatment\n* Any unresolved toxicity \\>= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2\n* Any major surgery =\\\u003C 4 weeks prior to registration\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures\n* Evidence of active mucosal or internal bleeding\n* Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria\n* Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the prior malignancy has been considered medically stable for \\> 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. NOTE: Participants with curatively treated nonmelanoma skin cancer are allowed without a 2-year restriction.\n* Evidence of cardiovascular risk, including any of the following:\n\n  * Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz type II) or 3rd degree atrioventricular (AV) block\n  * History of myocardial infarction (=\\\u003C 6 months), acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 12 weeks of screening\n  * Class III or IV heart failure as defined by the New York Heart Association functional classification system \\[NYHA, 1994\\]\n  * Uncontrolled hypertension\n* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment\n* Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n\n  * Established anti-retroviral therapy (ART) for at \\>=4 weeks and HIV viral load \\\u003C 400 copies\u002FmL\n  * CD4+ T-cell (CD4+) counts \\>= 350 cells\u002FuL\n  * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections \\\u003C 12 months prior\n  * Note: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant\n* Patients with hepatitis B will be excluded unless the following criteria can be met:\n\n  * If patient's serology shows hepatitis B virus core antibody (HbcAb)+ and hepatitis B surface antigen (HbsAg)-, they must have undetectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening. Patients will be monitored per protocol. Antiviral treatment would be instituted if HBV DNA becomes detectable\n  * If patient's serology shows HBsAg+ at screen or within 3 months prior, patients must have undetectable HBV DNA at screening, must have started highly effective antiviral treatment at least 4 weeks prior to registration, and must have baseline imaging per protocol (patients with cirrhosis are excluded). Patients must remain on antiviral treatment throughout the study. Patients will be monitored per protocol\n  * Note: presence of hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.\n* Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or =\\\u003C 12 weeks prior to first dose of study treatment unless the participant can meet the following criteria:\n\n  * RNA test negative\n  * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period \\>= 4 weeks\n* Current corneal epithelial disease except for mild punctuate keratopathy\n* Participant who received plasmapheresis within =\\\u003C 7 days prior to registration\n* Patients who received prior allogeneic stem cell transplant\n* Participant who received a live or live-attenuated vaccine =\\\u003C 30 days prior to registration. Ok to receive coronavirus disease (COVID) vaccine at any timepoint during protocol treatment\n* Participant is a woman who is pregnant or lactating\n* Participant who plans on wearing contact lenses during treatment with belantamab mafodotin\n\nLifestyle Considerations:\n\nContact lenses are prohibited for participants while they are receiving belantamab mafodotin treatment. Contact lens use may be restarted after belantamab mafodotin treatment is discontinued, provided a qualified eye care specialist confirm there are no other contraindications. Use of bandage contact lenses is allowed for the treatment of corneal epithelial disease as prescribed by an ophthalmologist\u002Feye care professional.\n\nNo other lifestyle restrictions are required for participants in this study.",{"count":216,"type":21},[25],"This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and\u002For does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.",[28,29],{"date":467,"type":34},"2026-02-03",{"date":469,"type":34},"2024-01-04",{"date":471,"type":21},"2034-06-29",{"name":454,"class":41},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":487,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":309},"100510135","phase-2-isatuximab-bela-maf-pom-and-dex-in-relapsedrefractory-multiple-myeloma-100510135","NCT05922501","Isatuximab, Bela Maf, Pom, and Dex in Relapsed\u002FRefractory Multiple Myeloma","A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma","ISABELA","Inclusion Criteria:\n\n* Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).\n* Age ≥ 18 years\n* Measurable disease of multiple myeloma as defined by at least one of the following:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\n  * Involved serum free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free light chain ratio\n* Previously treated relapsed and refractory multiple myeloma:\n* Patients must have received at least one prior line of therapy;\n* Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen); and\n* Disease progression on or within 60 days of completion of last therapy.\n* ANC ≥ 1000\u002FμL. G-CSF is not permitted within 14 days of screening. Patients with ANC \\\u003C1000\u002FµL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from the PI.\n* Platelet count ≥ 75,000\u002FµL. Platelet transfusion is not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula\n* Spot urine (albumin\u002Fcreatinine ratios (spot urine) \\\u003C 500 mg\u002Fg or urine dipstick negative\u002Ftrace.\n* Patient has adequate hepatic function, as evidenced by each of the following:\n* Serum bilirubin values \\\u003C 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and\u002For aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin).\n* Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.\n* All study participants must be registered into the mandatory Pomalyst REMS program and be willing and able to comply with the requirements of the Pomalyst REMS program.\n* Women of childbearing potential (WOCBP) must adhere to the scheduled pregnancy testing as required in the Pomalyst REMS program and agree to use a highly effective method of contraception during the study for 4 months after the last dose of treatment in the study (see Appendix) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period). A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before the first dose of study intervention and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin. Note: non childbearing potential defined as follows (by other than medical reasons):\n\n  * ≥ 45 years of age and has not had menses for \\> 1 year\n  * Patients who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n* A man who is sexually active with a WOCBP (even if they have undergone a successful vasectomy) must agree to use a barrier method of birth control e.g. either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository for 6 months after receiving the last dose of study drug.\n* Male participants must refrain from donating sperm for 6 months after the last dose of study drug.\n* Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).\n\nExclusion Criteria:\n\n* Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.\n* Participant must not use contact lenses while participating in this study.\n* Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.\n* Participants who are receiving any investigational agents.\n* Prior therapy with anti-CD38 monoclonal antibody within six months. No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment.\n* Prior therapy with anti-BCMA therapy.\n* Plasmapheresis within seven days prior to start of study treatment.\n* Primary refractory disease.\n* Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg\u002Fday or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.\n* Pregnancy or lactation or planned lactation (breastfeeding).\n* Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥ 3 years. Patients who are free of disease \\\u003C 3 years may enroll after discussion with and approval of the PI. Exceptions include the following (i.e. the following are eligible to participate):\n\n  * Basal or squamous cell carcinoma of the skin\n  * Carcinoma in situ of the cervix\n  * Ductal carcinoma in situ of the breast\n  * Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance\n* Patients with active plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.\n* Seropositive for HIV infection\n* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]; see exception below). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened for hepatitis B virus (HBV) DNA levels. Those with positive HBV viral load will be excluded. Exception: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need testing for HBV DNA.\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).\n* Peripheral neuropathy ≥ grade 2 despite supportive therapy.\n* Hypersensitivity to isatuximab, belantamab mafodotin, pomalidomide, or dexamethasone, such as Stevens-Johnson syndrome. Rash to immunomodulatory drug that can be medically managed is allowed.\n* Allogeneic stem cell transplant \\\u003C12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD).\n* Autologous stem cell transplant \\\u003C6 months prior to start of treatment\n* Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:\n\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n  * Unstable angina\n  * Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block\n  * Recent (within the preceding 6 months) myocardial infarction or stroke\n  * Uncontrolled hypertension\n  * Diabetes mellitus with \\> 2 episodes of ketoacidosis in the preceding 12 months\n  * Chronic obstructive pulmonary disease (COPD) requiring \\> 2 hospitalizations in the preceding 12 months.\n  * Unstable liver or biliary disease\n  * Active bacterial, viral, or fungal infection\n* Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.\n* Major surgery within 4 weeks prior to C1D1.\n* Live or live-attenuated vaccine within 30 days prior to C1D1.\n* Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.",{"count":482,"type":21},50,[25],"The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.",[486,29,152],"Relapsed Cancer",[488,152,489],"Relapsed\u002FRefractory","Relapsed and Refractory","2026-01-12",{"date":492,"type":34},"2026-01-14",{"date":494,"type":34},"2024-05-31",{"date":496,"type":21},"2030-12-31",{"name":411,"class":41},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":109},"100564328","phase-2-mezigdomide-carfilzomib-and-dexamethasone-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-in-patients-with-extramedullary-disease-100564328","NCT06627751","Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease","Phase II Clinical Trial of Mezigdomide\u002FCarfilzomib\u002FDexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* RRMM patients with one or more prior lines of therapy with at least one ES or PS lesion that is accessible to a biopsy. Accessibility will be assessed by the MM tumor board\n* Measurable disease meeting at least one of the following:\n\n  * Serum M-protein ≥1 g\u002FdL\n  * Urine M-protein ≥200 mg\u002F24 h\n  * Serum FLC assay: involved FLC level ≥10 mg\u002FdL provided serum FLC ratio is abnormal\n  * Up to 10 patients without measurable disease can be enrolled but screening imaging and\u002For bone marrow biopsy have to confirm RRMM. Follow-up response assessment will be performed with imaging using RECIST 1.1 and Deauville Criteria and bone marrow biopsies\n* Absolute neutrophil count: ≥ 1 x 10\\^9\u002FL\n* Platelets: ≥ 75 x 10\\^9\u002FL\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 x ULN\n* Renal function: Estimated creatinine clearance ≥ 30 mL\u002Fmin (Cockroft-Gault)\n* Adequate cardiac pump function with a left ventricular ejection fraction of ≥ 40%\n* Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for at least 28 days after the last dose of mezigdomide or 6 months after the last dose of carfilzomib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Male patients (non-vasectomized) must agree to use contraception during the treatment period and for at least 28 days after the last dose of mezigdomide or 3 months after the last dose of carfilzomib and refrain from donating sperm during this period\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participant has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥ grade 3 rash during prior thalidomide, lenalidomide, or pomalidomide therapy), carfilzomib or dexamethasone, any cereblon E3 ligase modulators (CELMoD) agents, or the excipients contained in the formulations, or participant has any contraindications per local prescribing information\n* Administration of strong CYP3A modulators or proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study intervention\n* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis\n* Patient has evidence of mucosal or internal bleeding and\u002For is platelet transfusion refractory\n* Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient or would adversely affect his\u002Fher participation in this study\n* Known active infection requiring parenteral or oral anti-infective treatment within the past 14 days\n* Participant has a history of prior malignancy other than MM, except if the participant has been free of disease for ≥ 3 years or the participant had 1 of the following noninvasive malignancies treated with curative intent without known recurrence:\n\n  * Basal or squamous cell carcinoma of the skin\n  * Carcinoma in situ of the cervix or breast\n  * Stage 1 bladder cancer\n  * Incidental histological findings of localized prostate cancer such as tumor stage 1a or 1b (T1a or T1b) using the tumor, nodes, and metastasis (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent\n* Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to patient registration\n* Pregnant or breast-feeding females\n* Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation\n* Known active HIV or hepatitis B or C viral infection\n* Known history of HIV infection\n* Systemic amyloidosis or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \\[M-protein\\] and skin changes)\n* Prior peripheral stem cell transplant within 12 weeks of study enrollment\n* Radiotherapy within 14 days prior to cycle 1 day 1. However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy\n* Known intolerance to steroid therapy\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Carfilzomib-refractory in the most recent line of therapy\n* Prior treatment with mezigdomide\n* Contraindication against conscious sedation\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":506,"type":21},28,[25],"This phase II trial studies how well mezigdomide\u002Fcarfilzomib\u002Fdexamethasone (MeziKD) works in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and have tumors from myeloma cells outside the bone marrow in the soft tissues or organs of the body (extramedullary disease \\[EMD\\]). Mezigdomide blocks important processes in myeloma cells and may lead to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a type of corticosteroid and is used to kill myeloma cells. It is used with other drugs to treat multiple myeloma. Giving MeziKD may kill more cancer cells in patients with relapsed\u002Frefractory multiple myeloma (RRMM) with EMD.",[510,28,29],"Extramedullary Disease in Multiple Myeloma","2026-01-09",{"date":490,"type":34},{"date":514,"type":34},"2025-05-01",{"date":516,"type":21},"2030-05-01",{"name":330,"class":41},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":109},"100600135","phase-1-cilta-talq-fusion-study-a-phase-1b-study-of-talquetamab-bridging-therapy-followed-by-ciltacabtagene-autoleucel-in-patients-with-relapsedrefractory-multiple-myeloma-100600135","NCT07093554","Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.\n3. Have measurable disease, defined as:\n\n   1. Serum M-protein level ≥ 1.0 g\u002FdL, or\n   2. Urine M-protein level ≥ 200 mg\u002F24 hours, or\n   3. In patients without a measurable M-protein, an involved light chain level ≥ 10 mg\u002FdL and an abnormal free light chain ratio.\n4. Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).\n5. Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information.\n6. Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.\n8. Have the following clinical laboratory values at screening:\n\n   Adequate bone marrow function:\n\n   Hemoglobin\\* ≥ 8.0 g\u002FdL; Absolute Neutrophil Count\\* ≥ 1,000\u002FmcL; Absolute Lymphocyte Count\\* ≥ 200\u002FmcL; Platelets\\* ≥ 25,000\u002Fmm\\^3\n\n   \\*Transfusion and growth factor support within 72 hours allowed.\n\n   Adequate hepatic function:\n\n   Total Bilirubin \\\u003C 2 mg\u002FdL; Aspartate aminotransferase (Serum Glutamic Oxaloacetic Transaminase)\u002FAlanine Aminotransferase \\\u003C 5 times institutional upper limit\n\n   Adequate renal function:\n\n   Creatinine Clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above institutional normal\n9. Female patients must meet one of the following:\n\n   1. Postmenopausal for at least one year before the screening visit, or\n   2. Surgically sterile, or\n   3. If they are of childbearing potential:\n\n   i. Agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of the study drug, AND ii. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or iii. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n10. Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR\n    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Prior treatment:\n\n   1. Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.\n   2. Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.\n   3. Use of talquetamab prior to enrollment.\n   4. Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and\u002For monoclonal antibodies.\n   5. Prior allogeneic stem cell transplant at any time.\n   6. Autologous stem cell transplant within 2 months of date of enrollment.\n   7. High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date.\n   8. Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date .\n   9. Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.\n   10. A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date .\n   11. Radiation therapy within 7 days of the enrollment date.\n2. No ongoing Grade ≥ 3 non-hematological adverse events from prior therapy.\n3. Active central nervous system (CNS) involvement.\n4. Have plasma cell leukemia (PCL).\n5. Have unmeasurable disease (oligosecretory or non-secretory myeloma).\n6. Have concomitant AL amyloidosis.\n7. Patients with severe cardiac disease.\n\n   1. Active heart disease with New York Heart Association class III or IV congestive heart failure.\n   2. History of myocardial infarction, unstable angina, placement of drug-eluting or metallic stent, coronary artery bypass graft in the last ≤ 6 months.\n   3. Ejection fraction ≤ 40% on transthoracic echocardiography.\n   4. Severe non-ischemic cardiomyopathy.\n8. Patients with pulmonary dysfunction requiring continuous supplemental oxygen ≥ 2L\u002Fminute.\n9. Any serious medical condition such as:\n\n   1. Disabling neurological or psychiatric conditions, including altered mental status, dementia, or any condition that could preclude the use of high-dose steroids and\u002For accurate assessment of neurotoxicity.\n   2. Any condition that could impair the ability of the subject to receive any of the study drugs.\n10. Infections:\n\n    1. No new uncontrolled clinically significant bacterial, viral or fungal infections.\n    2. HIV-positive patients on combination antiretroviral therapy are not eligible.\n11. Pregnant women are excluded from this study because talquetamab and cilta-cel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with talquetamab, breastfeeding should be discontinued if the mother is treated with talquetamab.",{"count":525,"type":21},31,[24],"This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).",[220,29],[530,344,29,220],"Bispecific Antibody","2025-12-30",{"date":533,"type":34},"2026-01-05",{"date":535,"type":34},"2025-12-02",{"date":537,"type":21},"2028-01-01",{"name":352,"class":41},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":412},"100555935","phase-1-elotuzumab--iberdomide--dexamethasone-post-ide-cel-in-rrmm-100555935","NCT06518551","Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM","A Phase I\u002FII Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Previously diagnosed with MM based on standard IMWG criteria\n* Patient has given voluntary written informed consent before any study-related procedures not part of normal medical care are performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.\n* Patient who has been treated with at least 4 prior lines of anti-myeloma treatment including immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.\n* In addition, to at least 4 prior lines of anti-myeloma treatment, patient has received ide-cel in accordance with the FDA approved US Prescribing Information and has achieved at least a partial response, and is within 90 days of infusion\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Screening Laboratory evaluations within the following parameters\n\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FdL (1.0 x 109\u002FL) (Growth factors cannot be used more recently than 7 days prior to initiation of therapy)\n  * Platelet count ≥ 75,000 cells\u002FdL (75 x 109\u002FL) (without transfusions during the 7 days prior to initiation of therapy)\n  * Hemoglobin ≥ 8.0 g\u002FdL (RBC transfusions are permitted)\n  * Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * AST or ALT ≤ 3x ULN\n  * Creatinine clearance ≥ 30 ml\u002Fmin according to the Cockroft-Gault formula:\n\n    * Female CrCl = \\[(140 - age in years) x weight in kg x 0.85\\] \u002F \\[72 x serum creatinine in mg\u002FdL\\]\n    * Male CrCl = \\[(140 - age in years) x weight in kg x 1.00\\] \u002F \\[72 x serum creatinine in mg\u002FdL\\]\n* Age ≥18 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n* A Female of childbearing potential (FCBP) must:\n\n  * Have two negative pregnancy tests before enrollment and randomization into the clinical studies and prior to each re-supply of study drug during the clinical studies based on the frequency outlined in the Pregnancy Prevention Plan (PPP, Appendix D).\n  * Sexually active FCBP must agree to use protocol-specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.\n* Sexually active males (including those who have had a vasectomy) must agree to use protocol specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.\n* All participants (male and female with or without childbearing potential) must agree to abstain from donating blood products for at least 28 days after the last dose of study drug and semen or sperm while taking study drug and for at least 28 days after the last dose of study drug.\n\nExclusion Criteria\n\n* Prior exposure to Iberdomide\n* Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.\n* Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy\n* Known central nervous system involvement.\n* Systemic treatment, within 14 days before the first dose of treatment, with strong CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin, fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine)\n* Any medical or psychiatric illness\u002Fsocial situation that in the Investigator's opinion, would impose excessive risk to the patient, would adversely affect his\u002Fher participating in this study or would limit compliance with study requirements.\n* Currently active graft versus host disease of any stage or grade after allogeneic stem cell transplantation\n* Prior major surgical procedure or radiation therapy within 14 days of initiation of therapy.\n\n  * Those who require a limited course of radiation for management of bone pain more than 14 days out from initiation of therapy are not excluded\n* Any active, or uncontrolled cardiovascular conditions, including but not limited to uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction within the past 6 months.\n* The following therapies within the stated time frames prior to initiation of therapy:\n\n  * Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 21 days (42 days for nitrosoureas).\n  * The use of live vaccines within 30 days.\n  * IMiDs or proteasome inhibitors within 14 days.\n  * Other investigational therapies and\u002For monoclonal antibodies within 4 weeks.\n  * Prior peripheral stem cell transplant within 12 weeks.\n  * Prior allogeneic stem cell transplantation with active graft-versus-host-disease.\n* Those who require a limited course of daily requirement for corticosteroids (equivalent to \\>10 mg\u002Fday prednisone, though \\>10mg\u002Fday is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy. Inhalation corticosteroids are exempt from this criterion.\n\n  * Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy\n* Concurrent symptomatic amyloidosis or plasma cell leukemia\n* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)\n* Infection requiring systemic antibiotic therapy or other serious infection within 7 days of starting therapy.\n\n  * Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection are eligible.\n* Known seropositive for active viral infection with human immunodeficiency virus (HIV) hepatitis B (HBV) or hepatitis C viral (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded\n* Female patients who are pregnant or lactating.\n* Participants who are receiving any other investigational agents for any indication\n* History of erythema multiforme or severe hypersensitivity to prior IMiD's® or those who have a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Inability to tolerate thromboprophylaxis\n* Failure to have fully recovered (≤ Grade 2 according to CTCAE v 5) from the reversible effects of prior chemotherapy",{"count":547,"type":21},49,[24,25],"The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma.\n\nThe names of the study drugs involved in this study are:\n\n* Iberdomide (a type of cereblon E3 ligase modulator)\n* Elotuzumab (a type of monoclonal antibody)\n* Dexamethasone (a type of steroid)",[551,152,29],"Myeloma",[551,152,29,197,553,282],"Relapsed and Refractory Multiple Myeloma","2025-12-04",{"date":556,"type":34},"2025-12-11",{"date":558,"type":34},"2024-11-01",{"date":560,"type":21},"2034-12-31",{"name":562,"class":41},"Omar Nadeem, MD"]