[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-in-relapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-in-relapse":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,53,78,105,130,151,180,201,229,252,292,317,342,364,395,422,445,473,500,525,542,568,588,610,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100642899","phase-2-a-study-of-elranatamab-outpatient-administration-in-patients-with-relapsedrefractory-multiple-myeloma-100642899",false,"NCT07637578","A Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma (CORE-MM)","CORE-MM","Inclusion Criteria:\n\n1. Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses\n2. At least 18 years-of-age at the time of signature of the ICF\n3. Has documented diagnosis of MM according to IMWG diagnostic criteria\n4. Measurable disease at screening, as assessed by local laboratory, defined by any of the following:\n\n   1. Serum M-protein level ≥0.5 g\u002FdL\n   2. Urine M-protein level ≥200 mg\u002F24 hours\n   3. Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda FLC ratio\n   4. For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)\n5. Relapsed and\u002For refractory MM received ≥1 prior line of therapy and must have been exposed to both lenalidomide and an anti-CD38 monoclonal antibody (in the same or separate prior lines)\n6. ECOG Performance Status score of 0 or 1\n7. Human immunodeficiency virus (HIV)-positive participants are eligible if they meet all of the following:\n\n   1. No detectable viral load (i.e., \\\u003C50 copies\u002FmL) at screening\n   2. CD4+ count \\>300 cells\u002Fmm3 at screening\n   3. No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 6 months of screening\n   4. Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance\u002Fprogression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. HAART that could interfere with study treatment is excluded (consult the Medical Monitor for a review of medications prior to enrollment, if needed).\n8. Adequate organ function, defined as follows:\n\n   1. Hemoglobin (Hgb) ≥8 g\u002FdL (≥5 mmol\u002FL; without prior red blood cell \\[RBC\\] transfusion within 7 days before laboratory testing; recombinant human erythropoietin use is permitted)\n   2. Platelets \\>50 x109\u002FL\n   3. Absolute neutrophil count (ANC) ≥10.x109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G-CSF)\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5xupper limit of normal (ULN)\n   5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin based on Modified Diet in Renal Disease (MDRD) 4-variable formula calculation or creatinine clearance measured by 24-hour urine collection\n   6. Total bilirubin \\\u003C1.5xULN (isolated total bilirubin) ≥1.5xULN with conjugated \\[direct\\] bilirubin \\\u003C1.5xULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias)\n   7. Corrected serum calcium ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Participants must be able and willing to receive prophylaxis for Varicella zoster virus (VZV) and Pneumocystis jirovecii pneumonia (PJP) as follows:\n\n   1. VZV prophylaxis (e.g. acyclovir or valacyclovir) must be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n   2. PJP prophylaxis must likewise be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n10. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n11. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception. R\n12. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n13. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n14. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n\nExclusion Criteria:\n\n1. History of antitumor therapy as follows, before the first dose of study drug\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.\n   2. Monoclonal antibody treatment for MM within 21 days.\n   3. Cytotoxic therapy within 21 days.\n   4. PI therapy within 14 days.\n   5. Immunomodulatory agent therapy within 7 days.\n   6. Radiotherapy within 14 days or focal radiation within 7 days.\n   7. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \\[CAR\\]-T cells) ≤12 weeks before the first dose of study drug\n2. Has received any of the following:\n\n   1. Packed red blood cells within the last 7 days prior to dosing\n   2. Platelet transfusions within the last 7 days prior to dosing\n   3. Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study\n3. History of Grade ≥3 CRS or ICANS with prior therapies.\n4. Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.\n5. Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:\n\n   a. Malignancies treated within the last 12 months and considered at very low risk for recurrence: i. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS).\n\n   ii. Skin cancer (non-melanoma or melanoma). iii. Noninvasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.\n\n   v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment).\n\n   b. Other malignancy that is considered at minimal risk of recurrence. In the event of any questions, consult with the Medical Monitor prior to enrolling a participant.\n6. Has active autoimmune disease or documented history autoimmune disease with exception of vitiligo, type I diabetes mellitus, or prior autoimmune thyroiditis currently euthyroid based on symptoms and labs.\n7. Has active plasma cell leukemia (≥20% peripheral blood plasma cells and ≥2.0×109\u002FL plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.\n8. Any of the following cardiac criteria currently or within the last 6 months:\n\n   1. Have documented major electrocardiogram (ECG) abnormalities which are clinically significant at the Investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle-branch blocks, ventricular hypertrophy, or recent myocardial infarction or a mean QTc of \\>470 ms \\[calculated using Fridericia's Correction, confirmed by triplicate ECG\\])\n   2. Cardiac function: left ventricular ejection fraction (LVEF) assessed by ECHO or MUGA \\\u003C45% (evaluation based on institutional lower limit of normal) and the patient has a significant cardiac history, or the investigator suspects ongoing cardiac pathology\n   3. Have the presence of cardiac disease, including a myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III-IV congestive heart failure, aneurysm of major vessels or heart, uncontrolled hypertension.\n   4. Overall cardiac ineligibility determined by the Investigator based on medical history and clinically indicated evaluations\n9. Any significant neurologic or psychiatric conditions diagnosed and\u002For ongoing in the last 6 months prior to anticipated treatment start date including but not limited to severe brain injury, stroke, intracranial hemorrhage, seizure, dementia, or Parkinson's disease. Participants with a history of uncontrolled epilepsy requiring anticonvulsants are excluded if therapy not stable within 6 months prior to enrollment.\n10. Active central nervous system (CNS) multiple myeloma involvement.\n11. Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.\n12. Has hepatitis B infection (i.e., HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. See Section 7.4.7 for further required assessments.\n13. Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n14. Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 4 months after the last administration of study treatment.\n15. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.\n16. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n17. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.","ALL","18 Years",{"count":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.",[28,29,30,31],"Multiple Myeloma (MM)","Multiple Myeloma Refractory","Multiple Myeloma in Relapse","Multiple Myeloma",[31,33,34,35,36,37,38,39,40],"MM","RRMM","Relapsed multiple myeloma","Refractory multiple myeloma","Relapsed or refractory multiple myeloma","Elranatamab","Tocilizumab","T-cell engager","NOT_YET_RECRUITING","2026-06-09",{"date":44,"type":45},"2026-06-11","ACTUAL",{"date":47,"type":22},"2026-08",{"date":49,"type":22},"2030-02",{"name":51,"class":52},"SCRI Development Innovations, LLC","OTHER",{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100628051","phase-1-study-of-the-safety-and-usefulness-of-liposomal-curcumin-in-multiple-myeloma-100628051","NCT07456605","Study of the Safety and Usefulness of Liposomal Curcumin in Multiple Myeloma","Phase I Study of Safety and Efficacy of Liposomal Curcumin in Relapsed Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Must be able to understand and voluntarily sign an informed consent form (ICF).\n* Must be ≥ 18 years of age at the time of signing the ICF\n* Must be able to adhere to the study visit schedule and other protocol requirements.\n* Relapsed and\u002For refractory MM with:\n* Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). OR Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).\n* Previously undergone treatment with at least one immunomodulatory drug (lenalidomide or pomalidomide), one proteasome inhibitor (bortezomib, ixazomib, carfilzomib) and one anti-CD38 drug (daratumumab or isatuximab). These drugs could have been used in separate regimens or in combination.\n* No effective standard of care options available\n* Patients with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:\n* transplant was \\> 12 weeks prior to study enrolment\n* no active infection\n* Patients with measurable disease defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to start of study drug):\n* Serum M-protein ≥ 0.5 g\u002Fdl (≥ 5 g\u002Fl)\n* Urine M-protein ≥ 200 mg\u002F24 h\n* 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)\n* If the serum protein electrophoresis is unreliable for routine M-protein measurement, quantitative immunoglobulin levels on nephelometry or turbidometry will be followed.\n* Must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.\n* Females of child-bearing potential (FCBP) must have a negative serum pregnancy test and must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described.\n* Men with a female partner of childbearing potential must agree to use effective contraception from the time of first dose of study until 90 days after the last dose of study treatment to allow for clearance of any altered sperm.\n* Able to take oral medications\n* All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5) must be ≤Grade 1 at the time of enrollment except for alopecia or be deemed to be irreversible (for example, steroid induced cataracts or peripheral neuropathy).\n* The following laboratory results must be met within 7 days of first study drug administration:\n* Absolute neutrophil count (ANC) \\>1000 cells\u002FdL (1.0 x 10\\^9\u002FL). Growth factors cannot be given within 7 days of study drug administration.\n* Serum AST and ALT ≤ 3 x upper limit of normal (ULN).\n* Creatinine clearance ≥ 20 mL\u002Fmin either directly measured via 24-hour urine collection or calculated using Cockroft-Gault\n* Platelet count ≥ 50 x 109\u002FL. For patients with \\> 50% myeloma involvement in the marrow, a platelet count of ≥30 x 109\u002FL is allowed. Patients may not have received a platelet transfusion within 72 hours prior to the platelet count used for eligibility\n* Hemoglobin ≥ 80 g\u002FL. Patients may receive red blood cell (RBC) transfusions in accordance with institutional guidelines to meet this criterion. Patients may not have received a red blood cell (RBC) transfusion within 72 hours prior to the hemoglobin result used for eligibility; use of growth factors is allowed.\n* Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease.\n* Albumin ≥ 2.0 g\u002FdL (20 g\u002FL).\n* Calcium \\\u003C1.2xULN.\n\nExclusion Criteria:\n\n* Known history of clinically active amyloidosis, POEMS syndrome, or patients with plasma cell leukemia defined as circulating plasma cell count exceeding 500\u002FuL or 5% of the peripheral blood white cells at the time of screening\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with patient's safety, obtaining informed consent or compliance to the study procedures.\n* Pregnant or lactating females.\n* Patients with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the patient's illness. The patient must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years. The following are allowed:\n* Adequately treated in situ carcinoma of the cervix uteri or the breast;\n* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n* In situ malignancy;\n* Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen levels off treatment;\n* Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.\n* Evidence of cardiovascular risk including any of the following:\n* QTc interval ≥ 470 msecs.\n* Evidence of current clinically significant uncontrolled arrhythmias; including clinically significant ECG abnormalities; including 2nd degree (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 six 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* Ejection fraction \\\u003C40% as determined by echocardiogram\n* Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Presence of hepatitis B surface antigen (HBsAg) or positive HBV PCR test at screening or within 3 months prior to first dose of study treatment. Participants with positive hepatitis B core antibody (HBcAb) can be enrolled, only if confirmatory negative Hepatitis B DNA is obtained AND patient is on hepatitis B prophylaxis (e.g. tenofovir or entecavir) before first dose of study drugs. Presence of isolated Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing. Patients with HIV with detectable viral load or with AIDS-defining features or illnesses will be excluded.\n* Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).\n* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease).\n* Current or past history of clinically significant CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM\n* Note that patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.\n* Note that patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed.\n* Known active infection requiring treatment.\n* Receiving systemic immunosuppressive medications (including, but not limited to, azathioprine, methotrexate, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment \\\u003C10mg\u002Fday prednisone or equivalent within 2 weeks. Inhaled corticosteroids for respiratory diseases are allowed.\n* Evidence of active mucosal or internal bleeding.\n* Significant urinary outflow obstruction\n* Radiotherapy or systemic therapy (standard or biologic anticancer agent) within 14 days of initiation of study drug treatment.\n* Use of an investigational drug within 21 days or five half-lives, whichever is shorter, preceding the first dose of study drug.\n* Major surgery within 28 days\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to liposomal curcumin.",{"count":61,"type":22},20,[63],"PHASE1","The purpose of this study is to test the safety of in investigational drug called Liposomal curcumin (LipoCurc) and to find the highest dose that can be given without causing very severe side effects.\n\nTo do this participants are given LipoCurc and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of LipoCurc. Participants joining this study later on will get higher doses of LipoCurc than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.",[29,30],[67],"Liposomal Curcumin","RECRUITING",{"date":70,"type":45},"2026-06-12",{"date":72,"type":45},"2026-02-27",{"date":74,"type":22},"2028-03-02",{"name":76,"class":52},"University Health Network, Toronto",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":77},"100608325","phase-1-recombinant-human-il-7-nt-i7-in-relapsedrefractory-multiple-myeloma-following-bcma-car-t-therapy-cilta-cel-100608325","NCT07200089","Recombinant Human IL-7 (NT-I7) in Relapsed\u002FRefractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)","A Double-blind, Placebo-controlled Phase Ib Study Evaluating the Safety and Toxicity of Recombinant Human IL-7 (NT-I7) in Relapsed\u002FRefractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma with measurable disease by IMWG criteria.\n* Eligible for standard of care, FDA-approved BCMA CAR-T cell therapy with ciltacabtagene autoleucel.\n\n  * Patients enrolling in the dose escalation stage must have received at least two prior lines of treatment and be penta-drug exposed (i.e. exposure to at least 5 active anti-myeloma drugs, excluding corticosteroids and melphalan and including, at minimum, a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody).\n* Life expectancy ≥ 12 weeks per assessment from the enrolling physician.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry until 90 days after completion of NT-I7 therapy\u002Fplacebo (corresponding to Day 125 post CAR-T). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received prior BCMA-directed therapy.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving or have received any other investigational agents within 14 days prior to CAR-T infusion.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7or other agents used in the study.\n* Uncontrolled intercurrent illness including but not limited to: ongoing or active infection (bacterial, fungal, viral, or tuberculosis, including known hepatitis A, B, or C, or HIV (testing not required)), symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia (except well-controlled atrial fibrillation). Patients with a 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 Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting CAR-T therapy.\n* Receipt of live, attenuated vaccine within 30 days prior to first day of treatment.\n* Had an allogeneic tissue\u002Fsolid organ transplant or allogeneic stem cell transplant.\n* Not able to receive intramuscular therapy.\n* Prior history of T cell malignancy.\n* Prior history of congenital immunodeficiency syndrome.\n* Prior history of autoimmune disease with significant disease activity in the past 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sézary syndrome, vasculitis or glomerulonephritis, Bell's palsy, Guillain-Barré syndrome, or multiple sclerosis.\n* Prior history of plasma cell leukemia, systemic amyloidosis, POEMS syndrome, or multiple myeloma with CNS involvement.\n* Planning to start maintenance therapy prior to Day 100 post-CAR-T therapy.\n* A history of clinically significant pulmonary disorders, such as severe asthma, severe COPD, restrictive lung disease, symptomatic pulmonary embolism within 3 months prior to study enrollment, or active or prior interstitial lung disease\u002Fpneumonitis.",{"count":86,"type":22},52,[63],"CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown.\n\nThis is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.",[31,30,90],"Multiple Myeloma, Refractory",[92,93,94,95],"Cytokines","Interleukin-7","Cellular therapy","Chimeric antigen receptor T cell therapy","2026-06-07",{"date":98,"type":45},"2026-06-10",{"date":100,"type":45},"2026-06-05",{"date":102,"type":22},"2028-12-31",{"name":104,"class":52},"Washington University School of Medicine",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100607655","phase-4-self-administered-subcutaneous-daratumumab-in-patients-with-multiple-myeloma-100607655","NCT07191379","Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma","Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study","SCILLA","Inclusion Criteria:\n\n* Diagnosed with MM\n* Initiating treatment with SC daratumumab\n* Able to read and understand the Danish language\n* Are considered suitable for self-administration of SC daratumumab at home (in the opinion of the healthcare professional)\n* Willing and able to complete questionnaires and participate in an interview\n\nExclusion Criteria:\n\n* Resident on an unbridged island\n* Receiving co-treatment with other anti-myeloma treatments necessitating hospitals visits on days of home administration\n* Anything related to their ability to self-administer SC daratumumab at home e.g. physical inabilities or cognitive impairment",{"count":114,"type":22},50,[116],"PHASE4","The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.\n\nAt inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home\u002Fhospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.",[30],[120,121,31],"Treatment at home","Daratumumab","2026-06-03",{"date":100,"type":45},{"date":125,"type":22},"2026-08-01",{"date":127,"type":22},"2028-01-01",{"name":129,"class":52},"Odense University Hospital",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":77},"100579336","phase-2-hcmtmm2401-ph2-study-of-selinexor--bispecific-antibody-for-rrmm-100579336","NCT06822972","HCMT\u002FMM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM","A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of informed consent.\n2. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n4. A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.\n5. All patients must meet criteria for and will receive teclistamab, elranatamab or talquetamab, as per approved label dosing.\n6. Patients who have had CRS\u002FICANS from bispecific antibody must have complete resolution of CRS\u002FICANS before initiation of SEL\n7. Measurable disease as defined by at least one of the following:\n\n   * Serum monoclonal (M) protein ≥1.0 g\u002Fdl by protein electrophoresis\n   * \\>200 mg of M protein in the urine on 24 hour electrophoresis\n   * Serum immunoglobulin free light chain ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n   * Measurable plasmacytoma\n8. Adequate hepatic function measured on labs collected within 28 days of C1D1:\n\n   * Total bilirubin \\\u003C1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \\\u003C3 × ULN), and\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to \\\u003C2.5 × ULN.\n9. Adequate renal function measured on labs collected within 28 days of C1D1. Adequacy will be determined by creatinine clearance with values of ≥ 15 mL\u002Fmin meeting inclusion criteria. Creatinine Clearance will be calculated using the Cockcroft and Gault formula \\[(140 - Age) x Mass (kg)\u002F (72 x creatinine mg\u002FdL); multiply by 0.85 if female\\] (Cockcroft 1976).\n10. Adequate hematopoietic function measured on labs collected within 7 days of C1D1:\n\n    * Absolute neutrophil count ≥1500\u002Fmm3\n    * Hemoglobin ≥8.5 g\u002FdL\n    * Platelet count ≥100,000\u002Fmm3 (patients for whom \\\u003C50% of bone marrow nucleated cells are plasma cells) or ≥50,000\u002Fmm3 (patients for whom ≥50% of bone marrow nucleated cells are plasma cells)\n    * Note 1: Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (e.g., eltrombopag, romiplostim, interleukin-11) are eligible.\n    * Note 2: Patients must have at least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment. However, patients may receive RBC and\u002For platelet transfusions as clinically indicated per institutional guidelines during the study.\n11. Patients who are able to become pregnant must have a negative serum pregnancy test at screening.\n12. All patients who could become pregnant or could father a child must use highly effective methods of contraception throughout the study and for 5 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 9.3.1.\n13. Female patients must agree not to donate egg during the study treatment period and\u002For up to 90 days after the last dose of Selinexor. Male patients must agree not to donate sperm during the study treatment period and\u002For up to 90 days after the last dose of Selinexor.\n\nExclusion Criteria:\n\n1. Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.\n2. Patients with any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection) that is likely to interfere with study procedures.\n3. Patients with any uncontrolled active infection requiring medical or surgical management within 1 week prior to Cycle 1 Day 1 (C1D1). Note: Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are eligible.\n4. Females who are pregnant or breastfeeding females.\n5. Patients with active, unstable cardiovascular function, as indicated by the presence of any of the following:\n\n   * Symptomatic ischemia\n   * Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmics); note: patients with first degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block are eligible\n   * Congestive heart failure of New York Heart Association Class ≥3\n   * Known left ventricular ejection fraction \\\u003C40%\n   * Myocardial infarction within 3 months prior to C1D1.\n6. Patients with well controlled chronic viral hepatitis and\u002For Human Immunodeficiency Virus can be considered for the study if they meet any of the following conditions:\n\n   * Patients with active hepatitis B virus (Hep B) who have been on antiviral therapy for hepatitis B for \\>8 weeks and whose viral load is \\\u003C100 IU\u002Fml prior to first dose of trial treatment\n   * Patients with treated or untreated hepatitis C virus (HCV) and successfully treated and \"cured\" HCV\n   * Patients with Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts ≥ 350 cells\u002FµL and no history of AIDS-defining opportunistic infections in the last year\n7. Patients who still have any grade of CRS\u002FICANS at 5 (± 2) days of administration of the first full treatment dose of bispecific antibody treatment will be excluded\n8. Patients with any active gastrointestinal dysfunction interfering with their ability to swallow tablets or any active gastrointestinal dysfunction that could interfere with absorption of study treatment\n9. Patients who are unable or unwilling to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia\u002Fcachexia (palliative care)\n10. Patients who have any psychiatric, medical, or other condition that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give informed consent.\n11. Patients with contraindication to any of the required concomitant drugs or supportive treatments\n12. Patients unwilling or unable to comply with the protocol",{"count":138,"type":22},27,[25],"The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed\u002FRefractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.\n\nThe investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.\n\nTwenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.",[30,90],"2026-06-02",{"date":144,"type":45},"2026-06-04",{"date":146,"type":45},"2025-08-22",{"date":148,"type":22},"2027-12-31",{"name":150,"class":52},"Duke University",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":61},"100600383","phase-2-inobrodib-pomalidomide-and-dexamethasone-in-relapsed-or-refractory-multiple-myeloma-100600383","NCT07096778","Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma","A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","DoMMino-1","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy\n* Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate hematological, renal and hepatic function\n* Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners\n\nExclusion Criteria:\n\n* Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest; any antibody based therapy within 30 days\n* Prior treatment with p300\u002FCBP bromodomain inhibitors\n* Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)\n* Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment\n* Major surgery within 4 weeks of the first dose of study treatment\n* Live vaccine within 4 weeks of study treatment\n* Active or unresolved adverse events\n* Active malignancies (progressing or requiring change in treatment) in the last 24 months other than multiple myeloma\n* Female patients who are pregnant or breast-feeding at any time during the study\n* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data",{"count":160,"type":22},100,[25],"The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.",[29,30],[165,166,167,168,169,170],"Inobrodib","Pomalidomide","Pomalyst","Imnovid","Dexamethasone","p300-CBP Transcription Factors","2026-05-29",{"date":142,"type":45},{"date":174,"type":45},"2026-01-22",{"date":176,"type":22},"2029-12-01",{"name":178,"class":179},"CellCentric Ltd.","INDUSTRY",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100639037","phase-1-study-to-evaluate-the-safety-of-uf-kure-bcma-car-t-cells-in-advanced-myeloma-100639037","NCT07611149","Study to Evaluate the Safety of UF-KURE-BCMA CAR T-Cells in Advanced Myeloma","A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety of UF-KURE-BCMA Cells in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\nSubjects must meet ALL of the following criteria to be eligible for study enrollment:\n\n1. Age: ≥18 years at time of signing informed consent\n2. Diagnosis: Documented multiple myeloma meeting one of the following:\n\n   * Relapsed disease: Progression after achieving at least minimal response (MR) to prior therapy\n   * Refractory disease: Non-responsive or progressive disease while on therapy or within 60 days of last treatment (in subjects who achieved ≥MR on prior therapy)\n3. Prior Therapy:\n\n   * Received ≥3 prior lines of anti-myeloma therapy\n   * Prior therapy must include:\n\n   At least one proteasome inhibitor At least one immunomodulatory drug (e.g., lenalidomide, pomalidomide, thalidomide) At least one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab) o Prior anti-BCMA CAR-T therapy is permitted if subject achieved PFS ≥6 months post-infusion\n4. Measurable Disease: At least one of the following at screening (for response assessment eligibility):\n\n   * Serum M-protein ≥0.5 g\u002FdL by protein electrophoresis (SPEP)\n   * Urine M-protein ≥200 mg\u002F24 hours by protein electrophoresis (UPEP)\n   * Serum free light chain (FLC) difference ≥10 mg\u002FdL with abnormal FLC ratio Note: Subjects with non-measurable disease may enroll for safety assessment\n5. Performance Status: ECOG Performance Status 0-2 (see Appendix A)\n6. Organ Function: Adequate organ function as defined by:\n\n   Hepatic:\n\n   o Total bilirubin ≤2× institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome\n   * AST and ALT ≤2.5× institutional ULN\n\n   Renal:\n\n   o Calculated creatinine clearance ≥30 mL\u002Fmin (Cockcroft-Gault formula)\n\n   Cardiac:\n\n   o Left ventricular ejection fraction (LVEF) ≥45% by echocardiogram or MUGA\n\n   Pulmonary:\n\n   o ≤Grade 1 dyspnea\n\n   o Oxygen saturation ≥92% on room air\n\n   o If PFTs performed: FEV₁ ≥50% predicted and DLCO ≥40% predicted (corrected for hemoglobin)\n7. Prior Therapy Washout:\n\n   o ≥2 weeks since last radiation or systemic anti-myeloma therapy (standard agents)\n\n   o ≥4 weeks since last investigational therapy\n\n   o ≥6 weeks since autologous stem cell transplant\n8. Informed Consent: Ability to understand and willingness to provide written informed consent\n9. Contraception Requirements (for subjects of reproductive potential):\n\nFemale subjects:\n\no Women of childbearing potential must: Have negative serum pregnancy test at screening Agree to use highly effective contraception (failure rate \\\u003C1% per year) from enrollment through 6 months post-CAR-T infusion\n\n* Acceptable methods: bilateral tubal ligation, male partner sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing IUD, copper IUD\n* Sexual abstinence is acceptable if consistent with subject's preferred lifestyle\n\nMale subjects:\n\n* Must agree to use condom plus effective contraception if partner is of childbearing potential\n* Must refrain from sperm donation from enrollment through 6 months post-CAR-T infusion\n\nExclusion Criteria:\n\nSubjects meeting ANY of the following criteria will be excluded:\n\n1. Disease-Specific Exclusions:\n\n   * Active CNS involvement by multiple myeloma\n   * Plasma cell leukemia\n   * History of allogeneic hematopoietic stem cell transplantation\n2. Malignancy Exclusions:\n\n   o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer\n3. Cardiovascular Exclusions:\n\n   * New York Heart Association (NYHA) Class IV congestive heart failure\n   * Unstable angina pectoris\n   * Clinically significant cardiac arrhythmias\n   * Myocardial infarction, stroke, or TIA within 6 months of enrollment\n4. Infectious Disease Exclusions:\n\n   * Known HIV infection or AIDS-related illness\n   * Active hepatitis B or C infection:\n\nPositive HBsAg, or Positive anti-HBc or anti-HCV with detectable viral nucleic acid by PCR\n\n* Active infection requiring systemic therapy 5. Neurological Exclusions:\n* History of clinically relevant CNS pathology including:\n\nEpilepsy or seizure disorders Paresis, aphasia Uncontrolled cerebrovascular disease Severe brain injury Dementia Parkinson's disease 6. Autoimmune Disease:\n\n* Active autoimmune disease requiring systemic immunosuppression \\>15 mg\u002Fday prednisone equivalent within past 6 months\n* Examples: rheumatoid arthritis, lupus",{"count":188,"type":22},12,[63],"The goal of this study is to evaluate the safety of a new type of CAR T-cell, UF-KURE-BCMA, for the treatment of patients with advanced multiple myeloma that has not responded to other therapies. The main question is whether the use of these new CAR T-cells is safe for patients with this condition. Secondarily, the study will also look at the response of myeloma to this therapy.",[30,90],"2026-05-22",{"date":194,"type":45},"2026-05-28",{"date":196,"type":22},"2026-09-01",{"date":198,"type":22},"2028-12-30",{"name":200,"class":179},"Kure Cells, INC",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100504871","phase-1-combination-treatment-of-belantamab-mafodotin-and-venetoclax-in-treatment-of-relapsed-and-refractory-t1114-multiple-myeloma-100504871","NCT05853965","Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma","Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma (Phase I\u002FIIa) The BELI(E)VE-Trial","BELI(E)VE","Relapsed and refractory t(11;14) Multiple Myeloma (RRMM)\n\nInclusion criteria:\n\n1. Subjects must be ≥ 18 years of age.\n2. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n3. Subjects must voluntarily sign and date an in-formed consent form\n4. Subjects must have had documented multiple myeloma requiring treatment as defined by the criteria below:\n\n   Monoclonal plasma cells in the bone marrow \\> 10% and\u002For presence of a biopsy proven plasmacytoma at some point in their disease history requiring treatment according diag-nostic criteria (IMWG updated criteria 2014, Rajkumar et al. 2014) with measurable dis-ease at screening (serum M-protein \\> 500 mg\u002FdL or urine M protein 200 mg\u002F24h, in case of oligosecretory MM serum free light chain \\> 10mg\u002FdL and abnormal kap-pa\u002Flambda free light chain ratio)\n5. Cytogenetics\u002FFISH confirming t(11;14)\n6. Prior treatment requirements:\n\n   Prior treatment requirements:\n\n   a. Subjects must have received at least 1 prior treatment line (induction, high-dose, consolidation and maintenance is considered as one treatment line). All patients have to have received at least one proteasome inhibitor and at least one immunomodulatory agent and at least one anti-CD38 monoclonal antibody.\n\n   b. Subjects must have documented evidence of progressive disease on or after the last treatment line.\n\n   c. Subjects with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: i. ASCT was \\>100 days prior to initiating study treatment, and ii. No active bacterial, viral, or fungal in-fection(s) present.\n7. Subjects must have adequate organ function, defined as follows:\n\n   a. Hemoglobin ≥8.0 g\u002FdL (without transfusion of red blood cells for the past 14 days) b. Absolute neutrophil count ≥ 1.5 x109\u002FL (with-out growth factor support for the past 14 days) c. Platelet count more or equal 75 x109\u002FL (with-out growth factor or platelet stimulating agents for the past 14 days) d. Adequate hepatic function per local laborato-ry reference range as follows: i. Aspartate aminotransferase (AST) ≤ 2,5 x upper limit of normal (ULN); ii. Alanine aminotransferase (ALT) ≤ 2.5 x ULN iii. Total bilirubin ≤ 1.5 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bili-rubin ≤ 1.5 x ULN). Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%.\n\n   e. Subjects must have adequate renal function as demonstrated by eGFR ≥30 mL\u002Fmin\u002F 1.73 m2 as calculated by Modified Diet in Renal Disease (MDRD) formula f. Spot urine (albumin\u002Fcreatinine ratios (spot urine) \\\u003C500 mg\u002Fg (56 mg\u002Fmmol) OR Urine Dipstick Negative\u002Ftrace (if 1+ only eligible if confirmed \\\u003C500 mg\u002Fg (56 mg\u002Fmmol) by albumin\u002Fcreatinine ratio (spot urine from first void) g. Corrected serum calcium ≤ 14 mg\u002FdL (≤3,5 mmol\u002FL); or free ionized calcium ˂ 6,5 mg\u002FdL (˂1,6 mmol\u002FL)\n8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   1. Is not a woman of childbearing potential (WOCBP) OR\n   2. Is a WOCBP and using a contraceptive method that is highly effective\n9. Male participants are eligible to participate if they agree to the refrain from donating sperm and either bei abstinent from heterosexual intercourse or agree to use a highly effective contraceptive method during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm\n10. All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.\n11. All subjects must agree not to share study medication.\n12. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of en-rolment except for alopecia.\n\nExclusion Criteria:\n\n1. Subject has received prior Venetoclax and\u002For anti BCMA treatment.\n2. Participant has used an investigational drug or approved systemic anti-myeloma therapy with-in 14 days or five half-lives, whichever is short-er, preceding the first dose of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of Dexa-methasone 40 mg\u002Fday for a maximum of 4 days) up to 7 days before treatment.\n3. Participant has had plasmapheresis or radia-tion therapy within 7 days prior to first dose of study treatment\n4. Participant has current corneal epithelial dis-ease except mild changes in corneal epitheli-um\n5. Participant has current unstable liver or biliary disease\n6. Participant has a presence of active renal con-dition (infection, requirement for dialysis or any other condition that could affect participant's safety).\n7. Participant has had major surgery ≤ 4 weeks prior to initiating study treatment. Kyphoplasty is not considered a major surgery.\n8. Participant must not use contact lenses while participating in this study. Bandage contacts may be prescribed by an eye care professional if needed.\n9. Participant has any evidence of active mucosal or internal bleeding or other gastrointestinal disease that may significantly alter the absorp-tion of oral drugs.\n10. Participant has evidence of cardiovascular risk as defined in the protocol\n11. Participant has known immediate or delayed hypersensitivity reaction or idiosyncratic reac-tions to IMPs or drugs chemically related to IMPs, or any of the components of the study treatment\n12. Participant has an invasive malignancy other than disease under study within 5 years before trial inclusion, except\n\n    * Adequately treated in situ carcinoma of the cervix uteri or the breast;\n    * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n    * Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment;\n    * Previous malignancy with no current evi-dence of disease, and which was confined and surgically resected (or treated with other mo-dalities) with curative intent and unlikely to im-pact survival during the duration of the study.\n13. Participant is pregnant or lactating\n14. Participants who have had prior allogeneic stem cell transplant.\n15. Participants with symptomatic amyloidosis, ac-tive POEMS syndrome (polyneuropathy, or-ganomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, skin changes) or active plasma cell leukaemia at the time of screening.\n16. Participants with any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, ob-taining informed consent or compliance to the study procedures.\n17. Subject is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B sur-face antigen (HBsAg) or antibodies to hepatitis B surface and core antigen (anti HBs and anti HBc respectively), or hepatitis C (anti-HCV an-tibody positive or HCV RNA quantitation posi-tive).\n18. Current immune or inflammatory conditions re-quiring immunosuppressive treatment (e.g. systemic lupus erythematosus, rheumatoid ar-thritis).\n19. Subject must not have received any live vac-cines within 8 weeks prior to first dose of study treatment.\n20. Subject must not use or anticipate the use of prohibited medications or foods during study participation.\n21. Subject does not have a history of or show any signs of known meningeal\u002Fcentral nervous sys-tem involvement by myeloma.\n22. Evidence of other clinically significant uncon-trolled condition(s) that is likely to interfere with the study proce-dures or results, or that in the opinion of the investigator, would constitute a hazard for the participation in this study.\n23. Subject is known or suspected of not being able to comply with the study protocol. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit or confound the pro-tocol-specified assessments.\n24. Treatment with any of the following within 7 days prior to the first dose of study drug:\n\n    1. moderate or strong cytochrome P450 3A (CYP3A) inhibitors\n    2. moderate or strong CYP3A inducers\n25. Administration or consumption of any of the fol-lowing within 3 days prior to the first dose of study drug:\n\n    1. grapefruit or grapefruit products\n    2. Seville oranges (including marmalade con-taining Seville oranges)\n    3. star fruit\n26. Participation in any other clinical trial (with the exclusion of observational studies)",{"count":210,"type":22},45,[63,25],"The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed\u002Frefractory multiple myeloma bearing the translocation t(11;14)",[31,30],[215,216,217,218],"t(11;14)","venetoclax","belantamab mafodotin","multiple myeloma","2026-05-14",{"date":221,"type":45},"2026-05-18",{"date":223,"type":45},"2023-06-28",{"date":225,"type":22},"2028-12",{"name":227,"class":52},"Universitätsklinikum Hamburg-Eppendorf",5,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":77},"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":237,"type":22},18,[63],"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",[31,30,241],"Refractory Multiple Myeloma",[31,30,241],"2026-05-08",{"date":245,"type":45},"2026-05-12",{"date":247,"type":45},"2021-10-05",{"date":249,"type":22},"2028-02-24",{"name":251,"class":52},"Marcela V. Maus, M.D.,Ph.D.",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":278,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100598722","phase-1-a-study-to-evaluate-a-novel-gene-therapy-in-patients-with-relapsed-and-refractory-multiple-myeloma-100598722","NCT07075185","A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma","inMMyCAR","Inclusion Criteria:\n\n* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease\n* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody\n* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1\n* Participants must have acceptable laboratory values as defined by the protocol\n\nExclusion Criteria:\n\n* Participants must not have known central nervous system (CNS) involvement with myeloma\n* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis\n* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy\n* Participants cannot require systemic steroids for any condition",{"count":261,"type":22},70,[63],"The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.",[30,265,266,267,268,269,270,271,272,273,274,275,276,277],"Myeloma Multiple","Multiple Myeloma Progression","Neoplasms by Histologic Type","Neoplasm","Hemostatic Disorders","Vascular Disorder","Paraproteinemias","Blood Protein Disorders","Hematologic Disease and Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Disease","Gene Therapy",[279,218,280,281],"in vivo CAR-T","gene therapy","BMCA","2026-04-22",{"date":284,"type":45},"2026-04-24",{"date":286,"type":45},"2025-07-16",{"date":288,"type":22},"2042-05",{"name":290,"class":179},"Kelonia Therapeutics, Inc.",7,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":4},"100625378","phase-1-phase-iii-study-of-senl103-for-relapsed-or-refractory-multiple-myeloma-a-multicenter-open-label-single-arm-trial-100625378","NCT07421856","Phase I\u002FII Study of SENL103 for Relapsed or Refractory Multiple Myeloma: A Multicenter, Open-Label, Single-Arm Trial.","A Multicenter, Open-label, Single-Arm Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of SENL103 Autologous T Cell Injection (S103) in Subjects With Relapsed or Refractory Multiple Myeloma.","Inclusion Criteria:\n\n* 1.The subject must understand and voluntarily sign the informed consent form (ICF) before any study-related assessments\u002Fprocedures.; 2.Male or female subjects aged 18 to 70 years (inclusive) at the time of signing the informed consent form; 3.Life expectancy of no less than 12 weeks; 4.ECOG performance status of 0 to 1; 5.Diagnosis of relapsed\u002Frefractory multiple myeloma (RRMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, with at least 3 prior lines of therapy, including regimens based on proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies; disease progression documented by radiographic evidence within 12 months following the most recent anti-myeloma therapy.; 6.The subject must have measurable multiple myeloma disease, which must meet at least one of the following criteria:\n\n  1. Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;\n  2. Serum M-protein levels: IgG type M-protein ≥10 g\u002FL; or IgA, IgD, IgE, IgM type M-protein ≥5 g\u002FL;\n  3. 24-hour urine M-protein level ≥200 mg;\n  4. For light chain multiple myeloma without measurable serum or urine lesions: serum free light chain (sFLC) ≥100 mg\u002FL and abnormal serum κ\u002Fλ free light chain ratio;\n\nExclusion Criteria:\n\n* 1.Subjects with asymptomatic (smoldering) multiple myeloma; 2.Subjects with multiple myeloma with extramedullary lesions (excluding isolated extramedullary lesions with a maximum cross-sectional diameter ≤3 cm)； 3.Subjects with active plasma cell leukemia (defined as peripheral blood plasma cells \\>5%), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis at screening; 4.Subjects with clinically significant cardiovascular disease, including any of the following:\n\n  1. QTc interval \\>470 ms (QTc interval corrected using the Fridericia formula);\n  2. New York Heart Association (NYHA) Class II or higher heart failure;\n  3. Unstable angina or acute myocardial infarction within 6 months prior to signing the informed consent form (ICF);\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n  5. Poorly controlled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg); Arrhythmia that is either clinically significant or requires antiarrhythmic therapy (e.g., persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes, or complete left bundle branch block); 5.Subjects who have previously received BCMA-targeted therapies, BCMA CAR-T therapy, or other cellular therapies 6.Subjects who have previously received the following antineoplastic therapies: monoclonal antibody treatment for multiple myeloma within 21 days prior to autologous stem cell collection, cytotoxic chemotherapy or proteasome inhibitors within 14 days prior to autologous stem cell collection, immunomodulatory agents within 7 days prior to autologous stem cell collection, or any other antineoplastic therapies within 14 days or at least 5 half-lives (whichever is longer) prior to autologous stem cell collection; 7.Subjects with interstitial lung disease or interstitial pneumonia at the time of signing the ICF; 8.Subjects with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and psoriasis) or other conditions requiring immunosuppressive therapy (except for low-dose corticosteroids) at screening; 9.Subjects who have received live or inactivated vaccines within 28 days prior to signing the ICF;","70 Years",{"count":301,"type":22},24,[63,25],"To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma",[30,29],[306,31,307],"S103","CAR-T","2026-02-11",{"date":310,"type":45},"2026-02-19",{"date":312,"type":22},"2026-02-01",{"date":314,"type":22},"2030-02-01",{"name":316,"class":179},"Hebei Senlang Biotechnology Inc., Ltd.",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":299,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":77},"100579712","phase-2-subcutaneous-talquetamab-in-elderly-patients-with-multiple-myeloma-in-early-relapse-100579712","NCT06827860","Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse","A Phase 2 Single-Arm Study of Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse","Inclusion Criteria:\n\n* Documented multiple myeloma as defined by the criteria below:\n\n  * Multiple myeloma diagnosis according to the IMWG diagnostic criteria\n  * Measurable disease at screening as assessed by central laboratory, defined by at least 1 of the following:\n* Serum M-protein level ≥0.5 g\u002FdL (central laboratory)\n* Urine M-protein level ≥200 mg\u002F24 hours (central laboratory)\n* Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg\u002FdL or \\>100 mg\u002FL (central laboratory) provided the serum free light chain ratio is abnormal (0.22 to 1.52 \\[central laboratory\\])\n\nNOTE: Local laboratory results of blood and urine M-protein measurements may be used to determine initial eligibility. Central laboratory results should still be obtained prior to the start of administration of study treatment in order to establish baseline values and confirm the results from the local laboratory.\n\n• Relapsed or refractory disease as defined below:\n\n* Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria \\>60 days after cessation of treatment.\n* Refractory disease is defined as \\\u003C25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment. Received at least 1 prior line(s) of antimyeloma therapy including a minimum of 2 consecutive cycles\n\nNOTE: Participant must have undergone ≥1 complete cycle of treatment for each regimen, unless progressive disease was the best response to the regimen.\n\nNOTE: A single line of therapy may consist of 1 or more agents and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg\u002Fday for 4 days) would not be considered prior lines of therapy.\n\n* Subject must have received at least ≥2 prior line(s) of systemic antimyeloma therapy of treating physician's discretion, including a PI and an IMID\n* Subjects who are anti-CD38 monoclonal antibody-naïve, exposed, or refractory will be allowed in Part 1; Only subjects who are anti-CD38 antibody-naïve or exposed will be allowed in Part 2, whereas subjects refractory to anti-CD38 monoclonal antibody will not be allowed in Part 2\n* Have clinical laboratory values meeting the following criteria during the Screening Phase: Hematology Hemoglobin: ≥7 g\u002FdL (≥4.96 mmol\u002FL; without transfusion support or erythropoietin use within 7 days before the laboratory test) Platelets: ≥50×109\u002FL (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test) Absolute neutrophil count: ≥1.0×109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated GCSF before the laboratory test) Chemistry AST and ALT: ≤2.5×ULN eGFR: ≥30 mL\u002Fmin based on Modified Diet in Renal Disease Formula calculation Total bilirubin: ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required) Serum calcium corrected for albumin: ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL;)\n* Human immunodeficiency virus-positive participants are eligible if they meet all of the following:\n\n  * No detectable viral load (ie, \\\u003C50 copies\u002FmL) at screening\n  * CD4+ count \\>300 cells\u002Fmm3 at screening\n  * No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening\n  * Receiving HAART. Any changes in HAART due to resistance\u002Fprogression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening.\n\nNote: HAART that could interfere with study treatment is excluded (consult the sponsor for a review of medications prior to enrollment) • A male participant must agree to wear a condom (with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 100 days after receiving the last dose of study treatment.\n\nNOTE: If the male participant is vasectomized, he still must wear a condom (with foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository), but his female partner is not required to use contraception.\n\n* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment.\n* Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 2, including to not donate blood or blood components during the study and for 100 days after the last dose of study drug)\n* Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the subject's disease.\n\nExclusion Criteria:\n\nAny potential subject who meets any of the following criteria will be excluded from participating in the study:\n\n* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab and daratumumab Investigator's Brochure and appropriate prescribing information).\n* Prior treatment with T-cell-engaging antibodies\n* Prior antitumor therapy as follows, prior to the first dose of study drug:\n\n  o Any prior GPRC5D-directed therapy\n  * Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n  * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.\n  * Investigational vaccine other than SARS CoV-2 vaccine approved\u002F in use under emergency approval within 4 weeks o Live, attenuated vaccine within 4 weeks\n  * Monoclonal antibody treatment for multiple myeloma within 21 days.\n  * Cytotoxic therapy within 21 days.\n  * Proteasome inhibitor therapy within 14 days. o Immunomodulatory agent therapy within 14 days. o Radiotherapy within 14 days or focal radiation within 7 days\n* Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.\n* Received a maximum cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14-day period before the first dose of study drug.\n* Stem cell transplantation:\n\n  * Previous allogenic stem cell transplant\n  * Received an autologous stem cell transplant ≤12 weeks before the first dose of study drug\n* Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.\n* Plasma cell leukemia (\\>20% circulating plasma cells and\u002For \\>2.0 x 109\u002FL plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \\[M-protein\\], and skin changes), or primary amyloid light chain amyloidosis.\n* Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed\u002Frefractory multiple myeloma. The only allowed exceptions are:\n\n  o Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured\n\n  o Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured\n  * Noninvasive cervical cancer treated within the last 24 months that is considered completely cured\n  * Localized prostate cancer (N0M0):\n\n    \\- With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance\n    * With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence, or\n    * History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence\n  * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence\n  * Other malignancy that is considered cured with minimal risk of recurrence.\n* Stroke or seizure within 6 months prior to signing ICF.\n* Any of the following:\n\n  * Active Hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status see Section Hepatitis B Virus Testing 8.7.1.18.7.1 for further required assessments.\n  * Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the participant is eligible for the study.\n* Any concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n\n  * Uncontrolled diabetes o Acute diffuse infiltrative pulmonary disease\n  * Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy within 7 days of start of study treatment\n  * Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment.\n\nEXCEPTION: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed.\n\n* Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status\n* Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n* History of non-compliance with recommended medical treatments • Plans to father a child while enrolled in this study or within 100 days after the last dose of study drug.\n\n  • Presence of the following cardiac conditions:\n* New York Heart Association stage III or IV congestive heart failure\n* Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization\n* Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration o History of severe non-ischemic cardiomyopathy • Major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.\n* NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate sponsor representative and resolve any issues before enrolling a participant in the study • Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal of DLCO \\\u003C50%).\n\nNote: FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 \\\u003C50% of predicted normal.\n\n• Known moderate of persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification.\n\nNote: Participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study.\n\nNOTE: Investigators should ensure that all study inclusion\u002Fexclusion criteria have been met at screening and prior to the first dose of study drug. If a subject's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, supportive treatment may be administered according to local standards of care, if necessary, so that eligibility criteria may be met and laboratory test(s) may be repeated once, to determine if the subject qualifies for the study. If inclusion\u002Fexclusion criteria are not met after further evaluation, the subject should be excluded from participation in the study.",{"count":325,"type":22},23,[25],"Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier. For patients who are refractory to at least 3 of the commonly administered PIs and IMiDs, occurring after 2 lines of therapy in many, the median overall survival is only 5 months. Elderly, frail patients are not often candidates at this point for aggressive therapies like stem cell transplantation and CAR T-cell therapy thus necessitating effective yet tolerable treatments for elderly patients in early relapse (1-3 prior therapy). Talquetamab is a GPRC5DxCD3 bispecific antibody that redirects patients' T cells to myeloma cells which express GPRC5D. In the phase 1 MonumenTAL-1, heavily pretreated patients with a median of 6 prior lines of therapy attained a 70% response rate with 405 μg\u002Fkg of subcutaneous (SC) talquetamab. Importantly, subcutaneous talquetamab was found to be tolerable for the treated population, which included 28% of patients aged ≥70, with only three patients experiencing dose-limiting toxicities in the form of grade 3 rashes which responded to steroids. The anti-CD38 antibody daratumumab eliminates CD38-positive T and B regulatory cells, potentiates the activity of bispecific antibodies like talquetamab, and may improve its efficacy when used in combination. The aim of this study will be to assess the efficacy and safety of treating elderly patients with relapsed\u002Frefractory multiple myeloma with at least ≥2 prior lines of therapy with subcutaneous talquetamab. Patients who have progressive disease on talquetamab or who fail to respond after 3 cycles will have subcutaneous daratumumab added to their regimen.",[30],[330,331,332,31],"Talquetemab","Elderly patients","Early relapse","2025-12-17",{"date":335,"type":45},"2025-12-18",{"date":337,"type":45},"2025-11-18",{"date":339,"type":22},"2028-01",{"name":341,"class":52},"Larysa Sanchez",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":77},"100612022","universal-car-t-cell-therapy-for-mm-100612022","NCT07248176","Universal CAR-T Cell Therapy for MM","A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r\u002Fr Multiple Myeloma","Inclusion Criteria:\n\n1. Expected survival of at least 3 months;\n2. Subjects should have measurable disease that meets the IMWG 2016 criteria;\n3. Previously received at least two lines of prior anti-myeloma therapy ；\n4. Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；\n5. BCMA positive；\n6. ECOG score 0-1；\n7. No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. History of other malignant tumors;\n3. Active autoimmune diseases requiring immunotherapy;\n4. Previously received allogeneic stem cell transplantation;\n5. Previous use of CAR-T cells or other genetically modified T cell therapies;\n6. Previously received targeted BCMA therapy;\n7. Severe cardiovascular disease;\n8. Active infection;\n9. Positive virology test;\n10. Clinically significant central nervous system (CNS) diseases or pathological changes.",{"count":350,"type":22},6,[352],"NA","This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r\u002Fr multiple myeloma.",[31,30,90],"2025-11-28",{"date":357,"type":45},"2025-12-01",{"date":359,"type":45},"2025-04-10",{"date":361,"type":22},"2028-04-18",{"name":363,"class":179},"Bioray Laboratories",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":372,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":382,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":77},"100553360","early-palliative-care-for-patients-with-multiple-myeloma-and-aggressive-lymphoma-100553360","NCT06485076","Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma","Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma","EPC-MM+L","Patient eligibility criteria:\n\nInclusion criteria:\n\n(i) Age ≥18 years; (ii) A new diagnosis of multiple myeloma or at progression of disease necessitating a change in treatment plan, or relapsed\u002Frefractory aggressive B cell lymphoma after one prior line of therapy; (iii) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; (iv) Willingness to complete symptom screening; and (v) At least one ESAS-r-plus symptom scored at ≥3 at time of recruitment.\n\nExclusion criteria:\n\n(i) Insufficient English literacy to complete study procedures; (ii) Hematologist-determined poor cognitive status; (iii) Current palliative care team involvement at PM or elsewhere; and (iv) Not receiving ongoing follow up with malignant hematology team at PM.\n\nCaregiver eligibility criteria:\n\nInclusion criteria:\n\n(i) Age ≥18 years; (ii) Caregiver of a patient with relapsed B cell lymphoma; and (iii) Willing to attend at least 1 PCC visit with the patient.\n\nExclusion criteria:\n\n(i) Insufficient verbal and\u002For written English literacy to complete study procedures; or (ii) Patient not participating in study.\n\nHealthcare provider eligibility criteria:\n\nInclusion criteria:\n\n(i) Specialized staff physician, fellow, clinical nurse specialist, or clinic nurse from the outpatient malignant hematology team or palliative care team at PM working clinically with patients with multiple myeloma; and (ii) Working in their clinical area for at least 12 months.",true,{"count":374,"type":22},144,[352],"Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date.\n\nThe goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) attending the Princess Margaret Cancer Centre. The main goals of the study are:\n\n* To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only)\n* To see if this early palliative care intervention works well for these patients and caregivers\n* To compare patient and caregiver experiences with early palliative care and usual care\n* To explore perceptions and experiences of providing palliative care among healthcare providers involved in the care of these patients and caregivers.\n\nPatients, and their respective caregivers if participating, will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their quality of life, symptom burden, mood, and satisfaction with care throughout the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care and their caregivers.\n\nSome patients and caregivers will be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Some healthcare providers who care for these patients will also be asked to take part in interviews at the end of the trial to describe their perceptions and experiences of providing palliative care.\n\nThe researchers will use the results of this study to guide in the development of a larger clinical trial.",[30,90,378,266,31,379,380,381],"Multiple Myeloma Stage III","B Cell Lymphoma","Lymphoma, B-Cell","Aggressive Lymphoma",[383,218,384,385,386],"early palliative care","quality of life","symptom management","aggressive lymphoma","2025-11-25",{"date":389,"type":45},"2025-12-03",{"date":391,"type":45},"2024-07-18",{"date":393,"type":22},"2027-06",{"name":76,"class":52},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100374967","phase-1-bcma-cd19-ccar-in-multiple-myeloma-and-plasmacytoid-lymphoma-100374967","NCT04162353","BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma","BCMA-CD19 cCAR in Relapsed and \u002For Refractory Multiple Myeloma and Plasmacytoid Lymphoma","Inclusion Criteria:\n\n* Signed written informed consent; Patients volunteer to participate in the research\n* Diagnosis is mainly based on the World Health Organization (WHO) 2008\n* Patients have exhausted standard therapeutic options\n* Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks\n* Female must be not pregnant during the study\n\nExclusion Criteria:\n\n* Patients declining to consent for treatment\n* Prior solid organ transplantation\n* Potentially curative therapy including chemotherapy or hematopoietic cell transplant\n* Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents",{"count":188,"type":22},[63],"This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and\u002For refractory multiple myeloma and plasmacytoid lymphoma.",[30,241,406],"Plasmacytoid; Lymphoma",[408,409,410,218,411],"BCMA","CD19","BCMA-CD19 cCAR T cells","plasmacytoid lymphoma","2025-09-10",{"date":414,"type":45},"2025-09-16",{"date":416,"type":45},"2019-07-01",{"date":418,"type":22},"2026-07",{"name":420,"class":179},"iCell Gene Therapeutics",2,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":77},"100503564","phase-1-a-phase-i-trial-to-establish-the-safety-and-maximum-tolerated-dose-of-high-affinity-autologous-bcma-targeting-chimeric-antigen-receptor-car-t-cells-in-patients-with-relapsed-and-refractory-b-cell-malignancies-100503564","NCT05836896","A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies","A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting CAR T-cells in Patients With Relapsed and Refractory B-cell Malignancies","CARLOTTA01","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Written informed consent of the subject\n* Able and willing to adhere to the trial protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Either Multiple Myeloma (MM):\n\n  1. relapsed or refractory disease after at least 2 lines of treatment including an Immunomodulatory drug, a proteasome inhibitor and an anti-cluster of differentiation 38 antibody or anti-cluster of differentiation 319 (SLAMF7; Elotuzumab) antibody AND\n  2. not eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit according to the investigator's discretion, prior treatment with other BCMA-targeting immunotherapies (including T-cell engaging antibodies, CAR T-cells and antibody-drug immuno-conjugates) is allowed AND\n  3. measurable disease defined by serum M-Protein ≥ 10 g\u002Fl OR urine M-Protein ≥ 200 mg\u002F24h OR serum free light chain \\> 100 mg\u002Fl of involved free light chain and abnormal serum free light chain ratio\n\n     OR\n\n     Diffuse large B-cell lymphoma (DLBCL):\n  4. Relapsed after or refractory to standard curative therapy (such as R-CHOP) and refractory to at least one course of standard salvage chemotherapy OR\n  5. Relapsed within one year after high-dose chemotherapy and autologous stem cell support OR\n  6. Relapsed after allogeneic stem-cell transplantation or approved anti-cluster of differentiation 19 CAR T-cell therapies.\n\n     AND (applicable to all DLBCL patients)\n  7. Not be eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit. This includes but is not limited to anti-cluster of differentiation 19 directed CAR T-cell therapies with approved constructs AND (applicable to all DLBCL patients)\n  8. Measurable disease according to Lugano criteria\n* Adequate organ function defined as:\n\n  1. Neutrophils ≥ 0.5 Gpt\u002Fl and Platelets ≥ 50 Gpt\u002Fl (unless due to subtotal infiltration of the bone marrow by underlying malignancy)\n  2. Lymphocytes ≥ 0.1 Gpt\u002Fl\n  3. Alaninaminotransferase and Asparataminotransferase ≤ 3.0x Upper limit of normal\n  4. Bilirubin ≤ 1.5x Upper limit of normal\n  5. Creatinine ≤ 1.5x Upper limit of normal\n  6. Adequate cardiac function i.e. left ventricular ejection fraction ≥ 50%, no major valve abnormalities or dyskinesias\n* A female of childbearing potential\\* may be enrolled providing she has a negative pregnancy test at screening and is routinely using a highly effective method of birth control (pearl index of ≤ 1 required) resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization). Male patients must also prac-tice a highly effective method of birth control and should not father a child at least until 12 months after infusion of CAR T-cells\n\nExclusion Criteria:\n\n* Any Central nervous system (CNS)-involvement by underlying disease\n* History of seizure or cerebrovascular ischemia \u002F hemorrhage within the last 12 months\n* History of any autoimmune Central nervous system disease (e.g. multiple sclerosis, amyotrophic lateral sclerosis, optic neuritis)\n* Ongoing neurologic conditions that in the opinion of the investigator might increase the risk for neurotoxicity or impair the assessment of CAR-associated neurotoxicity\n* Inadequate pulmonary function (i.e. need for continuous oxygen support)\n* Patients on hemodialysis\n* Any contraindications to Fludarabine and\u002For Cyclophosphamide as given in the Summary of product characteristics\n* Any other active malignancy requiring active treatment or interfering with the assessment of primary or secondary trial endpoints, adjuvant hormonal therapy is allowed\n* Positivity for anti-human immunodeficiency virus (HIV) immunoglobulin\n* Active or chronic infectious hepatitis B (HBV) and C (HCV) virus unless serology demonstrates clearance of infection (i.e. Polymerase chain reaction undetectable viral load for hepatitis)\n* Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or history of SARS-CoV2 infection within the past 3 months or active long coronavirus disease (COVID) syndrome\n* Uncontrolled bacterial, viral or fungal infections defined as infections needing in-patient and\u002For i.v. antimicrobial treatment\\*\n* Active Graft versus Host Disease defined as active symptoms of graft-versus-host disease or ongoing immunosuppressive treatment or prophylaxis within the last 30 days prior to application of MDC-CAR-BCMA001\n* Psychologic disorders, drug abuse or any other condition which might significantly impair a patient's ability to comply with the trial protocol\n* Patients who are expected to deteriorate during the time needed for manufacturing MDC-CAR-BCMA001 in spite of bridging therapy in the opinion of the investigator including\n* Any condition requiring systemic treatment with immunosuppressive drugs (including but not limited to steroids exceeding 20 mg Prednisolone per day)\n* Any antineoplastic treatment within 7 days prior to leukapheresis or within 2 weeks or 5 half-lives (whatever is shorter) of the start of lymphodepleting chemotherapy (palliative radiotherapy to lesions not essential for response assessment is allowed without a minimal washout period)\n* Any investigational therapy within 4 weeks or 5 half-lives (whatever is shorter) prior to apheresis or the start of lymphodepleting chemotherapy\n* History of allergic reactions to any drug or its ingredients \u002F impurities foreseen to be given as part of this trial according to the protocol\\*\n* Receipt of live vaccines within 2 weeks prior to leukapheresis and start of lymphodepleting chemotherapy\n* Pregnant or breastfeeding women. Breastfeeding has to be discontinued before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.\n* Women of childbearing potential, except women who meet the following criteria:\n\n  1. post-menopausal (12 months natural amenorrhoea or 6 months amenorrhoea with serum Follicle stimulating hormone \\> 40 U\u002Fml)\n  2. postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)\n  3. regular and correct use of a contraceptive method with an Pearl Index \\\u003C 1% per year\n  4. sexual abstinence\n  5. Vasectomy of the partner\n* Hypersensitivity known from medical history to one of the drugs used or their ingredients or to drugs with a similar chemical structure\n* Simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion)\n* Addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences\n* Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance).",{"count":431,"type":22},16,[63],"The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies",[435,436,437,90,30],"Neoplasms","Relapsed Diffuse Large B-cell Lymphoma (DLBCL)","Refractory Diffuse Large B-cell Lymphoma (DLBCL)",{"date":439,"type":45},"2025-08-24",{"date":441,"type":45},"2024-02-15",{"date":393,"type":22},{"name":444,"class":52},"Technische Universität Dresden",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":452,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":77},"100595413","phase-1-sequential-car-t-cells-targeting-bcmagprc5d-in-patients-with-relapsed-refractory-multiple-myeloma-100595413","NCT07032129","Sequential CAR-T Cells Targeting BCMA\u002FGPRC5D in Patients With Relapsed\u002F Refractory Multiple Myeloma","BAH2573","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Subjects with recurrent\u002Frefractory Multiple Myeloma who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and has signed the informed consent.\n\nExclusion Criteria:\n\n* Malignant tumors other than R\u002FR AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.","21 Years","90 Years",{"count":455,"type":22},60,[63,25],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed\u002F Refractory Multiple myeloma",[31,30,266,90],[460,461,462,307,463],"Multiple myeloma","myeloma","Autoimmune Diseases","GPRC5D","2025-06-13",{"date":466,"type":45},"2025-06-22",{"date":468,"type":45},"2025-04-29",{"date":470,"type":22},"2028-12-28",{"name":472,"class":52},"Essen Biotech",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":4},"100583766","phase-2-teclistamab-plus-autologous-lymphocyte-infusion-ali-for-the-treatment-of-rr-multiple-myeloma-100583766","NCT06880601","Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R\u002FR Multiple Myeloma","Teclistamab Plus Autologous Lymphocytes Infusion for the Treatment of Relapse\u002FRefractory Multiple Myeloma (TALIM)","TALIM","Inclusion Criteria:\n\n* • Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)\n\n  * Patient age is ≥ 18 years of age\n  * Patient has a Relapsed or refractory disease as defined below:\n\n    * Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria \\>60 days after cessation of treatment\n    * Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.\n  * Previous treatment with 1 or 2 lines of treatment (induction plus autologous stem cell transplant plus consolidation and maintenance has to be considered one single line)\n  * Previous triple exposure that included an IMID, a PI, and an anti-CD38 antibody (patients with no response or relapse after front line therapy with Dara-VTD or Dara-VRD are eligible)\n  * Progressive active symptomatic disease\n  * Patient has measurable disease as defined by any of the following:\n\n    * Serum M-protein level ≥0.5 g\u002FdL; or\n    * Urine M-protein level ≥200 mg\u002F24 hours; or\n    * Serum immunoglobulin free light chain ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n  * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n  * Able to adhere to the study visit schedule and all the other protocol procedures and requirements;\n  * Patient has the following laboratory parameters:\n\n    * Total lymphocytes count ≥ 0.3 x 109\u002FL\n    * Platelet count \\> 50 x 109\u002FL unless due to bone marrow involvement by MM\n    * Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MM\n    * Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MM\n    * Creatinine clearance ≥ 30 ml\u002Fmin\n  * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 2-7 days prior to C1D1\n  * Life expectancy ≥ 2 months\n  * Successful collection of at least 100 x 106\u002Fkg autologous lymphocytes before starting treatment with Te.\n  * Patient understands and voluntarily signs an informed consent form\n\nExclusion Criteria:\n\n* • Previous treatment with \\> 2 lines of therapy\n\n  * Patient has active central nervous system involvement with MM\n  * Received any prior BCMA-directed therapy\n  * Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:\n\n    * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less\n    * Investigational vaccine within 4 weeks\n    * Monoclonal antibody therapy within 21 days\n    * Cytotoxic therapy within 21 days\n    * PI therapy within 14 days\n    * IMiD agent therapy within 14 days\n    * Radiotherapy within 14 days or focal radiation within 7 days\n  * Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n  * Stem cell transplant:\n\n    * previous allogeneic stem cell transplant\n    * autologous stem cell transplant performed within 12 weeks\n  * Patients with plasma cell leukemia (presence of 5% or more plasma cells in conventional peripheral blood smear white blood cell differential count)\n  * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients\n  * Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM)\n  * Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy\n  * Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n    * Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS)\n    * Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n    * Non-invasive cervical cancer\n    * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted)\n    * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment)\n    * Other malignancy that is considered cured with minimal risk of recurrence in consultation with the treating physician\n  * Clinically relevant and active liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances\n  * Patient has any other concurrent severe and\u002For uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active\u002Fsymptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), active hemorrhage, psychiatric illness, active or uncontrolled infection that in the investigator opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form\n  * Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study.\n  * Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment\n  * Patient has a known history of HIV seropositivity\n  * Seropositive for hepatitis B: defined by a positive test for HbsAg. Participants with resolved infection (ie, participants who are HbsAg negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Participants with a known history of HBV infection must be screened using RT-PCR measurement of HBV DNA levels irrespective of serological results. Those who are RT-PCR positive will be excluded. Participants 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 RT-PCR (see Appendix 12).\n  * Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.",{"count":86,"type":22},[25],"The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI?\n\nParticipants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6",[485,30,29],"Multiple Myleoma",[31,487,488,489,490],"Relapse","Refractoriness","Teclistamab","Autologous lymphocyte infusion","2025-03-31",{"date":493,"type":45},"2025-04-03",{"date":495,"type":22},"2025-11-01",{"date":497,"type":22},"2029-11-01",{"name":499,"class":52},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":77},"100422092","phase-1-a-clinical-research-of-bcma-targeted-prime-car-t-cell-therapy-in-relapsedrefractory-multiple-myeloma-and-plasma-cell-disease-100422092","NCT04776330","a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Diagnose as relapsed \u002Frefractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression\n4. All genders, ages: 18 to 75 years#\n5. The expect time of survive is above 3 months;\n6. KPS\\>60\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;\n\n13\\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.","75 Years",{"count":509,"type":22},80,[63,25],"This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed\u002Frefractory Multiple Myeloma.",[31,513,30],"Neoplasm, Plasma Cell",[31,408,515],"prime Chimeric Antigen Receptor T Cell","2025-02-23",{"date":518,"type":45},"2025-02-25",{"date":520,"type":45},"2021-03-07",{"date":522,"type":22},"2027-07-01",{"name":524,"class":179},"Chongqing Precision Biotech Co., Ltd",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":507,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":77},"100383360","phase-1-bcma-targeted-car-t-cell-therapy-for-relapsedrefractory-multiple-myeloma-and-plasma-cell-disease-100383360","NCT04271644","BCMA-Targeted CAR-T Cell Therapy for Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Diagnose as relapsed \u002Frefractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression；\n4. All genders, ages: 18 to 75 years；\n5. The expect time of survive is above 3 months;\n6. KPS\\>60；\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n12. With single or venous blood collection standards, and no other cell collection contraindications;\n13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD；\n5. The patients treatment by inhibitor of T cell；\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.",{"count":509,"type":22},[63,25],"This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed\u002Frefractory Multiple Myeloma.",[31,513,30],[31,408,536],"Chimeric Antigen Receptor T Cell",{"date":518,"type":45},{"date":539,"type":45},"2019-04-01",{"date":522,"type":22},{"name":524,"class":179},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":551,"phases":4,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":77},"100581176","cost-utility-analysis-of-ambulatory-dose-escalation-of-bispecific-antibodies-in-multiple-myeloma-100581176","NCT06846905","Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma.","AmbuSpé","Inclusion Criteria:\n\n* Relapsed and\u002For refractory multiple myeloma\n* Treated with teclistamab, elranatamab ou talquetamab\n* More than 18 years old\n* Having received the information from the study and not having objected to participate\n* Day hospital care in case of clinical feasibility (good general condition, no rapid progression or major tumor burden, no current infection) and logistics (accommodated less than 30 minutes from the IUCT Oncopole for 48 hours after each dose escalation) or in conventional hospitalization at the IUCT Oncopole\n\nExclusion Criteria:\n\n* Illiterate subjects or those with a language barrier",{"count":550,"type":22},40,"OBSERVATIONAL","Multiple myeloma is the second most common haematological cancer. Recent innovations have made it possible for relapsed\u002Frefractory patients to benefit from the innovative immunotherapy of bispecific antibodies. These antibodies stimulate the immune system to attack tumour cells. The treatment involves an escalating dose of three subcutaneous injections every 2 to 4 days for a total of about 10 days, followed by a weekly treatment phase.\n\nThe University Hospital of Toulouse was the first centre in France to offer outpatient dose escalation for this innovative treatment. This form of treatment depends on clinical and logistical feasibility. Where appropriate, patients are treated in a conventional unit. An analysis carried out at Toulouse University Hospital suggests a response to treatment, with no increased risk of complications in the outpatient setting. Patients' quality of life may also be unaffected. In addition, given the increasing demand for care in a context of finite resources, the economic evaluation of healthcare initiatives is becoming essential if we are to maintain a high-quality healthcare system that is accessible to all.",[30],[460,435,555,556,557,558],"Plasma Cell","Antineoplastic Agents","Antibodies Bispecific","Outpatient Care","2025-02-20",{"date":561,"type":45},"2025-02-26",{"date":563,"type":45},"2025-01-20",{"date":565,"type":22},"2026-12-31",{"name":567,"class":52},"University Hospital, Toulouse",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":77},"100528257","phase-2-all-trans-retinoic-acid-in-combination-with-a-kpd-regimen-for-the-treatment-of-refractoryrelapsed-multiple-myeloma-100528257","NCT06158412","All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory\u002FRelapsed Multiple Myeloma","A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory\u002FRelapsed Multiple Myeloma (MM)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g\u002FL; or urinary M protein level ≥ 200 mg\u002F24 hours; or serum immunoglobulin free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum immunoglobulin kap\u002Flam light chain ratio.\n3. Diagnosis of refractory\u002Frelapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a \\\u003C25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.\n4. ECOG assessment of 0, 1, or 2.\n5. Life expectancy of at least 3 months.\n6. The patient\u002Flegal guardian must be able to read, understand, and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Patient who currently participating or planning to participate in any interventional clinical study.\n2. The investigator considers the patient unsuitable for participation in this study.\n3. Non-secretory myeloma.\n4. Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg\u002Fday dexamethasone equivalent dose within 2 weeks prior to initiation of treatment.\n5. Subjects who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment.\n6. Inadequate bone marrow reserve as defined by a platelet count \\\u003C30 x 109\u002FL or absolute neutrophil count \\\u003C1.0 x 109\u002FL.\n7. Subject has clinically significant lung disease, including: (1) Subject has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal. Please note that patients suspected of having COPD will be required to undergo FEV1 testing and subjects must be excluded if FEV1 is \\\u003C50% of predicted normal. (2) Subjects who have had moderate or severe persistent asthma within the past 2 years or currently have any category of uncontrolled asthma. (Please note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma may participate in this study)\n8. Subjects with clinically significant cardiac disease, including (1) Myocardial infarction within 6 months prior to Day 1 of Cycle 1, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure, New York Heart Association Class III-IV). (2) Cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\], 4th Edition, Grade 4 edition grade 2 or higher) or clinically significant ECG abnormalities. (3) Screening 12-lead ECG showing a baseline QT interval (QTcF) corrected by the Friedreichian formula \\>470 ms.\n9. Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma.\n10. Creatinine clearance \\\u003C20 mL\u002Fmin.\n11. Known allergy to components of the test product, or severe allergy or hypersensitivity to humanized products.\n12. The subject has a concurrent serious and\u002For uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, infections, hypertension, etc.) that may interfere with the study procedures or results or that, in the opinion of the investigator, may pose a risk to participation in this study.\n13. Subjects known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or C.\n14. History of active malignancy within the past 5 years, except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or cured within 5 years with minimal risk of recurrence in the opinion of the local investigator, in agreement with the principal investigator.\n15. Subjects known or suspected of not being able to comply with the study protocol (e.g. due to alcoholism, drug dependence, or psychological disorders), or the subject has any condition that, in the investigator's belief that participation would not be in the subject's best interest (e.g., detrimental to their well-being) or would likely prevent, limit, or confound protocol-specified assessments.\n16. Pregnant or lactating females.\n17. Peripheral neuritis ≥ grade 3.",{"count":7,"type":22},[25],"To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.",[30,90],"2025-02-18",{"date":581,"type":45},"2025-02-19",{"date":583,"type":45},"2023-11-22",{"date":585,"type":22},"2025-12-31",{"name":587,"class":52},"The First Affiliated Hospital of Xiamen University",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":77},"100533399","phase-1-a-trial-of-selinexor-ruxolitinib-and-methylprednisolone-100533399","NCT06225310","A Trial of Selinexor, Ruxolitinib and Methylprednisolone","A Phase I Trial of Selinexor, Ruxolitinib and Methylprednisolone for Patients With Relapsed\u002FRefractory Multiple Myeloma","KPT-IST-391","Inclusion Criteria:\n\nPatients must meet all the following inclusion criteria to be eligible to enroll in this study:\n\n1\\. Has a diagnosis of MM based on standard criteria as follows:\n\nMyeloma criteria: Must be At least 1 of 2 1. Clonal bone marrow plasma cells \\>10% 2. Biopsy-proven bony or extramedullary plasmacytoma\n\nActive Myeloma criteria: Active Myeloma criteria: Must Meet At Least ONE of the Following:\n\nMeet at least one of the sub-criteria for #1 Evidence of End Organ Damage (a, b, c, or d), OR Meet sub-criteria #2. 60% or greater bone marrow plasma cells, OR Meet sub-criteria #3 Serum free light chain ratio, OR Meet sub-criteria #4 More than one focal lesion on MRI \\> 5mm in size.\n\n1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically\n\n   1. Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1mg\u002FdL) higher than the upper limit of normal or \\>2.75 mmol\u002FL (\\>11mg\u002FdL)\n   2. Renal insufficiency: creatinine clearance \\\u003C40 mL per minute or serum creatinine \\>177mol\u002FL (\\>2mg\u002FdL)\n   3. Anemia: hemoglobin value of \\>20g\u002FL below the lowest limit of normal, or a hemoglobin value \\\u003C100g\u002FL\n   4. Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET\u002FCT. If bone marrow has \\\u003C10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement\n2. 60% or greater clonal plasma cells on bone marrow examination\n3. Serum involved \u002F uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg\u002FL (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)\n4. More than one focal lesion on MRI that is at least 5mm or greater in size\n\nThe patient must have met the criteria for Active Myeloma at some stage following the diagnosis of Myeloma. Source documentation for both Myeloma and Active Myeloma will be required.\n\n2\\. Patients with relapsed\u002Frefractory multiple myeloma with at least three prior lines of therapy 3. Received an\n\n1. Anti-CD38 antibody\n2. Immunomodulatory agent (IMiD)\n3. Proteasome inhibitor (PI) 4. Currently has MM with measurable disease, defined as:\n\n   * a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g\u002FdL and\u002For urine monoclonal protein levels of at least 200 mg\u002F24 hours\n   * for patients without measurable serum and urine M-protein levels, an involved SFLC \\> 100 mg\u002FL or abnormal SFLC ratio\n   * for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 5500 mg\u002FL or meet other measurable disease eligibility criteria\n   * for patients with IgA MM, total IgA of \\> 700 mg\u002FdL 5. Currently has progressive MM: MM patients that are relapsed or have refractory disease from at least 3 regimens or lines of therapy are eligible for enrollment provided they fulfill the other eligibility criteria:\n   * patients are considered relapsed, when they progress greater than 60 days from their last dose of treatment\n   * patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose 6. Adequate hepatic function within 14 days prior to C1D1: Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \\\u003C 3 × ULN), and Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to \\\u003C 2 × ULN.\n\n     7\\. Adequate renal function within 14 days prior to C1D1 as determined by OR estimated CrCl of \\> 60 mL\u002Fmin, calculated using the Cockcroft and Gault formula (140 - Age) • Mass (kg)\u002F (72 • creatinine mg\u002FdL); multiply by 0.85 if female (87)(Appendix 5).\n\n     8\\. Adequate hematopoietic function within 14 days prior to C1D1: total WBC count ≥1500\u002Fmm3, ANC ≥1000\u002Fmm3, hemoglobin ≥8.5 g\u002FdL and platelet count ≥75,000\u002Fmm3 (patients for whom \\\u003C50% of BM nucleated cells are plasma cells) or ≥50,000\u002Fmm3 (patients for whom ≥50% of BM nucleated cells are plasma cells).\n\n     9\\. Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, G-CSF, GM-CSF, and platelet stimulators (e.g., eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.\n\n     10\\. Patients must have:\n   * At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the start of study treatment\n   * At least a 1-week interval from the last platelet transfusion prior to the start of study treatment\n   * However, patients may receive RBC and\u002For platelet transfusions as clinically indicated per institutional guidelines during the study 11. Female patients of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active must use highly effective methods of contraception throughout the study and for one month following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period. Specifically:\n   * 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 and again within 24 hours of starting treatment and must either commit to continued abstinence from heterosexual intercourse or use acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, and at least 28 days before she starts therapy. 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 vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.\n\n     † A FCBP (female of childbearing potential) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) 12. Able to take antiplatelet therapy if platelet count is above 30 x 109\u002FL. Options include aspirin (acetylsalicylic acid, ASA) at 81 or 325\u002Fmg\u002Fdaily, warfarin low molecular weight hepairin, Pradaza, Eliquis, or Xarelto.\n\n     13\\. Patients with history of human immunodeficiency virus (HIV) are eligible if they have CD4+ T cell counts ≥350 cells\u002FµL, negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.\n\n     14\\. Patients with untreated hepatitis C virus (HCV) are eligible if there is a documentation of negative viral load per institutional standard.\n\n     15\\. Age ≥ 18 years of age. 16. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.\n\n     17\\. Able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\nPatients meeting any of the following exclusion criteria are not eligible to enroll in this study:\n\n1. Patients who had prior exposure to ruxolitinib or selinexor\n2. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 3 years prior to randomization. Cancer treated with curative intent for \\>5 years previously and without evidence of recurrence will be allowed.\n3. Have light chain amyloidosis\n4. Have plasma cell leukemia\n5. Have history of active tuberculosis\n6. Have any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, POEMS syndrome \\[polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes\\], primary amyloidosis, etc.) that is likely to interfere with study procedures.\n7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.\n8. Received the following prior therapy:\n\n   * Chemotherapy within 3 weeks of study drugs\n   * Corticosteroids (\\>20 mg\u002Fdaily prednisone or equivalent) within 3 weeks of study drugs to ensure that steroid dose intensity at the beginning of the treatment is not altered by administration of steroids prior to the study. Consumption of steroids within 3 weeks of the treatment may interfere with efficacy and side effects due to differences of steroid intensity.\n   * Immunotherapy, immunomodulatory drugs, or proteasome inhibitors within 3 weeks before administration of study drugs\n   * Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.\n   * Use of any other experimental drug or therapy within 28 days of study drugs\n   * Strong CYP3A4 inhibitors, strong CYP3A4 inducers and fluconazole doses \\>200 mg daily within 5 half-lives before study drugs. (For example, clarithromycin has half-life of 4 hours so washout period for clarithromycin is 20 hours.)\n9. Known intolerance, hypersensitivity, or contraindication to glucocorticoids.\n10. Known hypersensitivity to compounds of similar chemical or biological composition to ruxolitinib or steroids.\n11. Concurrent use of other anti-cancer agents or treatments.\n12. Severe hypercalcemia, i.e., serum calcium ≥ 12 mg\u002FdL (3.0 mmol\u002FL) corrected for albumin\n13. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n14. Pregnant or breastfeeding females.\n15. Body surface area (BSA) \\\u003C1.4 m2 at baseline, calculated by the Dubois or Mosteller method.\n16. Life expectancy of less than 3 months.\n17. Major surgery within 4 weeks prior to C1D1.\n18. Active, unstable cardiovascular function, as indicated by the presence of:\n\n    1. Symptomatic ischemia, or\n    2. Uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmic are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block will not be excluded), or\n    3. CHF of New York Heart Association Class ≥3 or known left ventricular ejection fraction \\\u003C 40%, or\n    4. Myocardial infarction (MI) within 3 months prior to C1D1 or\n    5. Stroke and other thrombosis, such as, pulmonary embolism (PE) or deep vein thrombosis (DVT) within 3 months prior to C1D1.\n19. Any active GI dysfunction interfering with the patient's ability to swallow tablets, or any active GI dysfunction that could interfere with absorption of study treatment.\n20. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia\u002Fcachexia (palliative care).\n21. Any active, serious psychiatric, medical, or other conditions\u002Fsituations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.\n22. Contraindication to any of the required concomitant drugs or supportive treatments.\n23. Patients unwilling or unable to comply with the protocol.",{"count":5,"type":22},[63],"Selinexor, a first-in-class, oral selective exportin 1 (XPO1) inhibitor, has shown promise in pre-clinical and clinical studies. It functions by inhibiting the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins and inhibition of oncoprotein mRNAs, which is selectively lethal to myeloma cells. Selinexor has demonstrated activity in combination with various drugs, including glucocorticoids and proteasome inhibitors, leading to its FDA approval for the treatment of relapsed or refractory multiple myeloma.",[30,90],[31,90,30],"2025-01-14",{"date":603,"type":45},"2025-01-16",{"date":605,"type":45},"2024-08-06",{"date":607,"type":22},"2027-05-01",{"name":609,"class":179},"Oncotherapeutics",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":421},"100524930","phase-2-a-study-of-venetoclax-in-combination-with-isatuximab-and-dexamethasone-for-relapsedrefractory-multiple-myeloma-100524930","NCT06115135","A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed\u002FRefractory Multiple Myeloma","A Phase 2 Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed\u002FRefractory Multiple Myeloma Patients With t(11;14)","Inclusion Criteria:\n\nSubjects must meet all the following inclusion criteria to be eligible to enroll in this study.\n\n1.Has a diagnosis of MM based on standard criteria as follows: Myeloma Criteria: Must be At least 1 of 2\n\n1. Clonal bone marrow plasma cells \\>10%\n2. Biopsy-proven bony or extramedullary plasmacytoma\n\nActive Myeloma criteria: Must Meet At Least ONE of the Following:\n\nMeet at least one of the sub-criteria for #1 Evidence of End Organ Damage (a, b, c, or d), OR Meet sub-criteria #2. 60% or greater bone marrow plasma cells, OR Meet sub-criteria #3 Serum free light chain ratio, OR Meet sub-criteria #4 More than one focal lesion on MRI \\> 5mm in size.\n\n1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically\n\n   1. Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1mg\u002FdL) higher than the upper limit of normal or \\>2.75 mmol\u002FL (\\>11mg\u002FdL)\n   2. Renal insufficiency: creatinine clearance \\\u003C40 mL per minute or serum creatinine \\>177mol\u002FL (\\>2mg\u002FdL)\n   3. Anemia: hemoglobin value of \\>20g\u002FL below the lowest limit of normal, or a hemoglobin value \\\u003C100g\u002FL\n   4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET\u002FCT. If bone marrow has \\\u003C10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement\n2. 60% or greater clonal plasma cells on bone marrow examination\n3. Serum involved \u002F uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg\u002FL (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)\n4. More than one focal lesion on MRI that is at least 5mm or greater in size The patient must have met the criteria for Active Myeloma at some stage following the diagnosis of Myeloma. Source documentation for both Myeloma and Active Myeloma will be required.\n\n2\\. Currently has MM with measurable disease, defined as:\n\n1. a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g\u002FdL and\u002For urine monoclonal protein levels of at least 200 mg\u002F24 hours\n2. for patients without measurable serum and urine M-protein levels, an involved SFLC \\> 100 mg\u002FL or abnormal SFLC ratio\n3. for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 1500 mg\u002FL or meet other measurable disease eligibility criteria\n\n   3\\. Show the (11;14), as demonstrated by FISH or cytogenetic analysis at screening or at any point prior to screening. If performed more than 45 days prior, it should be repeated at the investigator's discretion.\n\n   4\\. Absolute neutrophil count ≥ 1.5 x 109\u002FL 5. Platelet count ≥ 75 x 109\u002FL 6. Hemoglobin ≥ 8.0 g\u002FdL within 21 days prior to enrollment. 7. Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL\u002Fminute as calculated by Cockcroft-Gault method 8. Total bilirubin levels ≤ 2.0 mg\u002FdL (normal levels) 9. AST (SGOT) and ALT (SGPT) ≤ 2 x ULN 10. Serum potassium 3.0-5.5 mEq\u002FL 11. Female of childbearing potential (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 and again within 24 hours of starting and must either commit to continued abstinence from heterosexual intercourse or use acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, and at least 28 days before she starts taking treatment drugs. 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 vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Contraception measures should be continued for 3 months following the treatment completion.\n\n   †A FCBP (female of childbearing potential) is 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 (i.e., has had menses at any time in the preceding 24 consecutive months 12. Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 2 13. Participant must have received at least 1 prior line of therapy for multiple myeloma, including a proteasome inhibitor, lenalidomide, and glucocorticosteroids but not necessarily in one treatment regimen 14. Participant currently has documented progressive MM per IMWG criteria\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Participant has a history of intolerability to any of the study drugs\n2. Participant has any of the following conditions: amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known human immunodeficiency viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of screening, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to screening, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to screening, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to screening, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study\n3. Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study\n4. If participant had prior allogeneic stem cell transplant (SCT), participant has evidence of ongoing graft-versus-host disease (GvHD)\n5. Participants that are pregnant or breast feeding\n6. Participants with hypersensitivity to any study medications and\u002For their excipients\n7. Treatment with an anti-CD38 antibody (daratumumab or isatuximab) within the last 3 weeks\n8. For those patients treated with an anti-CD38 antibody (daratumumab or isatuximab), alone or in combination, without achieving a best response of at least MR\n9. Treatment with venetoclax\n10. Treatment with any of the following prior to the first dose of study drug:\n\n    1. Chemotherapy within 3 weeks of starting study drugs\n    2. Corticosteroids (\\>20 mg per day prednisone or equivalent) within 3 weeks of starting study drugs\n    3. Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs\n    4. Extensive radiation therapy within 28 days of starting study drugs. Receipt of localized radiation therapy does not preclude enrollment\n    5. Use of any other experimental drug or therapy within 28 days of starting study drugs\n    6. Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 7 days of starting study drugs\n11. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n    1. Grapefruit or grapefruit products\n    2. Seville oranges (including marmalade containing Seville oranges)\n    3. Star fruit\n12. Additional prior and concomitant therapy excluded and cautionary medications:\n\n    a. Excluded: i. Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small molecule agents: Excluded 5 half-lives prior to first dose and throughout venetoclax administration ii. Biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent: Excluded 21 days prior to first dose and throughout venetoclax administration\n13. Cautionary during the study:\n\n    1. Strong and Moderate CYP3A inhibitors: Exclude during ramp-up phase and consider alternative medications. If the subject requires use of these medications at the cohort designated dose, use with caution and reduce the venetoclax dose by 50% for moderate inhibitors and at least 75% for strong inhibitors during co-administration. After discontinuation of CYP3A inhibitor, wait for 2 to 3 days before venetoclax dose is increased back to the initial maintenance\u002Ftarget dose.\n    2. Strong and Moderate CYP3A inducers: Exclude during ramp-up phase and consider alternative medications. If the subject requires use of these medications at the cohort designated dose, use with caution and contact medical monitor for guidance.\n    3. Additional: Warfarin, P-gp substrates, BCRP substrates, OATP1B1\u002F1B3 substrates, P-gp inhibitors, BCRP inhibitors",{"count":618,"type":22},39,[25],"A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed\u002Frefractory multiple myeloma patients with t(11;14)",[30,90],[31,33,34,623],"Relapsed\u002FRefractory Multiple Myeloma",{"date":603,"type":45},{"date":626,"type":45},"2024-06-20",{"date":148,"type":22},{"name":609,"class":179},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":77},"100481263","phase-1-lmy-920-for-treatment-of-relapsed-or-refractory-myeloma-100481263","NCT05546723","LMY-920 for Treatment of Relapsed or Refractory Myeloma","LUMT1A22, Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Myeloma (LMY-920-002)","LMY-920-002","Inclusion Criteria:\n\n1. Subjects must have histologically confirmed myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Failing line of therapy is defined accordingly to International Myeloma Workshop Consensus Panel.\n2. No evidence of CNS myeloma.\n3. Male or female \\> 18 years of age.\n4. ECOG Performance status ≤ 2.\n5. Has measurable disease at the time of enrollment as defined by at least one of the following:\n\n   * Serum M-protein greater or equal to 0.5g\u002FdL\n   * Urine M-protein greater or equal to 200mg\u002F24hr\n   * Serum free light chain (FLC) assay: involved light chain greater or equal to 10mg\u002FdL provided serum FLC ratio is abnormal\n   * Bone marrow plasma cells greater than or equal to 30% total bone marrow cells\n6. \\>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.\n7. Total bilirubin ≤ 1.5 mg\u002FdL (except in patients with Gilbert's syndrome).\n8. AST (SGOT)\u002FALT ≤ 2.5 X institutional upper limit of normal.\n9. Serum creatinine \\\u003C 2 mg\u002FdL.\n10. Cardiac ejection fraction of \\>45%, and no evidence of pericardial effusion, as determined by an echocardiogram.\n11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.\n14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n1. ASCT within 6 weeks of informed consent.\n2. History of allogeneic hematopoietic stem cell transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by myeloma. Subjects with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.\n5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n7. New York Heart Association class IV congestive heart failure.\n8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n9. Active infection requiring intravenous systemic treatment.\n10. HIV seropositivity.\n11. Pregnant or breastfeeding women are excluded from this study because LMY-920 therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with LMY-920, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n12. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n13. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n15. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n16. Known additional malignancies which require systemic treatment.\n17. History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.",{"count":5,"type":22},[63],"Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma.",[90,30],[218,307,642],"BAFF ligand","2024-10-16",{"date":645,"type":45},"2024-10-18",{"date":647,"type":45},"2024-03-13",{"date":649,"type":22},"2025-10-31",{"name":651,"class":179},"Luminary Therapeutics"]