[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-refractory":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,52,77,104,133,154,175,204,225,250,273,299,323,345,376,398,426,453,473,495,515,538,563,586,611],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"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":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Multiple Myeloma (MM)","Multiple Myeloma Refractory","Multiple Myeloma in Relapse","Multiple Myeloma",[30,32,33,34,35,36,37,38,39],"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":43,"type":44},"2026-06-11","ACTUAL",{"date":46,"type":21},"2026-08",{"date":48,"type":21},"2030-02",{"name":50,"class":51},"SCRI Development Innovations, LLC","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"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":60,"type":21},20,[62],"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.",[28,29],[66],"Liposomal Curcumin","RECRUITING",{"date":69,"type":44},"2026-06-12",{"date":71,"type":44},"2026-02-27",{"date":73,"type":21},"2028-03-02",{"name":75,"class":51},"University Health Network, Toronto",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"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":85,"type":21},52,[62],"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.",[30,29,89],"Multiple Myeloma, Refractory",[91,92,93,94],"Cytokines","Interleukin-7","Cellular therapy","Chimeric antigen receptor T cell therapy","2026-06-07",{"date":97,"type":44},"2026-06-10",{"date":99,"type":44},"2026-06-05",{"date":101,"type":21},"2028-12-31",{"name":103,"class":51},"Washington University School of Medicine",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100643428","why-patients-decline-or-are-being-deemed-ineligible-to-receive-home-based-treatment-a-mixed-methods-study-100643428","NCT07634263","Why Patients Decline or Are Being Deemed Ineligible to Receive Home-based Treatment: a Mixed Methods Study","Inclusion Criteria:\n\n* \\>=18 years old\n* diagnosed Multiple Myeloma or acute leukemia, and recieving treatment with either Daratumumab or Cytarabine.\n\nExclusion Criteria:\n\n\\- Dementia, psychotic disorders, or other cognitive impairments limiting participation.","100 Years",{"count":112,"type":21},50,"OBSERVATIONAL","Treatment for blood cancers has improved significantly, and more patients are now living longer. However, these treatments are often intensive and long-lasting, and many patients experience serious side effects and symptoms. As more patients require ongoing treatment and long-term care, the demand for haematology services is increasing.\n\nHome-based treatment is expected to play an increasingly important role in the future. It can support more patient-centred care, help patients maintain their everyday lives, improve quality of life, and reduce pressure on hospitals. Despite these benefits, some patients are either not eligible for home-based treatment or choose to decline it. The reasons for this are not yet well understood.\n\nThis study combines quantitative data-such as medical information, sociodemographic characteristics, and questionnaire responses about quality of life and health literacy-with qualitative interviews involving patients, relatives, and healthcare professionals. The aim is to identify barriers and differences between patients, and to better understand why some patients opt out of or are unable to participate in home-based treatment.\n\nThe findings will help support the development of more inclusive and patient-centred care models, ensure more equal access to home-based treatment, and improve support for socially vulnerable patients. The results will be shared with patients and families through patient organisations, with hospitals through the Treat@Home programme, and at national and international conferences.",[116,117,28],"Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Multiple Myeloma Progression",[119,120,121,122],"Hematologic Neoplasms","multiple myeloma","Home Care Services","Patient Acceptance of Health Care","2026-06-03",{"date":125,"type":44},"2026-06-08",{"date":127,"type":21},"2026-07-01",{"date":129,"type":21},"2028-06-30",{"name":131,"class":51},"Odense University Hospital",3,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":76},"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":141,"type":21},27,[24],"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.",[29,89],"2026-06-02",{"date":147,"type":44},"2026-06-04",{"date":149,"type":44},"2025-08-22",{"date":151,"type":21},"2027-12-31",{"name":153,"class":51},"Duke University",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100639541","phase-1-exploratory-clinical-trial-of-dq1001-in-relapsed-or-refractory-multiple-myeloma-rrmm-100639541","NCT07622862","Exploratory Clinical Trial of DQ1001 in Relapsed or Refractory Multiple Myeloma (RRMM)","An Early Exploratory Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of DQ1001-a Universal Allogeneic CAR-T Cell Infusion Targeting Both BCMA and GPRC5D-in Patients With Relapsed or Refractory Multiple Myeloma (RRMM).","Inclusion Criteria:\n\n1. Voluntary signing of the Informed Consent Form (ICF) prior to undergoing any study-related procedures.\n2. Age at the time of ICF signing is between 18 and 70 years inclusive.\n3. Diagnosis of relapsed or refractory multiple myeloma (MM), per IMWG criteria:\n\n   * Prior receipt of at least three lines of therapy;\n\n     * Documented progressive disease (PD) during the most recent therapy or within two months after its completion, or documented failure to achieve at least minimal response (MR) within two months after the most recent therapy.\n4. Tumor cells in bone marrow or peripheral blood are BCMA\u002FGPRC5D-positive by flow cytometry; or tumor tissue is BCMA\u002FGPRC5D-positive by immunohistochemistry.\n5. Presence of measurable disease at screening, defined as any one of the following:\n\n   * For IgG-type MM: serum monoclonal M-protein ≥10 g\u002FL; for IgA-, IgD-, IgE-, or IgM-type MM: serum monoclonal M-protein ≥5 g\u002FL; or\n   * Urinary M-protein ≥200 mg\u002F24 h; or\n   * Light-chain MM: involved serum free light chain (FLC) ≥100 mg\u002FL and abnormal serum FLC κ\u002Fλ ratio (\\\u003C0.26 or \\>1.65).\n6. ECOG performance status score of 0-2.\n7. Expected survival ≥12 weeks.\n8. Men with reproductive potential and women of childbearing potential must agree to use effective contraception from the time of ICF signing through two years after the last dose of study drug. Women of childbearing potential include premenopausal women and women within two years of menopause. A negative serum pregnancy test is required at screening for women of childbearing potential.\n9. For patients who previously underwent hematopoietic stem cell transplantation: no active graft-versus-host disease (GVHD), and systemic immunosuppressants discontinued for at least four weeks.\n10. Adequate major organ function, defined as follows:\n\n    * Hematologic: absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL; hemoglobin ≥70 g\u002FL; platelet count ≥50 × 10⁹\u002FL; lymphocyte count \\>0.2 × 10⁹\u002FL;\n    * Coagulation: fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN); prothrombin time (PT) ≤1.5 × ULN;\n    * Hepatic: total bilirubin ≤2 × ULN (≤3 × ULN in patients with Gilbert syndrome); aspartate aminotransferase (AST) ≤3 × ULN; alanine aminotransferase (ALT) ≤3 × ULN;\n    * Cardiopulmonary: left ventricular ejection fraction ≥50%; peripheral capillary oxygen saturation ≥92% without supplemental oxygen, or ≥95% with supplemental oxygen;\n    * Renal: estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m² (calculated using the CKD-EPI equation).\n11. Investigator judgment that the participant is able to comply with protocol requirements and complete treatment and follow-up.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic CNS compression; or a prior history of CNS disorders, including but not limited to epilepsy, hemiplegia, aphasia, stroke, severe traumatic brain injury, dementia, or Parkinson's disease.\n2. Prior treatment with CAR-T therapy or drugs targeting BCMA or GPRC5D.\n3. Active or moderate-to-severe chronic graft-versus-host disease (GVHD) within four weeks prior to signing the informed consent form (ICF), or systemic GVHD-directed therapy within four weeks before the first infusion.\n4. Any investigational drug or systemic antitumor therapy administered within 28 days (or five half-lives of the drug, whichever is deemed more appropriate by the investigator) prior to the first infusion.\n5. Extensive radiotherapy administered within 28 days prior to signing the ICF; localized palliative radiotherapy to non-target lesions is permitted if administered within 14 days prior to signing the ICF or anticipated during the study period.\n6. Major surgical procedure performed within 28 days prior to signing the ICF, or planned major surgery during the study period.\n7. Positive hepatitis B surface antigen (HBsAg) at screening; or negative HBsAg but positive hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody and HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; or positive for both treponemal and non-treponemal antibodies for syphilis.\n8. Known hypersensitivity to any component of the study drugs, including but not limited to lymphodepleting agents (e.g., tocilizumab, cyclophosphamide, fludarabine) or contrast agents used for imaging studies.\n9. Severe respiratory disease (including but not limited to severe or very severe chronic obstructive pulmonary disease, interstitial lung disease); or significant cardiovascular history (including but not limited to coronary artery bypass grafting or percutaneous coronary intervention within six months prior to signing the ICF, myocardial infarction, New York Heart Association \\[NYHA\\] Class III-IV congestive heart failure, unstable angina, corrected QT interval (QTcF) \\> 480 ms, personal or familial history of long or short QT syndrome, uncontrolled severe arrhythmia or hypertension requiring pharmacologic management).\n10. Any comorbidity or other condition judged by the investigator to potentially compromise adherence to the study protocol or render the participant unsuitable for participation in this study.\n11. Pregnant or lactating women, or women planning pregnancy or unwilling to use highly effective, reliable contraception during the study and for two years following completion of study treatment.\n12. Uncontrolled active infection (excluding those viral infections listed above), including but not limited to serious bacterial, fungal, or other viral infections deemed by the investigator to increase the risk associated with study treatment.\n13. Receipt of a live attenuated viral vaccine within one month prior to signing the ICF.\n14. History of immunodeficiency disorder or active autoimmune disease (patients with stable autoimmune disease at enrollment who have not required systemic immunosuppressive therapy for ≥6 months are exempted).\n15. Diagnosis of any malignancy other than multiple myeloma within the past two years prior to screening, except for: malignancies treated with curative intent and without evidence of active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease; or carcinoma in situ treated with curative intent.","70 Years",{"count":163,"type":21},16,[62],"This is a prospective, single-arm, open-label, early exploratory clinical study designed to evaluate the safety, tolerability, and efficacy of the DQ1001 cell product in patients with relapsed or refractory multiple myeloma. All participants will receive intravenous infusions of DQ1001. The study consists of two phases: dose escalation and dose expansion. Following identification of an optimal dose during the dose-escalation phase, the cohort receiving that dose will be expanded to include a total of 12 participants-including those enrolled during dose escalation-to further assess the safety, tolerability, and efficacy of DQ1001.",[28,117],"2026-05-30",{"date":123,"type":44},{"date":170,"type":21},"2026-06",{"date":172,"type":21},"2028-08",{"name":174,"class":51},"Zhongshan Hospital (Xiamen), Fudan University",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":60},"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":184,"type":21},100,[24],"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.",[28,29],[189,190,191,192,193,194],"Inobrodib","Pomalidomide","Pomalyst","Imnovid","Dexamethasone","p300-CBP Transcription Factors","2026-05-29",{"date":145,"type":44},{"date":198,"type":44},"2026-01-22",{"date":200,"type":21},"2029-12-01",{"name":202,"class":203},"CellCentric Ltd.","INDUSTRY",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"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":212,"type":21},12,[62],"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.",[29,89],"2026-05-22",{"date":218,"type":44},"2026-05-28",{"date":220,"type":21},"2026-09-01",{"date":222,"type":21},"2028-12-30",{"name":224,"class":203},"Kure Cells, INC",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":76},"100629687","phase-1-anti-bcma-car--t-cell-therapy-for-adults-with-relapsed-or-refractory-multiple-myeloma-100629687","NCT07477912","Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma","Phase I\u002FII Open-label Study Evaluating The Safety And Efficacy of Anti BCMA CAR-T Cell Therapy in Adults With R\u002F R Multiple Myeloma","MSTH-CAR001","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Willing and able to give written, informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.\n4. Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators.\n5. Adequate organ system function including\n\n   \\- Creatinine clearance ≥30 cc\u002Fmin.\n\n   \\- Serum alanine aminotransferase \u002F aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).\n\n   \\- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.\n\n   \\- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \\[ECHO\\] or\n\n   \\- Baseline oxygen saturation \\>92% on room air and ≤Grade 1 dyspnoea.\n6. Have no active GVHD (Grade 2-4)\n7. Adequate bone marrow (BM) function\n\n   * Absolute neutrophil count ≥1.0 × 10\\^9\u002FL.\n   * Absolute lymphocyte count ≥0.3 × 10\\^9\u002FL (at enrolment and prior to leukapheresis).\n   * Haemoglobin ≥80 g\u002FL.\n   * Platelets ≥50 × 10\\^9\u002FL\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.\n3. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).\n4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.\n5. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.\n6. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 24 months.\n\n6\\. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.\n\n7\\. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).\n\n8\\. The following medications are excluded:\n\n* Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.\n* Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.\n* Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.\n* Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.\n* Live vaccine ≤4 weeks prior to enrolment.\n* Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.\n\nPrior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Prior anti BCMA therapy 10. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.\n\n11\\. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.",{"count":234,"type":21},30,[62,24],"The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma",[28],[239,120],"CAR-T therapy","2026-03-13",{"date":242,"type":44},"2026-03-17",{"date":244,"type":44},"2025-02-01",{"date":246,"type":21},"2030-02-01",{"name":248,"class":249},"Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology","OTHER_GOV",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":161,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"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;",{"count":258,"type":21},24,[62,24],"To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma",[29,28],[263,30,264],"S103","CAR-T","2026-02-11",{"date":267,"type":44},"2026-02-19",{"date":269,"type":21},"2026-02-01",{"date":246,"type":21},{"name":272,"class":203},"Hebei Senlang Biotechnology Inc., Ltd.",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":163},"100394316","phase-2-a-study-of-selinexor-seli--low-dose-dexamethasone-ldd-in-penta-refractory-multiple-myeloma-mm-seli-and-bortezomib--ldd-in-triple-class-refractory-mm-100394316","NCT04414475","A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.","A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age greater than or equal to (\\>=)18 years at the time of signing informed consent.\n* Written informed consent in accordance with federal, local, and institutional guidelines.\n* Measurable MM based on IMWG guidelines as defined by at least one of the following:\n\n  1. Serum M-protein \\>= 0.5 gram per deciliter (g\u002FdL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.\n  2. Urinary M-protein excretion \\>= 200 mg\u002F24 hours.\n  3. Free light chain (FLC) \\>= 100 milligram per liter (mg\u002FL), provided that the FLC ratio is abnormal.\n* Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to protocol version (PV) 5.0: Participants must have relapsed or refractory multiple myeloma (RRMM) and have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 proteasome inhibitors (PIs), at least 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38) monoclonal antibody. Refractory is defined as lesser than or equal to (\\\u003C=) 25 percent (%) response to therapy, or progression during therapy or progression within 60 days after completion of therapy.\n* Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Participants must have RR MM and have been previously treated with \\>=3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to at least 1 drug of each class (PI\u002FIMiD\u002Fanti-CD38). Refractory is defined as \\\u003C=25% response to therapy or progression during therapy or progression within 60 days after completion of therapy.\n* Only for arm SVd: Participants must have previously received 1 to 5 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 1 PI, at least 1 IMiD, and 1 anti- CD38 monoclonal antibody.\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C= 2.\n* Female participants of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.\n\nExclusion Criteria:\n\n* Active plasma cell leukemia.\n* Documented systemic amyloid light chain amyloidosis.\n* Active central nervous system MM.\n* Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade \\>= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant is currently receiving medication.\n* Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including investigational therapies) \\\u003C= 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids are permitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1).\n* Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.\n* Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade greater than (\\>) 2 at C1D1.\n* Inadequate hepatic function defined as total bilirubin \\>= 2x upper limit of normal (ULN) (\\>= 3x ULN for participants with Gilbert's syndrome), aspartate transaminase (AST) \\>= 2.5x ULN, and alanine transaminase (ALT) \\>= 2.5x ULN.\n* Inadequate renal function defined as estimated creatinine clearance of lesser than (\\\u003C) 20 milliliter per minute (mL\u002Fmin), calculated using the formula of Cockroft and Gault.\n* Inadequate hematopoietic function defined as the following:\n\n  1. Absolute neutrophil count (ANC) \\\u003C 1000\u002Fcubic millimeter (mm\\^3)\n  2. Platelet count \\\u003C 75,000\u002Fmm\\^3\n  3. Hemoglobin (Hb) level \\\u003C 8.5 g\u002FdL\n* Life expectancy of \\\u003C 4 months, based on the opinion of the Investigator.\n* Major surgery within 4 weeks prior to C1D1.\n* Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.\n* Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.\n* Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus RNA or hepatitis B virus surface antigen.\n* Female participants who are pregnant or lactating.\n* Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at C1D1.\n* Concurrent therapy with approved or investigational anticancer therapeutic including topical therapies.\n* Prior exposure to a SINE compound, including selinexor.\n* Serious, active psychiatric or active medical conditions which, in the opinion of the Investigator or the Sponsor, could interfere with the participation in the study.\n* Contraindication to any of the required concomitant drugs or supportive treatments.",{"count":281,"type":21},127,[24],"The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.",[89],[30,286,287,288,289],"Selinexor","Penta-refractory Multiple Myeloma","Triple-class Refractory Multiple Myeloma","KPT-330","2026-01-30",{"date":292,"type":44},"2026-02-02",{"date":294,"type":44},"2020-07-01",{"date":296,"type":21},"2028-01",{"name":298,"class":203},"Karyopharm Therapeutics Inc",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":319,"leadSponsor":321,"locationsCount":76},"100600173","phase-4-immunoglobulins-in-multiple-myeloma-patients-receiving-a-bcma-directed-t-cell-engager-100600173","NCT07094048","Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager","CHUQUL_HO001","Inclusion Criteria:\n\n* Multiple myeloma patient:\n* ≥ 18 years old\n* ≥ 1 prior lines of therapy\n* Receiving a BCMA-directed T-cell Engager therapy (starting on treatment)\n* On previous Ig support or not\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Pregancy or breastfeeding",{"count":307,"type":21},80,[309],"PHASE4","Bispecific antibody therapies targeting BCMA (B-cell maturation antigen) represent a novel therapeutic approach for patients with multiple myeloma. They are currently used in cases of refractory multiple myeloma but are also being investigated in earlier lines of treatment. However, these new therapies can lead to deeper immunosuppression and exacerbate an underlying immunosuppressive state in patients with multiple myeloma. As a result, infectious complications are common with these therapies and are a significant concern. Therefore, preventing infections in this population is crucial. However, data on the best strategies for prevention are currently lacking.",[28,312],"Relapsed Multiple Myeloma",[314,30],"Immunoglobulins","2026-01-05",{"date":317,"type":44},"2026-01-07",{"date":315,"type":44},{"date":320,"type":21},"2029-12",{"name":322,"class":51},"CHU de Quebec-Universite Laval",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":76},"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":331,"type":21},6,[333],"NA","This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r\u002Fr multiple myeloma.",[30,29,89],"2025-11-28",{"date":338,"type":44},"2025-12-01",{"date":340,"type":44},"2025-04-10",{"date":342,"type":21},"2028-04-18",{"name":344,"class":203},"Bioray Laboratories",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":353,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":363,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":76},"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":355,"type":21},144,[333],"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.",[29,89,359,117,30,360,361,362],"Multiple Myeloma Stage III","B Cell Lymphoma","Lymphoma, B-Cell","Aggressive Lymphoma",[364,120,365,366,367],"early palliative care","quality of life","symptom management","aggressive lymphoma","2025-11-25",{"date":370,"type":44},"2025-12-03",{"date":372,"type":44},"2024-07-18",{"date":374,"type":21},"2027-06",{"name":75,"class":51},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":396,"locationsCount":76},"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":163,"type":21},[62],"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",[388,389,390,89,29],"Neoplasms","Relapsed Diffuse Large B-cell Lymphoma (DLBCL)","Refractory Diffuse Large B-cell Lymphoma (DLBCL)",{"date":392,"type":44},"2025-08-24",{"date":394,"type":44},"2024-02-15",{"date":374,"type":21},{"name":397,"class":51},"Technische Universität Dresden",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":405,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":76},"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":408,"type":21},60,[62,24],"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",[30,29,117,89],[413,414,415,264,416],"Multiple myeloma","myeloma","Autoimmune Diseases","GPRC5D","2025-06-13",{"date":419,"type":44},"2025-06-22",{"date":421,"type":44},"2025-04-29",{"date":423,"type":21},"2028-12-28",{"name":425,"class":51},"Essen Biotech",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"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":85,"type":21},[24],"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",[438,29,28],"Multiple Myleoma",[30,440,441,442,443],"Relapse","Refractoriness","Teclistamab","Autologous lymphocyte infusion","2025-03-31",{"date":446,"type":44},"2025-04-03",{"date":448,"type":21},"2025-11-01",{"date":450,"type":21},"2029-11-01",{"name":452,"class":51},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":76},"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":5,"type":21},[24],"To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.",[29,89],"2025-02-18",{"date":466,"type":44},"2025-02-19",{"date":468,"type":44},"2023-11-22",{"date":470,"type":21},"2025-12-31",{"name":472,"class":51},"The First Affiliated Hospital of Xiamen University",{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":76},"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":234,"type":21},[62],"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.",[29,89],[30,89,29],"2025-01-14",{"date":488,"type":44},"2025-01-16",{"date":490,"type":44},"2024-08-06",{"date":492,"type":21},"2027-05-01",{"name":494,"class":203},"Oncotherapeutics",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":514},"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":503,"type":21},39,[24],"A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed\u002Frefractory multiple myeloma patients with t(11;14)",[29,89],[30,32,33,508],"Relapsed\u002FRefractory Multiple Myeloma",{"date":488,"type":44},{"date":511,"type":44},"2024-06-20",{"date":151,"type":21},{"name":494,"class":203},2,{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":76},"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":234,"type":21},[62],"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.",[89,29],[120,264,528],"BAFF ligand","2024-10-16",{"date":531,"type":44},"2024-10-18",{"date":533,"type":44},"2024-03-13",{"date":535,"type":21},"2025-10-31",{"name":537,"class":203},"Luminary Therapeutics",{"id":539,"slug":540,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":353,"sex":17,"minAge":18,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":76},"100534701","phase-1-anti-bcma-car-nk-therapy-in-relapsed-or-refractory-multiple-myeloma-100534701","NCT06242249","Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma","Determining Safety and Maximum Tolerated Dose (MTD) of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18-80 years with expected survival \\> 3 months.\n2. Confirmed diagnosis of active multiple myeloma with detectable BCMA expression in malignant cells.\n3. Relapsed or refractory disease with at least 2 prior lines of treatment, including a proteasome inhibitor and immunomodulator, without achieving significant efficacy.\n4. Measurable disease at screening according to IMWG criteria, as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g\u002FdL or urine M-protein level being as defined； or light chain MM without measurable disease in the serum or the urine； serum immunoglobulin free light chain disease dL and abnormal serum immunoglobulin kappa\u002Flambda free light chain ratio\n5. ECOG performance status of 0-1.\n6. Acceptable cardiac, liver, and kidney function.\n7. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Uncontrolled active infection, HIV infection, or positive syphilis serology reaction.\n3. Active hepatitis B or hepatitis C infection.\n4. Recent or current use of glucocorticoids or other immunosuppressors.\n5. Severe cardiac, liver, renal insufficiency, diabetes, or other diseases.\n6. Participation in other clinical research in the past three months.","80 Years",{"count":547,"type":21},10,[62,24],"Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain in terms of antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including BCMA, with CAR-NK cells in multiple myeloma. To further investigate the potential of BCMA-targeted CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard therapy.",[89],[552,553],"CAR-NK Therapy","Anti-BCMA","2024-03-03",{"date":556,"type":44},"2024-03-06",{"date":558,"type":21},"2024-04-30",{"date":560,"type":21},"2026-06-30",{"name":562,"class":51},"Shahid Beheshti University of Medical Sciences",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":17,"minAge":571,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":4},"100509161","phase-2-carfilzomib-oral-cyclophosphamide-and-dexamethasone-for-rrmm-100509161","NCT05909826","Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM","A Phase II Study of Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for Relapsed and\u002For Refractory Multiple Myeloma","KMM-KCd","Inclusion Criteria:\n\n1. Subjects aged 19 years or older\n2. ECOG performance status 0 to 2\n3. Diagnosed with multiple myeloma by IMWG criteria\n4. Subjects previously treated with 1 or more lines of therapy\n5. Subjects previously treated with lenalidomide-based combination or sigle drug therapy\n6. Subjects with relapsed and\u002For refractory multiple myeloma\n7. Subjects with measurable disease at the time of treatment initiation\n\n   * serum M protein \\>=0.5 g\u002FdL, or\n   * 24h urine M protein \\>= 200mg\u002F24h\n   * serum free light chain difference \\>=10mg\u002FdL and abnormal FLC ratio\n8. Adequate organ function\n\n   * absolute neutrophil count \\>= 1.0 x 109\u002FL\n   * platelelt count \\>= 50 x 109\u002FL (plasmacytoma in the bone: \\>=30 x 109\u002FL)\n   * Hb \\>=8g\u002FdL\n   * serum creatinine \\\u003C 3.0mg\u002FdL or CCR \\>=15mL\u002Fmin\n   * serum AST and ALT \\\u003C=3 x ULN\n   * serum total bilirubin \\\u003C= 3 x ULN\n9. Subjects able to swallow oral drugs\n10. Subjects who had experienced toxicities to previous therapies: resolved from previous toxicities or stabilized of the toxicity to grade 1\n11. Subjects who had received allogenetic stem cell transplantation: no acitve graft-versus-host disease\n12. Subjects without clinically relevant bleeding\n13. Subjects who have informed consent to the study\n14. Females of childbearing potential (FCBP) must be negative to pregnancy testing and give consent to practice contraception before and during the treatment\n\nExclusion Criteria:\n\n1\\. Subjects who were previously exposed to carfilzomib\n\n1\\. Subjects who were previously exposed to cyclophosphamide 3. Subjects diagnosed with POEMS SD, Waldenstrom macroglobulinemia, Plasma cell leukemia 4. Subjects with concurrent heart conditions\n\n* Myocardial infarction within 6 months prior to treatment, New York Heart Association class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease,\n* Uncontrolled arrythmias (CVDAE version4 grade 2 or more) or symptomatic EKG abnormalities\n* 12-lead EKG : baseline ATcF \\> 470msec\n* 2D Echocardiography or MUGA scan : systolic EF \\\u003C 40% with clinically significant symptoms\n* Uncontrolled hypertension ( with medication: systolic BP \\>= 160 mmHg or diastolic BP \\>= 100 mmHg) 5. Chronc obstructive pulmonary disease (FEV1 \\\u003C 60%), history of asthma within 2 years 6. Surgery under general anesthesia withing 2 weeks 7. Subjects diagnosed with malignancies within 5 years (except for cured skin cancer, cervical cancer, intraepithelial gastrointestinal tract cancer after curative procedures or surgery for more than 3 years) 8. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent 9. Pregnant or breatfeeding subjecs","19 Years",{"count":573,"type":21},49,[24],"This study aims to study the efficacy and safety of oral cyclophosphamide in addition to carfilzomib and dexamethadone for RRMM patients who have been previously exposed to lenalidomide combination therapies.",[29,89],"2023-06-08",{"date":579,"type":44},"2023-06-18",{"date":581,"type":21},"2023-07-01",{"date":583,"type":21},"2027-06-30",{"name":585,"class":51},"Dong-A University Hospital",{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":607,"leadSponsor":609,"locationsCount":76},"100412999","early-phase-1-april-car-t-cell-therapy-for-patients-with-bcmataci-positive-relapsed-andor-refractory-multiple-myeloma-100412999","NCT04657861","APRIL CAR-T Cell Therapy for Patients With BCMA\u002FTACI Positive Relapsed and\u002For Refractory Multiple Myeloma","Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA\u002FTACI Positive Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of BCMA\u002FTACI+ multiple myeloma (MM)：\n\n   1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA\u002FTACI expression;\n   2. Relapsed after hematopoietic stem cell transplantation;\n   3. Cases with recurrent positive minimal residual disease;\n   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.\n2. Male or female aged 18-75 years;\n3. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 3 months;\n7. ECOG performance status 0 to 2;\n8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;\n7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;\n8. Creatinine\\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study","75 Years",{"count":595,"type":21},36,[597],"EARLY_PHASE1","A study of APRIL CAR-T cells therapy for patients with BCMA\u002FTACI positive relapsed and\u002For refractory multiple myeloma",[29,89],[30,601,602],"CAR T-cell therapy","BCMA\u002FTACI positive","2022-05-03",{"date":605,"type":44},"2022-05-09",{"date":603,"type":44},{"date":608,"type":21},"2027-08-20",{"name":610,"class":51},"Zhejiang University",{"id":612,"slug":613,"hasResults":11,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":161,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":627,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":76},"100408853","early-phase-1-car-t-cells-combined-with-dasatinib-for-patients-with-relapsed-andor-refractory-b-cell-hematological-malignancies-100408853","NCT04603872","CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Hematological Malignancies","Clinical Trial for the Safety and Efficacy of CD19\u002FBCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);\n2. Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):\n\n   1. CR not achieved after standardized chemotherapy;\n   2. CR achieved following the first induction, but CR duration is less than 12 months;\n   3. Ineffectively after first or multiple remedial treatments;\n   4. 2 or more relapses;\n   5. Relapse after hematopoietic stem cell transplantation;\n   6. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;\n3. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol\u002FL;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 12 weeks;\n7. ECOG performance status 0 to 2;\n8. Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.\n9. Patients volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine \\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts, or bilirubin \\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.",{"count":619,"type":21},120,[597],"A Study of CD19\u002FBCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.",[29,89,623,624,625,626],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphocytic Leukaemia Refractory","Non-Hodgkin's Lymphoma, Relapsed","Non-Hodgkin's Lymphoma Refractory",[628,629,30,601,630],"Acute Lymphoblastic Leukemia","Non-Hodgkin's Lymphoma","Dasatinib","2020-10-27",{"date":633,"type":44},"2020-10-28",{"date":635,"type":21},"2020-11-01",{"date":637,"type":21},"2026-11-01",{"name":610,"class":51}]