[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapse-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapse-multiple-myeloma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,40,67,92,111,135,159,182,203,225,255,277,303],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100641132","study-to-evaluate-efficacy-and-safety-of-belantamab-based-combinations-for-relapsed-multiple-myeloma-100641132",false,"NCT07637526","Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma","Retrospective Observational Study to Evaluate the Effectiveness and Safety of Belantamab Mafodotin-based Combinations (Belantamab Mafodotin, Bortezomib, Dexamethasone [BVd] or Belantamab Mafodotin, Pomalidomide, Dexamethasone [BPd]) Used as Compassionate Use in Patients With Multiple Myeloma in First or Second Relapse","GEM-BELACOMBOS","Inclusion Criteria:\n\n* Confirmed diagnosis of relapsed\u002Frefractory MM.\n* Having received at least one dose of a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions as treatment for a first or second relapse.\n* Patients ≥18 years of age at the start of treatment with the belantamab mafodotin combination (BVd or BPd) under compassionate use conditions.\n\nExclusion Criteria:\n\n* Any patient who has received a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions in fourth line of treatment or later will be excluded from the study.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The goal of this retrospective observational study is to characterize multiple myeloma (MM) patients (by collecting demographics, disease characteristics and treatment history data) treated in first or second relapse with belantamab mafodotin combinations under compassionate use conditions.",[25],"Relapse Multiple Myeloma",[27],"belantamab mafodotin","NOT_YET_RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":21},"2026-06-01",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"PETHEMA Foundation","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100629846","phase-1-study-of-selinexor-with-carfilzomib-isatuximab-and-dexamethasone-for-patients-with-relapsed-andor-refractory-multiple-myeloma-100629846","NCT07479979","Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and\u002For Refractory Multiple Myeloma","Phase Ib\u002FII Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and\u002For Relapsed Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \\>2 will be allowed only if it is related to bone pain that is expected to improve with treatment.\n4. Patients with a diagnosis of relapsed or relapsed\u002Frefractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will specifically enrich for patients with 1q gain or amplification as well as other IMWG high-risk features with the aim of including ≥50% of the enrolled population (a minimum of 25 patients) with high risk disease. High risk disease is defined as the presence of:\n\n   * del(17p), with a cutoff of \\>20% clonal fraction, and\u002For TP53 mutation\n   * an IgH translocation including t(4;14), t(14;16), or t(14;20) along with 1q+ and\u002For del(1p32)\n   * monoallelic del(1p32) along with 1q+ or biallelic del(1p32)\n   * β2 microglobulin ≥5.5 mg\u002FL with normal creatinine (\\\u003C1.2 mg\u002FdL) For purposes of the study, patients with 2 or more of these high risk cytogenetic abnormalities. Patients known to carry such abnormalities on previous FISH analysis and\u002For cytogenetic testing will also be eligible, if results from on-study marrow are unavailable or not obtainable. Therefore, enrollment of patients without these feature(s) will halt once 25 standard risk, non-mutated patients are enrolled and treated. Refractory is defined as patients relapsing on or within 60 days of therapy, per IMWG.\n5. Patients must have measurable disease as defined by at least one of the following:\n\n   1. A monoclonal protein (M-protein): ≥ 0.5g\u002FdL on serum protein electrophoresis or ≥ 200 mg of monoclonal protein on a 24-hour urine protein or involved serum light chain ≥ 10 mg\u002Fdl at time of relapse, or\n   2. Biopsy proven plasmacytoma that can be assessed by physical exam or imaging, or\n   3. If non- or oligo secretory, ≥10% plasma cells on BM biopsy\u002Faspirate at time of relapse or plasmacytoma as described and\u002For evaluable disease by positron emission tomography, either MR or CT. Patients must be willing to undergo repeat BM aspirate and biopsy to assess response.\n   4. Due to the difficulty of quantitation using conventional SPEP of IgA and IgD monoclonal proteins, an absolute increase of \\> 25 % over previous nadir of the total values in mg\u002Fdl (or adjusted units) will meet eligibility requirements for progression and study eligibility.\n\n   NOTE: Urine protein electrophoresis (UPEP) (on a 24-h collection) is required at baseline; no substitute method is acceptable. Urine must be assessed to establish response if the baseline urine M-spike is ≥ 200 mg\u002F24 h. Please note that if both serum and urine M-components are present at the time of enrollment, both should be assessed in order to evaluate response for CR but monthly 24 hour urine tests outside of this response testing are not necessary. For patients without a monoclonal urine protein ≥200mg\u002F24 hours, the test only needs to be repeated to corroborate CR.\n6. Patients may have received any number and type of previous treatments for myeloma including carfilzomib and an anti-CD38 antibody but cannot be refractory to the combination of daratumumab and carfilzomib.\n7. Patients may not have received any anti-CD38 therapy within 6 months of start of study treatment (not enrollment).\n8. Previous allogeneic transplant is allowed provided the patient is not receiving ongoing systemic therapy for graft-versus-host disease (GVHD).\n9. Previous B-cell maturation antigen (BCMA)-directed therapy, including chimeric antigen receptor T-cell therapy (CAR-T) transplantation, antibody drug conjugates, or bispecific engagers is also allowed, provided there is no evidence of residual cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome. In addition, other T cell redirecting therapy exposure is permitted as well.\n10. Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n    * White blood cell (WBC): ≥ 1,500\u002Fmm3\n    * Absolute Neutrophil Count (ANC): ≥ 1,000\u002Fmm3 a (For subjects with known Duffy null phenotype (benign ethnic neutropenia), the lowest acceptable ANC will be 750\u002Fmm3)\n    * Platelet Count: ≥75,000\u002Fmm3\n    * Hemoglobin (Hgb): ≥ 8 g\u002FdL\n    * Calculated creatinine clearance: ≥ 20 cc\u002Fmin using the Cockcroft-Gault formula\n    * Total Bilirubin: ≤ 2 × upper limit of normal (ULN) (except patients with suspected Gilbert's syndrome \\[hereditary indirect hyperbilirubinemia\\] who must have a total bilirubin of ≤ 3x ULN)\n    * Aspartate aminotransferase (AST): ≤ 3 × ULN\n    * Alanine aminotransferase (ALT): ≤ 3 × ULN\n11. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 7 days prior to registration.\n12. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). Male participants must agree not to donate sperm during this same time period.\n13. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n14. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment and absolute lymphocyte count is ≥ 350\u002Ful. Such subjects may stay on antiviral therapy during study treatment.\n15. Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection may be enrolled if the viral load by PCR is undetectable with\u002Fwithout active treatment. Such patients may stay on viral therapy while on treatment. Due to a potential HBV and HepC reactivation risk with carfilzomib, the subjects are required to have HBs Ag and HBc Ab screening.\n16. Subject willing to provide mandatory bone marrow biopsy and peripheral blood laboratory testing for research purposes only.\n\nExclusion Criteria:\n\n1. Active infection requiring systemic therapy (Note: subjects can be enrolled if they will be completing antibiotic therapy by the time of actual start date of treatment)\n2. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n3. Known additional malignancy that is active and\u002For progressive, requiring urgent or new treatment. Exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, prostate cancer on stable hormonal therapy, DCIS or other cancer for which the subject has been disease-free for at least three years. Patients who have undergone a curative procedure for another malignancy are eligible.\n4. Active central nervous system (CNS) metastases. NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.\n5. History of severe hypersensitivity reaction (grade 3 or more) to an anti-CD38 antibody that in the opinion of the investigator excludes the use of these drugs.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III and IV), unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Treatment with any investigational drug within 14 days prior to registration.\n8. Any previously active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment. This is likely to be a rare occurrence.\n9. Treatment with moderate or strong inhibitors\u002Finducers of CYP3A within 7 days prior to Day 1 of Cycle 1. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, and St. John's Wort. For patients receiving diltiazem or verapamil, alternative therapy will need to be substituted, if necessary, if the drug cannot otherwise be safely discontinued.\n10. Currently receiving a strong CYP3A4 inhibitor\u002Finducer and unable to discontinue such medications.\n11. Prior exposure to a SINE compound, including selinexor.\n12. Exposure to anti-CD38 directed therapy (ex. daratumumab; isatuximab; daratumumab\u002Fhyaluronidase) within 6 months of study registration.\n13. Patients with an echocardiogram or other cardiac imaging study showing a LVEF of \\\u003C40% within 60 days of study registration.\n14. Presence of plasma cell leukemia at time of registration\n15. Patients with a history of POEMS syndrome or primary AL amyloidosis are excluded",{"count":48,"type":21},62,"INTERVENTIONAL",[51,52],"PHASE1","PHASE2","The primary objective of this Phase Ib\u002FII trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed\u002Frefractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.",[25,55],"Refractory Multiple Myeloma","RECRUITING","2026-05-12",{"date":59,"type":32},"2026-05-14",{"date":61,"type":21},"2026-07",{"date":63,"type":21},"2029-07",{"name":65,"class":39},"Natalie Callander",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":49,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":66},"100621962","phase-1-dcmm-fusion-vaccine-with-bcma-car-t-in-rr-mm-100621962","NCT07377435","DC\u002FMM Fusion Vaccine With BCMA CAR-T in R\u002FR MM","Phase I Study of Vaccination With DC\u002FMM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma\n* Patients must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment.\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients receiving other investigational drugs\n* Patients with Plasma Cell Leukemia\n\n  * Patients who have known active uncontrolled infections with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)\n  * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding.\n* Prior organ transplant requiring immunosuppressive therapy.\n* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of intolerance to CAR-T related drugs or GM-CSF.\n\nInclusion Criteria Prior to Vaccination with DC\u002FMM Fusions:\n\n* Resolution of all CAR T- related grade 3-4 toxicities\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells\n* Absence of disease progression following CAR T-cell therapy\n* ECOG performance status ≤ 2\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine within normal limits or Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n  * ANC \\>1000 in the absence of growth factor support in the prior 7 days\n  * Platelet count \\>50K without the need for transfusion in the prior 7 days\n  * No myeloma-directed therapy following administration of CAR T-cells",{"count":75,"type":21},25,[51],"This study is to evaluate the safety and effectiveness of dendritic cell DC\u002FMM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed\u002Frefractory multiple myeloma.\n\nThe names of the study drugs involved in this study are:\n\n* DC\u002FMM fusion vaccine (a type of personalized cancer vaccine)\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)",[79,55,25],"Multiple Myeloma",[79,55,81,82],"Relapsed Multiple Myeloma","MM","2026-05-04",{"date":85,"type":32},"2026-05-08",{"date":87,"type":32},"2026-01-30",{"date":89,"type":21},"2032-03-01",{"name":91,"class":39},"David Avigan",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":49,"phases":99,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100577494","phase-1-a-phase-1-study-of-vaccination-with-dendritic-cell-dcmultiple-myeloma-mm-fusions-in-combination-with-elranatamab-in-relapsed-or-refractory-multiple-myeloma-100577494","NCT06799026","A Phase 1 Study of Vaccination With Dendritic Cell (DC)\u002FMultiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma","Inclusion Criteria for Tumor Collection:\n\n* Participants must have an established diagnosis of multiple myeloma\n* Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy\n* Participants must have at least 3 prior lines of therapy\n* Participants must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have \\> 20% plasma cells in the bone marrow core or aspirate differential \\\u003C30 days prior to enrollment.\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin ≤1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Tumor Collection:\n\n* Patients who are receiving any other investigational agents.\n* Patients with purely non-secretory MM \\[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \\>100 mg\u002FL\\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.\n* Patients with Plasma Cell Leukemia\n* Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).\n* Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Active and clinically significant autoimmune or inflammatory disorder requiring active treatment\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding\n* Prior organ transplant requiring immunosuppressive therapy.\n* Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n\nEligibility Criteria Prior to Vaccination with DC\u002FMM fusions\n\n* Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary.\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine\n* Absence of disease progression following 2 cycles of elranatamab therapy\n* ECOG performance status ≤ 2\n\nParticipants must have adequate organ function as defined below:\n\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal\n* AST ≤ 3 x institutional upper limit of normal\n* ALT ≤ 3 x institutional upper limit of normal\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal",{"count":75,"type":21},[51],"This research is being done to determine if the combination of the Dendritic Cell (DC)\u002F Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).\n\nThe names of the study drugs and vaccine involved in this study are:\n\n* DC\u002FMM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)\n* Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)\n* Elranatamab (a type of T-cell engager antibody)",[79,25,55],[82,79,25,55],{"date":104,"type":32},"2026-05-07",{"date":106,"type":32},"2025-01-31",{"date":108,"type":21},"2030-09-01",{"name":91,"class":39},2,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":49,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":66},"100609934","phase-1-ft836-car-t-cell-therapy-in-combination-with-daratumumab-in-patients-with-relapsed-andor-refractory-multiple-myeloma-100609934","NCT07221032","FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must ≥18 years and \\\u003C 80 years old.\n2. Patients must have received \\>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:\n\n   • International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy.\n3. Patients must have measurable disease, including at least one or more of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002Fdl;\n   2. Urine M-protein ≥ 200 mg\u002F24 hrs;\n   3. Involved serum light chain ≥100 mg\u002FL with abnormal light chain ratio;\n4. Karnofsky performance score ≥70.\n5. Adequate hepatic function, defined as:\n\n   1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C3x upper limit of normal (ULN);\n   2. Serum bilirubin \\\u003C2.0 mg\u002FdL except for patients with Gilbert's syndrome, who must have serum bilirubin of \\\u003C3 mg\u002FdL.\n6. Absolute neutrophil count (ANC) ≥1,000 with no G-CSF within 72 hours or pegylated G-CSF within 10 days.\n7. Platelets ≥50,000 with no transfusion within 72 hours of eligibility testing.\n8. Adequate renal function, defined as creatinine clearance ≥50 mL\u002Fmin calculated using the Cockroft-Gault formula.\n9. Able to provide written informed consent.\n10. Agree to practice birth control during the study.\n11. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.\n12. Expected survival \\>12 weeks.\n13. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n14. No contraindication to central line access. Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of the eligibility criteria. Lactating women are eligible for this study but will be asked not to provide breast milk to their child from Day -11 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double-barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.\n\nExclusion Criteria:\n\n1. Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.\n6. Refusal to participate in the long-term follow-up protocol.\n7. Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before start of daratumumab and a remission documented within four weeks of planned CAR T-cell infusion by MRI brain and Cerebrospinal Fluid (CSF) analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.\n10. Prior treatment with gene therapy or any gene-modified cellular therapy.\n11. Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of starting daratumumab or after starting daratumumab.\n\n    1. Corticosteroids are allowable up until seven days prior to starting daratumumab and after starting daratumumab for disease control up until the day prior to cell infusion (Day -1).\n    2. Radiation is allowed to a single symptomatic site.\n12. Patients post solid organ transplant who develop high-grade lymphomas or leukemias.\n13. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n14. Active bacterial, viral, or fungal infection requiring systemic treatment.\n15. Patients who have received major surgery one week prior to starting daratumumab and three weeks prior to lymphodepletion.\n16. Active malignancy that required therapy in the last two years except successfully treated non-metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.","80 Years",{"count":120,"type":21},12,[51],"This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and\u002For refractory myeloma who have failed prior therapies.",[25,55],[125,126],"multiple myeloma","CAR-T therapy","2026-04-09",{"date":129,"type":32},"2026-04-14",{"date":61,"type":21},{"date":132,"type":21},"2030-03",{"name":134,"class":39},"Medical College of Wisconsin",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":49,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100526709","phase-2-elranatamab-in-rr-multiple-myeloma-100526709","NCT06138275","Elranatamab in R\u002FR Multiple Myeloma","A Phase 2 Study of Elranatamab as Consolidation After Idecabtagene Vicleucel in Relapsed Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n* Male or female participants age ≥ 18 years\n* The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.\n* Prior diagnosis of MM as defined according to IMWG criteria.\n* Measurable disease of multiple myeloma as defined by at least one of the following prior to idecabtagene vicleucel infusion:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\n  * Serum free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free kappa to serum free kappa light chain ratio (\\\u003C0.26 or \\>1.65)\n* Previously treated relapsed and refractory multiple myeloma following idecabtagene vicleucel as infusion as standard of care who have achieved at least a PR or better per IMWG criteria. Patients will have received idecabtagene per label including after at least 4 prior lines of therapy and relapsed after an immunomodulatory drug (IMiD), a proteasome inhibitor and an Anti-CD38 monoclonal antibody\n* left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gated acquisition scan (MUGA) scan or echocardiogram (ECHO).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000\u002Fmicrolitre (mcL). Use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing.\n  * Platelet count ≥25,000\u002FmcL. Platelet transfusion support is permitted if completed at least 7 days prior to planned start of dosing.\n  * Hemoglobin ≥8 g\u002FdL. Red blood cell transfusion support is permitted if completed at least 7 days prior to planned start of dosing.\n  * Calculated creatinine clearance ≥30 mL\u002Fmin by Cockcroft-Gault equation.\n  * Patient has adequate hepatic function, as evidenced by each of the following:\n\n    * Serum total bilirubin \\\u003C2 mg\u002FdL; and\n    * Serum aspartate transaminase (ALT) and\u002For aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin).\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n\nExclusion Criteria:\n\n* Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.\n* Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).\n* Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:\n\n  * Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);\n  * Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\] or pulmonary embolism);\n  * Prolonged QT syndrome (or triplicate average QTcF \\>470 msec at screening).\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n* Ongoing Grade ≥2 peripheral sensory or motor neuropathy.\n* History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n* Previous treatment with an anti-BCMA (B-cell maturation antigen) bispecific antibody.\n* Pregnant women are excluded from this study because elranatamab is an anti-BCMA bispecific antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.\n\nKnown or suspected hypersensitivity to the study intervention or any of its excipients.\n\nParticipants who are receiving any other investigational agents for this condition (if appropriate only).\n\nLive attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention.\n\nToxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.\n\nOther surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\nPrevious administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).",{"count":143,"type":21},32,[52],"This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.",[55,25,79],[148],"relapsed\u002Frefractory multiple myeloma","2026-03-11",{"date":151,"type":32},"2026-03-13",{"date":153,"type":32},"2024-03-08",{"date":155,"type":21},"2028-12-01",{"name":157,"class":39},"Massachusetts General Hospital",3,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":49,"phases":168,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":66},"100620545","novel-cd19bcma-dual-targeted-car-t-cell-therapy-for-the-treatment-of-relapsedrefractory-multiple-myeloma-100620545","NCT07359014","Novel CD19\u002FBCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Multicenter Clinical Study of Novel CD19\u002FBCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Relapsed\u002Frefractory multiple myeloma.\n2. Confirmed by immunohistochemistry (IHC) or flow cytometry of bone marrow samples: plasma cell membrane expression of BCMA is positive (≥30%); no requirement for CD19 positivity rate. All sites must centrally submit bone marrow or plasmacytoma biopsy specimens to the lead site's pathology department or bone marrow\u002Fliquid specimens to KingMed Diagnostics (third-party laboratory) for BCMA expression verification.\n3. Relapsed\u002Frefractory patients must meet the following criteria:\n\n   No response or disease progression after 3 cycles of bortezomib (proteasome inhibitor) or lenalidomide therapy No response or disease progression after 3 cycles of prior treatment regimen Interval between last treatment and disease progression \\>30 days No current indication for hematopoietic stem cell transplantation (HSCT), or patient refusal of HSCT\n\n   Definition of disease progression follows the 2021 International Myeloma Working Group (IMWG) criteria, meeting at least one of the following:\n\n   Serum M protein ≥ 5 g\u002FL Urine M protein ≥ 200 mg\u002F24 h If serum free light chain (FLC) ratio is abnormal, patient FLC level ≥ 100 mg\u002FL Biopsy-confirmed evaluable plasmacytoma Increased myeloplasmacytic percentage ≥25% (absolute increase ≥10%) Myeloplasm cells constitute ≥30% of total bone marrow cells\n4. Expected survival \\>12 weeks;\n5. Disease status is evaluable and meets at least one of the following:\n\n   Serum M-protein ≥10 g\u002FL, 24-hour urine M-protein ≥ 200 mg, Serum FLC ≥ 50 mg\u002FL, Plasmacytoma evaluable by imaging or laboratory testing, Bone marrow plasma cell percentage ≥ 30%\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n7. Sufficient venous access for apheresis or venipuncture, with no other contraindications to blood cell separation;\n8. white blood cell (WBC) ≥ 1.5 × 10⁹\u002FL; platelet (PLT) ≥ 45 × 10⁹\u002FL.\n9. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).\n10. Alanine Aminotransferase (ALT) ≤ 2.5 ULN, Aspartate Aminotransferase (AST) ≤ 2.5 ULN.\n\nAll laboratory values within the above ranges must be achieved without ongoing supportive therapy.\n\nExclusion Criteria:\n\n1. Received systemic therapy such as cyclophosphamide and fludarabine for lymphoma clearance within 2 weeks prior to enrollment or single-cell collection; prior CD19\u002FBCMA CAR-T therapy; or cell or bispecific antibody therapy within 8 weeks prior to treatment.\n2. Received bendamustine-containing regimens within 6 months prior to treatment.\n3. Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) positive status; any uncontrolled active infection, including active tuberculosis or Hepatitis B virus (HBV) DNA levels ≥1×10³ copies\u002FmL.\n4. Active infection within 72 hours prior to treatment initiation; subjects on ongoing prophylactic antibiotics, antifungals, or antivirals are not excluded provided there is no evidence of active infection and the antibiotics are not on the prohibited drug list.\n5. Current systemic use of cyclosporine or steroids such as dexamethasone; recent or current use of inhaled steroids is not exclusionary.\n6. Renal impairment with serum creatinine \\>1.5 times the upper limit of normal (ULN).\n7. Hepatic impairment with AST and\u002For ALT \\>2.5 times ULN and direct bilirubin \\>1.5 times ULN.\n8. Hyponatremia, serum sodium \\\u003C 125 mmol\u002FL.\n9. Baseline serum potassium \\\u003C 3.5 mmol\u002FL (exclusion not applied if potassium supplementation prior to study enrollment restores levels above this threshold).\n10. Pregnant or lactating women.\n11. Other serious conditions that may preclude participation in this trial (e.g., central nervous system disorders, severe heart failure, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, gastric ulcer, active autoimmune disease, etc.).","75 Years",{"count":75,"type":21},[169],"NA","This study aims to investigate the efficacy and safety of CD19\u002FBCMA CAR-T cells in treating relapsed\u002Frefractory multiple myeloma.",[25],[126],"2026-01-13",{"date":175,"type":32},"2026-01-22",{"date":177,"type":32},"2025-11-01",{"date":179,"type":21},"2030-10-31",{"name":181,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":49,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":66},"100600135","phase-1-cilta-talq-fusion-study-a-phase-1b-study-of-talquetamab-bridging-therapy-followed-by-ciltacabtagene-autoleucel-in-patients-with-relapsedrefractory-multiple-myeloma-100600135","NCT07093554","Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.\n3. Have measurable disease, defined as:\n\n   1. Serum M-protein level ≥ 1.0 g\u002FdL, or\n   2. Urine M-protein level ≥ 200 mg\u002F24 hours, or\n   3. In patients without a measurable M-protein, an involved light chain level ≥ 10 mg\u002FdL and an abnormal free light chain ratio.\n4. Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).\n5. Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information.\n6. Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.\n8. Have the following clinical laboratory values at screening:\n\n   Adequate bone marrow function:\n\n   Hemoglobin\\* ≥ 8.0 g\u002FdL; Absolute Neutrophil Count\\* ≥ 1,000\u002FmcL; Absolute Lymphocyte Count\\* ≥ 200\u002FmcL; Platelets\\* ≥ 25,000\u002Fmm\\^3\n\n   \\*Transfusion and growth factor support within 72 hours allowed.\n\n   Adequate hepatic function:\n\n   Total Bilirubin \\\u003C 2 mg\u002FdL; Aspartate aminotransferase (Serum Glutamic Oxaloacetic Transaminase)\u002FAlanine Aminotransferase \\\u003C 5 times institutional upper limit\n\n   Adequate renal function:\n\n   Creatinine Clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above institutional normal\n9. Female patients must meet one of the following:\n\n   1. Postmenopausal for at least one year before the screening visit, or\n   2. Surgically sterile, or\n   3. If they are of childbearing potential:\n\n   i. Agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of the study drug, AND ii. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or iii. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n10. Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR\n    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Prior treatment:\n\n   1. Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.\n   2. Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.\n   3. Use of talquetamab prior to enrollment.\n   4. Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and\u002For monoclonal antibodies.\n   5. Prior allogeneic stem cell transplant at any time.\n   6. Autologous stem cell transplant within 2 months of date of enrollment.\n   7. High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date.\n   8. Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date .\n   9. Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.\n   10. A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date .\n   11. Radiation therapy within 7 days of the enrollment date.\n2. No ongoing Grade ≥ 3 non-hematological adverse events from prior therapy.\n3. Active central nervous system (CNS) involvement.\n4. Have plasma cell leukemia (PCL).\n5. Have unmeasurable disease (oligosecretory or non-secretory myeloma).\n6. Have concomitant AL amyloidosis.\n7. Patients with severe cardiac disease.\n\n   1. Active heart disease with New York Heart Association class III or IV congestive heart failure.\n   2. History of myocardial infarction, unstable angina, placement of drug-eluting or metallic stent, coronary artery bypass graft in the last ≤ 6 months.\n   3. Ejection fraction ≤ 40% on transthoracic echocardiography.\n   4. Severe non-ischemic cardiomyopathy.\n8. Patients with pulmonary dysfunction requiring continuous supplemental oxygen ≥ 2L\u002Fminute.\n9. Any serious medical condition such as:\n\n   1. Disabling neurological or psychiatric conditions, including altered mental status, dementia, or any condition that could preclude the use of high-dose steroids and\u002For accurate assessment of neurotoxicity.\n   2. Any condition that could impair the ability of the subject to receive any of the study drugs.\n10. Infections:\n\n    1. No new uncontrolled clinically significant bacterial, viral or fungal infections.\n    2. HIV-positive patients on combination antiretroviral therapy are not eligible.\n11. Pregnant women are excluded from this study because talquetamab and cilta-cel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with talquetamab, breastfeeding should be discontinued if the mother is treated with talquetamab.",{"count":189,"type":21},31,[51],"This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).",[25,55],[194,126,55,25],"Bispecific Antibody","2025-12-30",{"date":197,"type":32},"2026-01-05",{"date":199,"type":32},"2025-12-02",{"date":201,"type":21},"2028-01-01",{"name":134,"class":39},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":49,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":66},"100499903","phase-2-study-of-belantamab-mafodotin-with-carfilzomib-pomalidomide-and-dexamethasone-in-relapsed-multiple-myeloma-100499903","NCT05789303","Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma","Phase II Study of Belantamab Mafodotin in Combination With Carfilzomib, Pomalidomide, and Dexamethasone (KPd) in Patients With Relapsed Multiple Myeloma","1. Subject must be ≥ 18 years of age.\n2. Life expectancy of more than three months.\n3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n4. Subject must have adequate organ function, defined by clinically confirmed lab values set by the study team.\n5. Female Subjects: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n6. Male Subjects: contraceptive should be used consistently with local regulations regarding the methods of contraception for those Subjects in clinical studies. Male Subjects are eligible to participate if they agree to the following during the intervention period and for six months after the last dose of study treatment to allow for clearance of any altered sperm:\n\n   Refrain from donating sperm plus either:\n\n   • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\n   OR\n\n   • Must agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n7. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy.\n8. Subject must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n9. Subject must be willing to comply with the requirements consistent with the belantamab mafodotin and pomalidomide Risk Evaluation and Mitigation Strategy (REMS) programs.\n\n   DISEASE-RELATED:\n10. Subjects with relapsed or refractory multiple myeloma requiring systemic therapy, who have progressed after 2+ prior lines of anti-myeloma treatments. A line of therapy consists of ≥1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.\n11. Subjects may be exposed to lenalidomide, bortezomib, daratumumab, elotuzumab, pomalidomide and\u002For carfilzomib.\n12. If NO prior CAR T-cell therapy: Subjects who have been deemed refractory to EITHER carfilzomib or pomalidomide are permitted but subjects cannot be refractory to both carfilzomib and pomalidomide. Refractoriness is defined here as disease which was non-responsive or progressive while on therapy or within 60 days of the last treatment in patients who had achieved a minimal response or better on prior therapy.\n13. If prior CAR T-cell therapy: Subjects whose most recent line of therapy was anti-B-cell maturation antigen (BCMA) targeted CAR T-cell therapy are permitted to enroll, regardless of carfilzomib\u002Fpomalidomide refractory status, if they meet criteria for progression.\n14. Measurable disease, as indicated by one or more of the following:\n\n    1. Serum M-protein of 0.5 g\u002FdL of greater. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement (i.e. M-spike in the beta region), then quantitative immunoglobulin levels are acceptable (Immunoglobulin-A, Immunoglobulin-M, or Immunoglobulin-D \\> 600 mg\u002FdL or Immunoglobulin-G\\> 1100 mg\u002FdL).\n    2. Urine M-protein ≥ 200 mg\u002F24 hours.\n    3. Involved serum free light chains ≥ 10 mg\u002FdL provided that free light chain ratio is abnormal.\n15. Subjects must receive insurance approval for pomalidomide and dexamethasone.\n\nExclusion criteria\n\nDisease Related\n\n1. Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.\n2. Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).\n3. Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.\n4. Prior refractory status to belantamab mafodotin. Concurrent Conditions\n5. Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.\n6. Subject must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.\n7. Subject must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect Subject's safety). Subjects with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil the inclusion criteria.\n8. Subject must not use contact lenses while participating in this study unless instructed by an ophthalmologist.\n9. Subject must not be simultaneously enrolled in any interventional clinical trial.\n10. Subject must not have had major surgery ≤ 2 weeks prior to initiating study treatment.\n11. Subject must not have any evidence of active mucosal or internal bleeding.\n12. Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of the first dose and\u002For within 14 days before enrollment.\n13. Subject must not have evidence of cardiovascular risk including any of the following:\n\n    1. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. Controlled atrial fibrillation is not an exclusion.\n    2. History of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.\n    3. Class III or IV heart failure as defined by the New York Heart Association functional classification system\n    4. Uncontrolled hypertension.\n14. Subject must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n15. Subject must not have an active infection requiring treatment.\n16. Subject with HIV infection will be excluded unless certain T-cell count, viral load and clinical qualifications are met as confirmed by the study doctor\n\n    Note: consideration must be given to anti-retroviral and prophylactic antimicrobials that may have a drug:drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant.\n17. Patients with Hepatitis B will be excluded unless certain clinical criteria are met as confirmed by the study doctor.\n18. Subject must not have positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment unless the subject can meet the following criteria:\n\n(1) Hepatitis C Ribonucleic acid test is negative (2) Receives successful anti-viral treatment (typically 8 weeks) followed by a negative nucleocapsid ribonucleic acid test after a washout period of at least 4 weeks.\n\nNote: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C test is obtained.\n\n19\\. Subject must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Subjects with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.\n\n20\\. Subject must not have any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with Subject's safety, obtaining informed consent or compliance to the study procedures.\n\n21\\. Subjects must not be pregnant or lactating.",{"count":211,"type":21},83,[52],"Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.\n\nParticipation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.",[79,25],[125],"2025-12-19",{"date":218,"type":32},"2025-12-22",{"date":220,"type":32},"2023-05-30",{"date":222,"type":21},"2028-07-01",{"name":224,"class":39},"University of Chicago",{"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":49,"phases":235,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":66},"100559263","phase-3-study-comparing-therapy-for-advanced-relapsedrefractory-multiple-myeloma-with-and-without-dexamethasone-100559263","NCT06561854","Study Comparing Therapy for Advanced Relapsed\u002FRefractory Multiple Myeloma With and Without Dexamethasone","Free Regimen of Dexamethasone as Initial Therapy for Advanced Relapsed\u002FRefractory Multiple Myeloma: an Open-label Randomized, Non-inferiority, Controlled Trial","FREEDOM","Inclusion Criteria:\n\n1. Adult patients (≥18 years old)\n2. Documented MM in relapse according to standard criteria.\n3. All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan)\n\n   * Eligible for one of the following antibody-based approved combinations:\n\n     1. ICARIA schema: isatuximab, pomalidomide and dexamethasone.\n     2. IKEMA schema: isatuximab, carfilzomib and dexamethasone\n4. Subject must have achieved a response (PR or better) to the prior regimen.\n5. ECOG Performance Status score of 0, 1, or 2.\n6. For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Contraindications to investigational medicinal products or auxiliary medicinal product\n2. Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.\n3. Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib\n4. Allogenic hematopoietic cell transplant (HCT, regardless of timing).\n5. Planned to undergo an hematopoietic cell transplant prior to progression of disease ie, these patients should not be enrolled in order to reduce disease burden prior to transplant.\n6. History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator is considered cured with minimal risk of recurrence within 3 years).\n7. Known MM meningeal Involvement.\n8. Plasma cell leukemia (\\>2.0 × 109\u002FL circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.\n9. Any concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the Investigator would constitute a hazard by participating in this study.\n10. Uncontrolled chronic obstructive pulmonary disease (COPD)\n11. Clinically significant cardiac disease.\n12. Seropositive for hepatitis B with positive PCR\n13. Seropositive for human immunodeficiency virus (HIV) or hepatitis C\n14. Lactation\n15. Participation to another interventional clinical trial\n16. Inability to give written informed consent",{"count":234,"type":21},318,[236],"PHASE3","Patients with relapsed\u002Frefractory symptomatic multiple myeloma who meet all inclusion criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone until disease progression (\"dexamethasone arm\", arm A) or standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment (after 8 weeks) (\"dexamethasone-free arm\", arm B).\n\nIn most centers, IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator, in compliance with each drug's SmPC, but must be performed before randomisation for the purpose of stratification.",[79,25],[240,241,242,243,244,245],"Multiple myeloma","Relapse","Dexamethasone","Isatuximab","Pomalidomide","Carfilzomib","2024-12-13",{"date":248,"type":32},"2024-12-18",{"date":250,"type":32},"2024-12-12",{"date":252,"type":21},"2028-12",{"name":254,"class":39},"Assistance Publique - Hôpitaux de Paris",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":49,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":66},"100457945","phase-1-study-of-car-bcma-a-chimeric-antigen-receptor-t-cell-car-t-therapy-directed-against-bcma-in-subjects-with-multiple-myeloma-100457945","NCT05243212","Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma","A Phase 1\u002F2, Open-Label, Dose Escalation and Confirmation Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n1. Bone marrow plasma cells must be at least 10% of total bone marrow cells based on a bone marrow biopsy\u002Faspiration performed within 30 days of the start of protocol treatment.\n2. Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n3. Subjects must have measurable MM as defined by at least one of the criteria below.\n\n   One or more of these abnormalities defines measurable disease\n   1. Serum M-protein equal or greater than 0.4 g\u002Fdl (10 g\u002Fl).\n   2. Urine M-protein equal or greater than 200 mg\u002F24 h.\n   3. Serum free light chain (FLC) assay: involved FLC level greater or equal to10 mg\u002Fdl (100 mg\u002Fl) provided serum FLC ratio is abnormal.\n   4. A biopsy-proven plasmacytoma\n4. Patients must have received at least 3 prior treatment regimens for multiple myeloma.\n5. Greater than or equal to 18 years of age.\n6. Able to understand and sign the Informed Consent Document.\n7. Clinical performance status of ECOG 0-2\n8. Subjects of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.\n9. Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.\n10. Seronegative for HIV- 1, 2 antibody.\n11. Seronegative for hepatitis B surface antigen (HBsAg) or HBsAg positive with negative PCR for HBV nucleotides in blood. (Treatment to prevent HBV reactivation is standard in any case of seropositivity for HBV).\n12. Seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then subjects must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n13. Syphilis negative.\n14. Absolute neutrophil count greater than or equal to 500\u002Fmm3 without the support of filgrastim or other growth factors.\n15. Platelet count greater than or equal to 30,000\u002Fmm3 without transfusion support\n16. Hemoglobin greater than 8.0 g\u002Fdl.\n17. Less than 5% plasma cells in the peripheral blood leukocytes\n18. At least 14 days must have elapsed since any prior systemic therapy at the time the subject starts the cyclophosphamide and fludarabine conditioning regimen, and subjects' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n19. Systemic anti-myeloma therapy including systemic corticosteroid therapy of greater than 5 mg\u002Fday of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to the required leukapheresis, within 2 weeks prior to CAR T-cell infusion, and for 30 days after the CAR T cell infusion, unless required for treatment of toxicity or other medical need.\n20. Cardiac ejection fraction greater than or equal to 45% by echocardiography within 6 weeks of the start of the treatment protocol.\n\nExclusion Criteria:\n\n1. Subjects with second malignancies in addition to multiple myeloma are not eligible if the second malignancy has required treatment within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma.\n2. Women who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n3. Active systemic infections (defined as infections causing fevers or requiring antimicrobial treatment), or other major uncontrolled medical illnesses.\n4. Active HBV and HCV infection which is identified by positive PCR to viral nucleotides in blood.\n5. Systemic corticosteroid steroid therapy of greater than 5 mg\u002Fday of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.\n6. Inadequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 2 x ULN\n7. Inadequate renal function defined by serum creatinine clearance \u002Festimated clearance of ≤ 20(ml\u002Fmin).\n8. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n9. Subjects with CNS involvement.\n10. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 15 days prior to leukapheresis for CAR T-cell manufacture, or is currently enrolled in an investigational study. However, prior therapy with belantamab mafotodin can be used.",{"count":263,"type":21},75,[51,52],"This is an open label, abbreviated (3+3) dose escalation study in subjects with RRMM, followed by an extension phase at the selected safe dose. The dose escalation stage will involve recruitment of 3 RRMM patients for 'low' dose (6 x 106 CAR-T cells\u002Fkg) CAR-T therapy. After 14 days of follow-up for each of the 3 subjects, the DSC will determine whether the next subject can be recruited.\n\nAfter 14 days follow-up for the 3rd subject, DSC will review data for the 3rd subject and consider the data for the first 3 subjects. In the absence of dose limiting toxicities (DLTs), the DSC may recommend recruitment of 3 subjects to be treated with the 'high' dose (9x106 CAR-T cells\u002Fkg) CAR-T therapy, with similar staggering. In case of DLTs in one of the 3 low dose subjects, the DSC may recommend to recruit an additional 3 low dose subjects (6 in total). If there are no additional DLTs in these 3 patients the low dose may be recommended by the DSC for the extension stage. However, further DLTs may prompt the DSC to recommend to modify the protocol, or to stop the study. In case of DLTs in one of the first 3 high dose subjects, the DSC may recommend to recruit an additional 3 high dose subjects.If there are no additional DLTs in these 3 patients, the high dose may be recommended by the DSC for the study extension stage. However, further DLTs may prompt the DSC to recommend continuation to the extension stage with the low dose, or to modify the protocol, or to stop the study.\n\nAfter completion of two months follow-up for the 6th subject in the low or high dose cohort (as applicable), and review of all the data for all subjects, following DSC recommendations, the Stage 2 extension phase of the study may recruit additional subjects, up to a maximum of 75 subjects for Stages 1 and 2, combined.\n\nDSC will review study data during the extension stage follow-up after 5 years to determine if additional safety follow-up is required.",[79,25],"2024-01-30",{"date":269,"type":32},"2024-01-31",{"date":271,"type":32},"2021-09-19",{"date":273,"type":21},"2028-09-01",{"name":275,"class":276},"Sheba Medical Center","OTHER_GOV",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":284,"maxAge":166,"enrollmentInfo":285,"targetDuration":4,"studyType":49,"phases":287,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":66},"100413935","early-phase-1-a-study-of-humanized-bcma-targeted-car-t-cells-therapy-for-refractoryrelapsed-multiple-myeloma-100413935","NCT04670055","A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory\u002FRelapsed Multiple Myeloma","Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of multiple myeloma (MM):\n\n   1. Patients with BCMA positive relapsed\u002Frefractory MM;\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. Anticipated survival time more than 12 weeks;\n3. Male or female aged 30-75 years;\n4. Those who voluntarily participated in this trial and provided 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.","30 Years",{"count":286,"type":21},50,[288],"EARLY_PHASE1","Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory\u002Frelapsed multiple myeloma",[25,55],[125,292,293],"CAR T-cell therapy","BCMA","2020-12-09",{"date":296,"type":32},"2020-12-17",{"date":298,"type":21},"2021-01-01",{"date":300,"type":21},"2027-01-01",{"name":302,"class":39},"Zhejiang University",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":284,"maxAge":166,"enrollmentInfo":310,"targetDuration":4,"studyType":49,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":66},"100404056","early-phase-1-a-study-of-cs1-targeted-car-t-cells-therapy-for-relapsed-multiple-myeloma-after-bcma-car-t-cells-therapy-100404056","NCT04541368","A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy","Clinical Trial for the Safety and Efficacy of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：\n\n   1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA 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. Anticipated survival time more than 12 weeks;\n3. Male or female aged 30-75 years;\n4. Those who voluntarily participated in this trial and provided 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 hemorrhagicdiseases;\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 infectionand 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 inhaled 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.",{"count":286,"type":21},[288],"Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy",[25],[125,292,315],"CS1",{"date":317,"type":32},"2020-12-10",{"date":319,"type":21},"2020-12-31",{"date":321,"type":21},"2026-12-31",{"name":302,"class":39}]