[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasma-cell-myeloma-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasma-cell-myeloma-refractory":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100411857","phase-1-isatuximab-in-combination-with-novel-agents-in-rrmm---master-protocol-100411857",false,"NCT04643002","Isatuximab in Combination With Novel Agents in RRMM - Master Protocol","Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol","Inclusion Criteria:\n\n* Participant must be 18 years of age inclusive or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line).\n* RRMM with measurable disease:\n\n  * Serum M protein ≥0.5 g\u002FdL measured using serum protein immunoelectrophoresis and\u002For\n  * Urine M protein ≥200 mg\u002F24 hours measured using urine protein immunoelectrophoresis and\u002For\n  * Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg\u002FdL and abnormal serum Ig kappa lambda free light chain ratio \\\u003C0.26 or \\>1.65).\n* Men or woman or childbearing potential should agree to use contraception.\n* Substudy 01, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dose. \"Exposure\" is defined as at least 2 cycles of therapy.\n* Substudies 02, 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. \"Refractory\" is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy.\n* Substudy 04: Anti-CD38 and anti-B cell maturation antigen (BCMA) therapy (if available) prior exposed participants with RRMM. For anti-CD38, \"Exposure\" is defined as at least 2 cycles of therapy. For anti-BCMA therapy if available, exposure is defined by at least 2 cycles of therapy.\n* Substudy 05: Participants with RRMM with at least 2 cycles of prior exposure to anti-CD38 therapy. For participants to whom BCMA targeted therapy is available (ie, approved in their region and can be reimbursed), at least 2 cycles of prior exposure to a BCMA targeted agent is mandatory.\n\nExclusion Criteria:\n\n* Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.\n* Uncontrolled infection within 14 days prior to first study intervention administration.\n* Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction \\\u003C40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0).\n* Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A.\n* Uncontrolled or active hepatitis B virus (HBV) infection.\n* Active hepatitis C virus (HCV) infection.\n* Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease.\n* Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention administration.\n* Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.\n* Participants with a contraindication to treatment.\n* Vaccination with a live vaccine 4 weeks before the start of the study.\n* Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n* Hemoglobin \\\u003C8 g\u002FdL.\n* Platelets \\\u003C50 × 10\\^9\u002FL.\n* Absolute neutrophil count \\\u003C1.0 × 10\\^9\u002FL.\n* Creatinine clearance \\\u003C30 mL\u002Fmin\u002F1.73m2.\n* Total bilirubin \\>1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN.\n* Aspartate aminotransferase and\u002For alanine aminotransferase \\>3 × ULN.\n* Patients with grade 3 or 4 hypercalcemia.\n\nSubstudy 01:\n\n-Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide.\n\nSubstudy 02:\n\n* History of resected\u002Fablated basal or squamous cell carcinoma (SCC) of the skin or carcinoma in situ of the cervix, or other local tumors, even if considered cured by local treatment.\n* Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior to the first dose of SAR439459.\n* Prothrombin time or INR \\>1.5 × upper limit of normal (ULN).\n\nSubstudy 03:\n\n* Current corneal epithelial disease except mild punctate keratopathy.\n* Patients who have received prior therapy with belantamab mafodotin.\n\nSubstudy 04:\n\n* Central nervous system or leptomeningeal disease.\n* Medical history of seizure.\n* Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg, digoxin, warfarin) if cannot be closely monitored.\n* Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), except controlled by replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc). The following are not exclusionary: vitiligo, childhood asthma that has resolved, psoriasis that does not require systemic treatment.\n* Prior allogeneic hematopoietic stem cell transplant (allo-HSCT).\n\nSubstudy 05:\n\n\\- Participant unable to swallow tablets.\n\nSubstudy 06:\n\n* History of active autoimmune disorders.\n* History of autoimmune hemolytic anemia or autoimmune. thrombocytopenia.\n* Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.\n* Prior allogenic hematopoietic stem cell transplant (allo-HSCT).\n* Patient with chronic active EBV infection.\n* Patients with known history of HLH.\n* Hemoglobin \\\u003C 9 g\u002FdL.\n* Prior therapy with any anti-CD47 or anti signal regulatory protein alpha agent.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","18 Years",{"count":19,"type":20},258,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.",[27],"Plasma Cell Myeloma Refractory",[29,30,31,32,33,34,35],"anti-CD38 monoclonal antibody","master protocol","combination therapy","CD38 resistance","interleukin 2","ROCK2 inhibitor","anti-CD47 agent","RECRUITING","2026-10-09",{"date":39,"type":40},"2026-10-13","ACTUAL",{"date":42,"type":40},"2021-01-25",{"date":44,"type":20},"2028-04-20",{"name":46,"class":47},"Sanofi","INDUSTRY",25,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100564563","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-sar446523-injected-subcutaneously-in-adult-participants-with-relapsedrefractory-myeloma-100564563","NCT06630806","A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed\u002FRefractory Myeloma","A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nDose escalation (Part A)\n\n* Participants must have received at least 3 prior lines of antimyeloma therapy, and must be either relapsed or refractory to the above therapies, or are intolerant to them.\n* Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is allowed.\n\nDose optimization (Part B)\n\n* Participants must have received at least 3 prior lines of antimyeloma therapy and be either relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI), anti CD38 monoclonal antibody (mAb), and anti BCMA targeting agent or are intolerant to them.\n* Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.\n\nExclusion Criteria:\n\n-Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.\n\n* Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia. Participants with central nervous system involvement or with clinical signs of meningeal involvement of multiple myeloma.\n* Systemic antimyeloma treatment within 14 days before the first study treatment administration.\n* Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) within 90 days of the first study treatment administration.\n* Inadequate organ and marrow function.\n* Participants with significant concomitant illness.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":57,"type":20},87,[23],"This is a first-in-human study of SAR446523 conducted in patients with RRMM.\n\nThe study consists of two parts:\n\nDose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.\n\nDose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.",[27],[62],"anti-GPRC5D NK cell targeting therapy","2026-03-24",{"date":65,"type":40},"2026-03-25",{"date":67,"type":40},"2024-10-30",{"date":69,"type":20},"2031-05-16",{"name":46,"class":47},19,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100543492","phase-2-a-study-to-investigate-subcutaneous-isatuximab-in-combination-with-weekly-carfilzomib-and-dexamethasone-in-adult-participants-with-relapsed-andor-refractory-multiple-myeloma-100543492","NCT06356571","A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and\u002For Refractory Multiple Myeloma (RRMM)","SubQSA","Inclusion Criteria:\n\n* Participants must have a documented diagnosis of MM.\n* Participants with measurable disease defined as at least one of the following:\n\n  * Serum M-protein ≥0.5 g\u002FdL measured using serum protein immunoelectrophoresis and\u002For\n  * Urine M-protein ≥200 mg\u002F24 hours measured using urine protein immunoelectrophoresis and\u002For\n  * Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65).\n* Participants with relapsed and\u002For refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.\n* Contraceptive use by \\[men and women\\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  * Male participants agree to practice true abstinence or agree to use contraception while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.\n  * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP XE \" FCBP \" \\\\f Abbreviation \\\\t \"female of childbearing potential\" ) or agrees to practice complete abstinence or use contraception.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course.\n* Participants with prior anti-CD38 treatment if: a) administered \\\u003C 6 months before first isatuximab administration or, b) intolerant to the anti-CD38 previously received.\n* Participants who are refractory to carfilzomib.\n* Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents.\n* Participants with contraindication to dexamethasone and\u002For to carfilzomib.\n* Any anti-myeloma drug treatment within 14 days before the first isatuximab administration, including dexamethasone.\n* Prior allogenic HSC transplant with active graft versus host disease (GvHD XE \" GvHD \" \\\\f Abbreviation \\\\t \"graft versus host disease\" ) (GvHD any grade and\u002For being under immunosuppressive treatment within the last 2 months).\n* Any major procedure within 14 days before the first isatuximab administration: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy.\n* Vaccination with a live vaccine within 4 weeks before the first isatuximab administration. Seasonal flu vaccines that do not contain live virus are permitted.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":81,"type":20},64,[24],"The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.",[27],[86,87],"Anti CD38 monoclonal antibody","SARCLISA","2026-02-20",{"date":90,"type":40},"2026-02-23",{"date":92,"type":40},"2025-03-17",{"date":94,"type":20},"2027-07-15",{"name":46,"class":47},34]