Nctid:
NCT06232707
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27", "removedCountries"=>["Netherlands"]}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009101", "term"=>"Multiple Myeloma"}, {"id"=>"D054219", "term"=>"Neoplasms, Plasma Cell"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D020141", "term"=>"Hemostatic Disorders"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D010265", "term"=>"Paraproteinemias"}, {"id"=>"D001796", "term"=>"Blood Protein Disorders"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D006474", "term"=>"Hemorrhagic Disorders"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M12058", "name"=>"Multiple Myeloma", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}, {"id"=>"M27588", "name"=>"Neoplasms, Plasma Cell", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M21977", "name"=>"Hemostatic Disorders", "relevance"=>"LOW"}, {"id"=>"M5059", "name"=>"Blood Coagulation Disorders", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M13178", "name"=>"Paraproteinemias", "relevance"=>"LOW"}, {"id"=>"M5077", "name"=>"Blood Protein Disorders", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M9560", "name"=>"Hemorrhagic Disorders", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T3947", "name"=>"Multiple Myeloma", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003907", "term"=>"Dexamethasone"}, {"id"=>"C556306", "term"=>"Daratumumab"}, {"id"=>"C467566", "term"=>"Pomalidomide"}, {"id"=>"C546027", "term"=>"Elotuzumab"}, {"id"=>"D000911", "term"=>"Antibodies, Monoclonal"}], "ancestors"=>[{"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D006133", "term"=>"Growth Substances"}, {"id"=>"D006131", "term"=>"Growth Inhibitors"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M233261", "name"=>"Pomalidomide", "asFound"=>"SBRT", "relevance"=>"HIGH"}, {"id"=>"M272211", "name"=>"Daratumumab", "asFound"=>"Weaning", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M272319", "name"=>"Elotuzumab", "asFound"=>"Pancreaticoduodenectomy", "relevance"=>"HIGH"}, {"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M4230", "name"=>"Antibodies, Monoclonal", "asFound"=>"Weaning", "relevance"=>"HIGH"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"whyStopped"=>"Business objectives have changed", "overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"2024-05-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2030-09-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-30", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-11-16", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Progression-free Survival (PFS)", "timeFrame"=>"Up to 5 years"}], "secondaryOutcomes"=>[{"measure"=>"Overall Survival (OS)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Overall response (OR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Complete response (CR) or better", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Very good partial response (VGPR) or better", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to response (TTR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Duration of response (DOR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to progression (TTP)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to next treatment (TTNT)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Progression-free survival 2 (PFS2)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Restricted mean DOR (RMDOR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Minimal residual disease (MRD) negativity rate", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Incidence of adverse events (AEs)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Incidence of serious adverse events (SAEs)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)", "timeFrame"=>"Up to 5 years"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Relapsed or Refractory Multiple Myeloma", "BMS-986349", "CC-93269", "RRMM", "Alnuctamab", "CA058-1019", "ALUMMINATE RRMM"], "conditions"=>["Multiple Myeloma"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html", "label"=>"BMS Clinical Trial Information"}, {"url"=>"https://www.bmsstudyconnect.com/s/US/English/USenHome", "label"=>"BMS Clinical Trial Patient Recruiting"}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.\n* Documented diagnosis of multiple myeloma (MM), and must:.\n\n i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.\n\nii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).\n\niii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.\n\niv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.\n\n* Must have measurable disease (as determined by central laboratory).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.\n\nExclusion Criteria\n\n* Active, uncontrolled, or suspected infection.\n* Known current, or history of, central nervous system involvement of multiple myeloma.\n* History or presence of clinically relevant CNS pathology.\n* Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.\n* Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, "identificationModule"=>{"nctId"=>"NCT06232707", "acronym"=>"ALUMMINATE", "briefTitle"=>"A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Celgene"}, "officialTitle"=>"A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM", "orgStudyIdInfo"=>{"id"=>"CA058-1019"}, "secondaryIdInfos"=>[{"id"=>"2023-509472-42", "type"=>"REGISTRY", "domain"=>"EU Trial Number"}, {"id"=>"U1111-1281-8227", "type"=>"REGISTRY", "domain"=>"WHO"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm A: Alnuctamab", "interventionNames"=>["Drug: Alnuctamab"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Arm B: Standard of Care Regimens", "interventionNames"=>["Drug: Pomalidomide", "Drug: Daratumumab", "Drug: Elotuzumab", "Drug: Carfilzomib", "Drug: Dexamethasone"]}], "interventions"=>[{"name"=>"Alnuctamab", "type"=>"DRUG", "otherNames"=>["BMS-986349", "CC-93269"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm A: Alnuctamab"]}, {"name"=>"Pomalidomide", "type"=>"DRUG", "otherNames"=>["POMALYST®", "IMNOVID®", "CC-4047", "BMS-986379"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Daratumumab", "type"=>"DRUG", "otherNames"=>["DARZALEX®", "DARZALEX", "FASPRO®"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Elotuzumab", "type"=>"DRUG", "otherNames"=>["Empliciti®", "BMS-901608"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care 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