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0206","07977969791",{"type":1942,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[1944],{"name":1945,"class":6},"Celgene Corporation","100563385","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986393-versus-standard-regimens-in-adult-participants-with-relapsed-or-refractory-and-lenalidomide-exposed-multiple-myeloma-quintessential-2-100563385",false,"NCT06615479","A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)","A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma","Inclusion Criteria\n\n* Participants must have relapsed or refractory multiple myeloma (RRMM).\n* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.\n* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.\n* Participants must have measurable disease during screening.\n* Participants must have adequate organ function.\n* Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.\n\nExclusion Criteria\n\n* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).\n* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.\n* Participants must not need urgent treatment due to rapidly progressing MM.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":1956,"type":1957},440,"ESTIMATED","INTERVENTIONAL",[1960],"PHASE3","The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.",[1963],"Relapsed or Refractory Multiple Myeloma (RRMM)",[1965,1966,27,1967,1968,1969,31],"Relapsed or Refractory Multiple Myeloma","Multiple Myeloma","Chimeric Antigen Receptor T-cell (CAR T-cell)","CAR T-cell Therapy","Arlocabtagene Autoleucel","2026-06-25",{"date":1972,"type":1973},"2026-06-26","ACTUAL",{"date":1975,"type":1973},"2025-03-12",{"date":1977,"type":1957},"2032-06-22",{"name":5,"class":6},140]