A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of adverse events (AEs)
Time frame: Up to 2 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 2 years
Incidence of adverse events of special interest (AESI)
Time frame: Up to 2 years
Incidence of AEs leading to discontinuation
Time frame: Up to 2 years
Secondary Endpoints
Overall response rate (ORR)
Complete response rate (CRR)
Very good partial response rate (VGPRR)
Eligibility Criteria
Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies. * Other protocol-defined inclusion/exclusion criteria apply.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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