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A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma


Description

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

Trial Eligibility

Inclusion Criteria * Participants must have relapsed or refractory multiple myeloma (RRMM). * 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 be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy). * Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria. * Participants must have measurable disease during screening. * Participants must have adequate organ function. * Participants must have an Eastern Cooperative Oncology group performance status 0 or 1. Exclusion Criteria * Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM). * Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease. * Participants must not need urgent treatment due to rapidly progressing MM. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study Info

Organization

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company


Primary Outcome

Progression Free Survival (PFS)


Outcome Timeframe Up to 5 years after the last participant is randomized

NCTID NCT06615479

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2025-02-15

Completion Date 2027-12-30

Enrollment Target 440

Interventions

DRUG BMS-986393

DRUG Cyclophosphamide

DRUG Fludarabine

DRUG Daratumumab

DRUG Pomalidomide

DRUG Dexamethasone

DRUG Carfilzomib

Locations Recruiting

Local Institution - 0071

United States, Alabama, Birmingham


UCLA Hematology/Oncology - Santa Monica

United States, California, Los Angeles


Local Institution - 0130

United States, Florida, Miami


Local Institution - 0058

United States, Georgia, Atlanta


Local Institution - 0133

United States, Maryland, Baltimore


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