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
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 have prior exposure to lenalidomide. * 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 a…
Interventions
- DrugBMS-986393
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugDaratumumab
Specified dose on specified days
- DrugPomalidomide
Specified dose on specified days
- DrugDexamethasone
Specified dose on specified days
- DrugCarfilzomib
Specified dose on specified days
Locations (138)
- University of Alabama at BirminghamBirmingham, Alabama
- UCLA Hematology/Oncology - Santa MonicaLos Angeles, California
- Local Institution - 0050Orange, California
- Local Institution - 0223Washington D.C., District of Columbia
- Baptist MD Anderson Cancer CenterJacksonville, Florida
- University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, Florida