Phase 3 Study Comparing Arlocabtagene Autoleucel BMS-986393 CAR-T Therapy to Standard Treatments in Adults with Relapsed or Refractory Multiple Myeloma Previously Treated with Lenalidomide

What this Trial Is About

Researchers are evaluating the efficacy and safety of arlo-cel BMS-986393, a GPRC5D-directed CAR-T cell therapy, compared to standard treatment regimens in adults with relapsed or refractory multiple myeloma who have been exposed to lenalidomide. This Phase 3 study aims to better understand how this new therapy performs in this patient group and may provide important insights into treatment options for this condition. Participants will be randomly assigned to receive either the investigational CAR-T cell therapy arlo-cel or one of the standard treatment regimens, which may include drugs such as Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, or Carfilzomib. The investigational therapy involves specified doses given on specific days. The study is open-label, multicenter, and will follow participants over time to assess outcomes. During the study, participants will be monitored for progression-free survival and minimal residual disease negativity for up to five years after the last participant is enrolled. Additional outcomes include overall survival, response rates, quality of life changes, and drug concentration levels. Researchers will conduct regular assessments including clinical evaluations and laboratory tests to gather these data. The total participation may last several years to fully capture long-term effects and safety.

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)