The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
Participants must have measurable disease during screening.
Active or history of central nervous system involvement with MM.
Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
Other protocol-defined Inclusion/Exclusion criteria apply.
Single group
Arlocabtagene Autoleucel
Biological/VaccineSpecified dose on specified days
Cohort 1: Best overall response (BOR) of partial response (PR) or better
The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)
BOR of partial response (PR) or better
The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
The number and percent of participants achieving complete response (CR) \[including stringent complete response sCR\] in participants having received at least 3 prior lines of therapy (LOT)
Minimal residual disease (MRD) negative status
Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)
Click on the lead sponsor to view all of their trials.
