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
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.
Arms & 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
Outcome measures
Primary
Progression Free Survival (PFS)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Time frame: Up to 1 year after the last participant is randomized
Secondary
Overall survival (OS)
Time frame: Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Time frame: Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Time frame: Up to 5 years after the last participant is randomized
Time to response (TTR)
Time frame: Up to 5 years after the last participant is randomized
Duration of response (DOR)
Time frame: Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
Time frame: Up to 5 years after the last participant is randomized
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
Time frame: Up to 5 years after the last participant is randomized
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Time frame: Up to 5 years after the last participant is randomized
Eligibility criteria
Study locations (22)
University of Alabama at Birmingham
Birmingham, Alabama, 35205
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Local Institution - 0223
Washington D.C., District of Columbia, 20007
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Local Institution - 0228
Orlando, Florida, 32803
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103
Boston Medical Center
Boston, Massachusetts, 02118
Local Institution - 0219
Minneapolis, Minnesota, 55455
Weill Cornell Medical College
New York, New York, 10065
Local Institution - 0221
Stony Brook, New York, 11794
Levine Cancer Institute
Charlotte, North Carolina, 28204
Levine Cancer Institute
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Local Institution - 0232
Pittsburgh, Pennsylvania, 15224
Local Institution - 0227
Charleston, South Carolina, 29425
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226