Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

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

NCT ID: NCT06615479Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2026-06-04

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

Sex: AllAge: 18 Years and olderHealthy 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 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 locations (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35205

Recruiting
Susan Bal, Site 0071 · Contact

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, 90404

Recruiting
Sarah Larson, Site 0032 · Contact

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, California, 92868

Recruiting
Stefan Ciurea, Site 0050 · Contact

Local Institution - 0223

Washington D.C., District of Columbia, 20007

Not Yet Recruiting
Site 0223 · Contact

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

Recruiting
Maxim Norkin, Site 0231 · Contact

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136

Recruiting
Damian Green, Site 0130 · Contact

Local Institution - 0228

Orlando, Florida, 32803

Not Yet Recruiting
Site 0228 · Contact

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

Recruiting
Nisha Joseph, Site 0058 · Contact

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71103

Recruiting
Shashank Cingam, Site 0218 · Contact

Boston Medical Center

Boston, Massachusetts, 02118

Recruiting
Raphael Szalat, Site 0196 · Contact

Local Institution - 0219

Minneapolis, Minnesota, 55455

Not Yet Recruiting
Site 0219 · Contact

Weill Cornell Medical College

New York, New York, 10065

Recruiting
Mateo Mejia Saldarriaga, Site 0229 · Contact

Local Institution - 0221

Stony Brook, New York, 11794

Not Yet Recruiting
Site 0221 · Contact

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting
Barry Paul, Site 0216 · Contact

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting
Barry Paul, Site 0067 · Contact

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Sandra Mazzoni, Site 0193 · Contact

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting
Asya Varshavsky-Yanovsky, Site 0097 · Contact

Local Institution - 0232

Pittsburgh, Pennsylvania, 15224

Not Yet Recruiting
Site 0232 · Contact

Local Institution - 0227

Charleston, South Carolina, 29425

Not Yet Recruiting
Site 0227 · Contact

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Oren Pasvolsky, Site 0184 · Contact

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Recruiting
Brian McClune, Site 0044 · Contact

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Othman Akhtar, Site 0195 · Contact