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Back|NCT06615479Recruiting
Official Title

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

Phase
Phase 3
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrollment
440
Timeline
Mar 2025 → Jun 2032
About This Study

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 Criteria

Inclusion Criteria

  • 1Participants must have relapsed or refractory multiple myeloma (RRMM).
  • 2Participants 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.
  • 3Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
  • 4Participants must have measurable disease during screening.
  • 5Participants must have adequate organ function.
  • 6Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.

Exclusion Criteria

  • 1Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
  • 2Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
  • 3Participants must not need urgent treatment due to rapidly progressing MM.

Locations

134 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Nisha Joseph, Site 0058

502-608-5503

University of Alabama at Birmingham

Birmingham, Alabama 35205

Recruiting

Susan Bal, Site 0071

205-934-1908

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California 90404

Recruiting

Sarah Larson, Site 0032

310-829-5471
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →