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Comparing BMS-986393 with standard treatments for relapsed multiple myeloma

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

PHASE3 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06615479

This study is testing a new drug called BMS-986393 to see if it works better than standard treatments for adults with relapsed multiple myeloma who haven't responded to lenalidomide.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment440 (estimated)
Ages18 Years and up
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company (industry)
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT06615479 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of BMS-986393 compared to standard treatment regimens in adults with relapsed or refractory multiple myeloma who are also refractory to lenalidomide. Participants will receive either the investigational drug or standard therapies, including cyclophosphamide, fludarabine, daratumumab, and pomalidomide. The study will assess treatment outcomes and side effects to determine the potential advantages of BMS-986393 in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior treatment regimens and are refractory to lenalidomide.

Not a fit: Patients with active central nervous system involvement of multiple myeloma or those without measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promising results with CAR T-cell therapies in multiple myeloma, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, Chimeric Antigen Receptor T-cell, CAR T-cell Therapy, Arlocabtagene Autoleucel, Arlo-cel

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.