Clinical trial Recruiting at 122 sites Phase 3 Interventional Ages 18 and up

Comparing BMS-986393 with standard treatments for relapsed multiple myeloma

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

Run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06615479 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment440 (estimated)
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Industry-sponsored
Locations141 sites (Birmingham, Alabama and 140 other locations)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedDecember 30, 2027
Study endsJune 22, 2032
Registry record updatedOctober 29, 2026
Trial IDNCT06615479 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

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 it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • UCLA Hematology/Oncology - Santa Monica
    Los Angeles, California, United States
    Recruiting
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center
    Orange, California, United States
    Recruiting
  • Georgetown University Medical Center
    Washington D.C., District of Columbia, United States
    Recruiting
  • Baptist MD Anderson Cancer Center
    Jacksonville, Florida, United States
    Recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting
Show 44 more locations
  • Winship Cancer Institute, Emory University
    Atlanta, Georgia, United States
    Recruiting
  • Louisiana State University Health Sciences Shreveport
    Shreveport, Louisiana, United States
    Recruiting
  • Boston Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Weill Cornell Medical College
    New York, New York, United States
    Recruiting
  • Levine Cancer Institute
    Charlotte, North Carolina, United States
    Recruiting
  • Levine Cancer Institute
    Charlotte, North Carolina, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • AHN West Penn Hospital
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • University of Texas MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • Huntsman Cancer Institute
    Salt Lake City, Utah, United States
    Recruiting
  • Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting
  • Hospital Italiano de Buenos Aires
    Abb, Buenos Aires F.D., Argentina
    Recruiting
  • Hospital Aleman
    Buenos Aires, Buenos Aires F.D., Argentina
    Recruiting
  • Ordensklinikum Linz GmbH Elisabethinen
    Linz, Upper Austria, Austria
    Recruiting
  • Hanusch-Krankenhaus
    Vienna, Austria
    Recruiting
  • Antwerp University Hospital
    Edegem, Antwerpen, Belgium
    Recruiting
  • Cliniques universitaires Saint-Luc
    Brussels, Bruxelles-Capitale, Région de, Belgium
    Recruiting
  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
    Yvoir, Namur, Belgium
    Recruiting
  • UZ Gent
    Ghent, Oost-Vlaanderen, Belgium
    Recruiting
  • A. C. Camargo Cancer Center
    São Paulo, São Paulo, Brazil
    Recruiting
  • Instituto D'Or de Pesquisa e Ensino (IDOR)
    São Paulo, Brazil
    Recruiting
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
    São Paulo, Brazil
    Recruiting
  • Arthur J.E. Child Comprehensive Cancer Centre
    Calgary, Alberta, Canada
    Recruiting
  • Vancouver General Hospital
    Vancouver, British Columbia, Canada
    Recruiting
  • QEII Health Sciences Centre - Victoria General Site
    Halifax, Nova Scotia, Canada
    Recruiting
  • Hamilton Health Sciences-Juravinski Cancer Centre
    Hamilton, Ontario, Canada
    Recruiting
  • CIUSSS de l'Est-de-l'Île-de-Montréal
    Montreal, Quebec, Canada
    Recruiting
  • Fakultní nemocnice Brno Bohunice
    Brno, Brno-město, Czechia
    Recruiting
  • Fakultni nemocnice Hradec Kralove
    Hradec Králové, Hradec Králové, Czechia
    Recruiting
  • Fakultni nemocnice Ostrava
    Ostrava, Moravian-Silesian Region, Czechia
    Recruiting
  • Vseobecna fakultni nemocnice v Praze
    Prague, Czechia
    Recruiting
  • Rigshospitalet
    Copenhagen, Capital Region, Denmark
    Recruiting
  • Aarhus Universitetshospital, Skejby
    Aarhus, Central Jutland, Denmark
    Recruiting
  • Roskilde Sygehus
    Køge, Region Sjælland, Denmark
    Recruiting
  • Odense Universitetshospital
    Odense, Region Syddanmark, Denmark
    Recruiting
  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
    Helsinki, Uusimaa, Finland
    Recruiting
  • Oulun yliopistollinen sairaala
    Oulu, Finland
    Recruiting
  • Turku University Hospital
    Turku, Finland
    Recruiting
  • Hopital Claude Huriez - CHU de Lille
    Lille, Nord, France
    Recruiting
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    Nantes, Pays de la Loire Region, France
    Recruiting
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, Rhône, France
    Recruiting
  • Henri Mondor Hospital
    Créteil, Val-de-Marne, France
    Recruiting
  • Hôpital Saint-Louis
    Paris, France
    Recruiting
  • TUM Klinikum
    Munich, Bavaria, Germany
    Recruiting

+91 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.