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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Locations | 141 sites (Birmingham, Alabama and 140 other locations) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | June 22, 2032 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06615479 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
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
In Vivo PICX CAR-T Therapy for Relapsed or Refractory Multiple Myeloma
A single-arm study is testing an in vivo CAR-T cell therapy (PICX Injection) to see if it is safe and can help people with relapsed or refractory multiple myeloma.
-
F182112 versus standard care for relapsed or refractory multiple myeloma
This study will test whether F182112 works better than standard treatments for adults whose multiple myeloma has come back or stopped responding after prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
-
Dual-target BCMA and GPRC5D CAR-T for relapsed/refractory multiple myeloma with extramedullary disease
This will try a CAR-T cell treatment that targets both BCMA and GPRC5D for adults whose relapsed or refractory multiple myeloma has spread outside the bone marrow.
-
Dual-target BCMA–CD19 CAR-T therapy for relapsed or refractory multiple myeloma with extramedullary disease
This trial will try a CAR-T treatment that targets both BCMA and CD19 for adults whose relapsed or refractory multiple myeloma has spread outside the bone marrow.
-
Using patients' own modified immune cells to treat certain blood cancers
This study is testing a new treatment using modified immune cells to see if it can help people with certain blood cancers like multiple myeloma, leukemia, and lymphoma.
-
Combining Purinostat Mesylate with Pomalidomide and Dexamethasone for Multiple Myeloma
This study is testing if a new combination of medications can be safely used to help people with relapsed or hard-to-treat multiple myeloma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.