A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
Recruiting now · Phase 3
Conditions studied: Relapsed or Refractory Multiple Myeloma (RRMM)
In brief
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.
Key facts
- Study ID
- NCT06615479
- Run by
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- People needed
- 440
- Starts
- 2025-03-12
- Expected to finish
- 2032-06-22
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange, California, United States (enrolling)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
- Boston Medical Center — Boston, Massachusetts, United States (enrolling)
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
- University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida, United States (enrolling)
- Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
- Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- Louisiana State University Health Sciences Shreveport — Shreveport, Louisiana, United States (enrolling)
- UCLA Hematology/Oncology - Santa Monica — Los Angeles, California, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
- Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina (enrolling)
- Weill Cornell Medical College — New York, New York, United States (enrolling)
- Hospital Aleman — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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