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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)

NCT06615479

RecruitingPhase 3

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions: BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (141)

Birmingham, Alabama, United States
Los Angeles, California, United States
Orange, California, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States
ABB, Buenos Aires F.D., Argentina
ABB, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Camperdown, New South Wales, Australia
Liverpool, New South Wales, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Clayton, Victoria, Australia
+ 111 more on CT.gov