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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)

RECRUITINGPhase 3Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Actively Recruiting
PhasePhase 3
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Started2025-03-12
Est. completion2027-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations22 sites
View on ClinicalTrials.gov →

NCT06615479

Summary

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerRelapsed or Refractory Multiple Myeloma (RRMM)

Locations22 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35205
Susan Bal, Site 0071205-934-1908
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
Sarah Larson, Site 0032310-829-5471
Local Institution - 0050
Orange, California, 92868
Site 0050
Local Institution - 0223
Washington D.C., District of Columbia, 20007
Site 0223
Local Institution - 0231
Jacksonville, Florida, 32207
Site 0231

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