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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)
Interventions7
Locations22 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Susan Bal, Site 0071205-934-1908
UCLA Hematology/Oncology - Santa Monica
Sarah Larson, Site 0032310-829-5471
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Stefan Ciurea, Site 0050714-509-2290
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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