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)

Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 440

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

Location: University of Alabama at Birmingham Birmingham Alabama

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06615479). StuddyBuddy aggregates publicly available trial information.