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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-refractory Multiple Myeloma (QUINTESSENTIAL-2)

About

Brief Summary

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).
  • 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.

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Study Stats
Protocol No.
24-5367
Category
Multiple Myeloma
Contact
Danijela Covo
Location
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Westlake Village
  • UCLA Westwood
For Providers
NCT No.
NCT06615479
For detailed technical eligibility, visit ClinicalTrials.gov.