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Not Yet Recruiting

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) - CA088-1007

Updated: 31 October, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 53

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Drug: BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib
Active Comparator: Arm B
Drug: Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib

Key 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 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.

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001