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)

Purpose

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.

Condition

  • Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • Arlo-cel
  • Drug: Cyclophosphamide
    Specified dose on specified days
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Daratumumab
    Specified dose on specified days
  • Drug: Pomalidomide
    Specified dose on specified days
  • Drug: Dexamethasone
    Specified dose on specified days
  • Drug: Carfilzomib
    Specified dose on specified days
Active Comparator
Arm B
  • Drug: Daratumumab
    Specified dose on specified days
  • Drug: Pomalidomide
    Specified dose on specified days
  • Drug: Dexamethasone
    Specified dose on specified days
  • Drug: Carfilzomib
    Specified dose on specified days

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35205
Contact:
Susan Bal, Site 0071
205-934-1908

More Details

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

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com