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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.