A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Purpose

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Condition

  • Relapsed and/or Refractory Multiple Myeloma

Eligibility

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

Inclusion Criteria

  • Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease. - Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry. - Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Participants must have adequate organ function.

Exclusion Criteria

  • Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma. - Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis. - Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis. - Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of BMS-986453
  • Drug: BMS-986453
    Specified dose on specified days
  • Drug: Fludarabine
    Specified dose on specified days
    Other names:
    • FludAra
    • Oforta
  • Drug: Cyclophosphamide
    Specified dose on specified days
    Other names:
    • Cytoxan
    • Cytoxan Lyophilized
    • Neosar

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Luciano Costa, Site 0001
205-934-9695

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