Status:
RECRUITING
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions:
Relapsed and/or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06153251
Start Date
January 23 2024
End Date
May 2 2030
Last Update
June 19 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States, 94143
4
Stanford University Medical Center
Stanford, California, United States, 94305