NCT07333261PHASE1Recruiting
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
Susan Bal
Start Date
2/9/2026
Completion Date
12/1/2041
Summary
This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.
Detailed Description
This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.
Eligibility Criteria
Age Range: 19 years to No maximum
Inclusion Criteria:
1. Age \> 18 years with no upper age limit
2. NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
3. Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.
4. ECOG performance status 0-1
5. Adequate organ function
Exclusion Criteria:
1. Known active or history of central nervous system (CNS) involvement of MM.
2. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.
3. Prior history of other malignancies
4. Uncontrolled infection
Other protocol-defined Inclusion/Exclusion criteria apply.
Interventions
DRUG
BMS-986453
Conditions
Multiple Myeloma
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States