A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
Susan Bal
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.
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
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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 am…
Interventions
- DrugBMS-986453
Will be given as a single dose administered by IV infusion.
Location
- University of Alabama at BirminghamBirmingham, Alabama