Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
Purpose
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.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 19 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a single center, open-label, Phase 1b study to determine the safety, and preliminary efficacy of BMS-986453, a dual targeting CAR-T cell product targeting BCMA and GPRC5D, in participants with NDMM in whom ASCT is not planned. The study will evaluate the safety, PK, pharmacodynamic, and preliminary efficacy of BMS-986453 at the RP2D. All treated participants will complete three periods: pre-treatment, treatment, and post- treatment follow-up.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single dose BMS-986453 |
Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion. A single dose of BMS-986453 administered by IV infusion. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
More Details
- Status
- Recruiting
- Sponsor
- Susan Bal
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.