BMS-986453 for people with newly diagnosed multiple myeloma not pursuing a stem cell transplant
A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
This study tests whether BMS-986453 is safe and can keep newly diagnosed multiple myeloma under control for people who have finished initial therapy and are not having a stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07333261 on ClinicalTrials.gov |
What this trial studies
This open-label phase 1b trial enrolls adults with newly diagnosed multiple myeloma diagnosed within the past 12 months who have completed induction therapy and are not planning autologous stem cell transplant. Eligible participants must have ECOG performance status 0-1 and adequate organ function and will receive BMS-986453 as the investigational intervention. The study will monitor safety, tolerability, response rates, and duration of disease control over time to see if a one-time or limited course can prolong remission without continuous therapy. Outcomes include adverse events, disease response, and how long disease control is maintained.
Who should consider this trial
Good fit: Adults (over 18) with newly diagnosed multiple myeloma within the past 12 months who have completed induction therapy, are not eligible for or are deferring autologous stem cell transplant, have ECOG 0-1, and adequate organ function are the intended candidates.
Not a fit: Patients with CNS involvement of myeloma, plasma cell leukemia or other excluded plasma cell disorders, prior other malignancies, uncontrolled infection, or those planning stem cell transplant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, BMS-986453 could provide durable disease control with a limited treatment course and reduce the need for continuous therapy.
How similar studies have performed: Similar limited-course or maintenance-sparing approaches are being explored in multiple myeloma, but BMS-986453 is early-phase and has not yet demonstrated definitive success in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Susan Bal, MD — The University of Alabama at Birmingham
- Study coordinator: Susan Bal, MD
- Email: susanbal@uabmc.edu
- Phone: (205) 934-7645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.