Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986453 · 2 trials · 2 indications
Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.
| Arm | Type | Description |
|---|---|---|
| Single dose BMS-986453 | EXPERIMENTAL | 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. |
| Administration of BMS-986453 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986453 | DRUG | Will be given as a single dose administered by IV infusion. |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
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 crite...
Top 20 of 25 competitors
BMS-986453 is an investigational small molecule being developed for multiple myeloma, including relapsed and/or refractory multiple myeloma. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
BMS-986453 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug in patients with multiple myeloma.
BMS-986453 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy.
BMS-986453 is being studied in two Phase 1 trials. NCT06153251 is recruiting 187 participants with relapsed and/or refractory multiple myeloma in the United States, France, Germany, and Spain. NCT07333261 is recruiting 25 participants with newly diagnosed multiple myeloma in the United States.
BMS-986453 is a small molecule, but its specific molecular target has not been disclosed. The clinical trials for the drug are biomarker-selected, indicating that patient eligibility may be based on specific biological markers.