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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...
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BMS-986453 is an investigational small molecule being studied for the treatment of multiple myeloma, including newly diagnosed disease and relapsed and/or refractory multiple myeloma. It is in Phase 1 clinical development and has not been approved for any indication. Bristol-Myers Squibb is evaluating it in oncology settings where patients have multiple myeloma.
BMS-986453 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor of the Phase 1 clinical trials evaluating the drug in multiple myeloma, including newly diagnosed and relapsed and/or refractory disease.
BMS-986453 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. Bristol-Myers Squibb is running Phase 1 studies in multiple myeloma, with one trial in newly diagnosed disease and one in relapsed and/or refractory multiple myeloma.
BMS-986453 is being studied in two Phase 1 trials. NCT07333261 is a recruiting study in newly diagnosed multiple myeloma with an enrollment of 25 in the United States. NCT06153251 is a recruiting study in relapsed and/or refractory multiple myeloma with an enrollment of 187 across the United States, France, Germany, and Spain.
BMS-986453 is an investigational Phase 1 small molecule being evaluated for relapsed and/or refractory multiple myeloma. The trial NCT06153251 is a recruiting Phase 1 study in that patient population, enrolling 187 participants across the United States, France, Germany, and Spain. It has not been approved for this or any indication.
BMS-986453 is not approved by the FDA. It is an investigational small molecule in Phase 1 clinical development for multiple myeloma, including newly diagnosed and relapsed and/or refractory disease. Bristol-Myers Squibb is currently recruiting participants into its Phase 1 trials of the drug.