Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Belantamab mafodotin · 1 trial · 2 indications
No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).
Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: No Prior CAR T-Cell Therapy | EXPERIMENTAL | This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. |
| Cohort 2: Prior CAR T-Cell Therapy | EXPERIMENTAL | This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. |
| Name | Type | Description |
|---|---|---|
| Belantamab mafodotin | DRUG | Cycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles) |
| Carfilzomib | DRUG | Cycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15 Cycles 2-8: 56 mg/m2 on Days 1/8/15 Cycles 9+: 56 mg/m2 on Days 1/15 |
| Pomalidomide | DRUG | 3 mg Day 1-21 of 28-day Cycle |
| Dexamethasone | DRUG | Cycles 1-4: 40 mg Days 1/8/15/22 Cycles 5+: 20 mg Days 1/8/15/22 |
1. Subject must be ≥ 18 years of age. 2. Life expectancy of more than three months. 3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 4. Subject must have adequate organ function, defined by clinically confirmed lab values set by the study team. 5. Female Su...
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Belantamab mafodotin is an investigational drug being studied for the treatment of multiple myeloma, specifically in patients with relapsed multiple myeloma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Belantamab mafodotin is an antibody-drug conjugate that targets B-cell maturation antigen (BCMA), a protein expressed on multiple myeloma cells. By binding to BCMA, it delivers a cytotoxic agent to the cancer cells, leading to their destruction.
Belantamab mafodotin is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple myeloma.
Belantamab mafodotin is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness for treating multiple myeloma.
Belantamab mafodotin is being evaluated in a Phase 2 clinical trial with the identifier NCT05789303. This study is investigating the drug in combination with carfilzomib, pomalidomide, and dexamethasone in patients with relapsed multiple myeloma. The trial is currently recruiting participants in the United States.