Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. FDA label
Belantamab Mafodotin-Blmf · 1 trial · 8 indications
The number (%) of participants with DLTs using the DLT evaluable population.
The number (%) of participants with AEs and SAEs using the DLT evaluable and Safety populations
The number (%) of participants with grade 2 or above KVA events
ORR as per International Myeloma Working Group (IMWG) by Investigator Assessment; defined as the percentage of participants with a confirmed Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) or stringent Complete Response sCR in the intent-to-treat (ITT) set.
| Arm | Type | Description |
|---|---|---|
| Part 1 : Dose finding | EXPERIMENTAL | Belantamab mafodotin will be administered as a combination therapy as a calculated dose on Day 1 of every other 28-day cycle. Belantamab mafodotin starting dose: • 1.4 mg/kg Q8W (i.e., on Day 1 of every other 28-day cycle) * Dose Level +1: 1.9 mg/kg Q8W * Dose Level -1: 1.0 mg/kg Q8W * Dose Level -2: 1.0 mg/kg Q12W Lenalidomide: 25 mg/d on day 1-21 of every 28-day cycle. Dexamethasone: 40 mg/d on days 1, 8, 15, 22 of every 28-day cycle in participants \< 75 years; 20 mg/d on days 1, 8, 15, 22 of every 28-day cycle in participants ≥ 75 years Nirogacestat: 100 mg twice a day (BID) starting on day -3 and then each day of every other 28-day cycle (i.e., to be given only on cycles where belantamab mafodotin is administered). |
| Name | Type | Description |
|---|---|---|
| Belantamab Mafodotin-Blmf | DRUG | Blmf will be available as 100 mg/vial in single-use vial for reconstitution, supplied as lyophilized powder. Blmf will be delivered as IV solution over at least 30 minutes. |
| Lenalidomide | DRUG | Lenalidomide will be administered per os. |
| Dexamethasone | DRUG | Dexamethasone will be administered intravenously or per os. |
| Nirogacestat | DRUG | Nirogacestat will be administrated each day for all subsequent cycles were Blmf is also administrated. |
Inclusion Criteria: 1. Participant must be \>18 years of age 2. Monoclonal plasma cells in the bone marrow (BM) ≥10% or presence of a biopsy proven plasmacytoma and documented Multiple Myeloma (MM) satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignan...
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