Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05581875 | A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory | PHASE1 | NOT YET_RECRUITING | 48 | — | — | Oct 20, 2022 | Oct 31, 2026 | Oct 17, 2022 | - | — |
The number (percent) of participants with DLTs using the DLT evaluable population.
The number (percent) of participants with AEs and SAEs using the DLT evaluable and Safety populations.
The number (percent) of participants with Grade ≥2 ocular toxicity per Keratopathy Visual Acuity (KVA) scale.
ORR as per 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 CR (sCR) (For the 'intention to treat' (ITT) population).
| Arm | Type | Description |
|---|---|---|
| Part 1 : Dose finding | EXPERIMENTAL | Belantamab mafodotin will be administered by intravenous infusion as a combination therapy as a calculated dose on Day 1 of every other 28-day cycle. Belantamab mafodotin starting dose for Part 1: * Cohort 1: 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle * Cohort 2: 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle Daratumumab 1800mg SC (fixed dose) on: Cycles 1-2: days 1, 8, 15, 22 Cycles 3-6: days 1, 15 Cycles 7+: day 1 Pomalidomide: 4 mg/d on days 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. |
| 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 |
| Daratumumab | DRUG | Daratumumab will be administered with subcutaneous injections. On days where Blmf is given together with daratumumab, daratumumab should be performed first. |
| Pomalidomide | DRUG | Pomalidomide will be administered per os. |
| Dexamethasone | DRUG | Dexamethasone will be administered intravenously or per os. |
Inclusion Criteria: 1. Participant must be ≥18 years or older. 2. Documented diagnosis of Multiple Myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. 3. Must have at least ONE aspect of measurable disease, defined as one of the following: 1. Urine M-protein excretion ≥200 ...