Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Belamaf · 1 trial · 1 indication
The Recommended Phase 2 Dose (RP2D) will be determined based on the incidence of dose-limiting toxicities (DLTs), overall tolerability, and preliminary antitumor activity. DLTs will be evaluated based on adverse events, clinical assessments, and laboratory test results.
Overall Response Rate (ORR) is defined as the proportion of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG) criteria.
| Arm | Type | Description |
|---|---|---|
| Belamaf + Cevostamab | EXPERIMENTAL | Belamaf + Cevostamab will be administrated on the dose escalation schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are 42 days (Q6W). Up to 3 cohorts (Cohorts 1a-c) evaluating escalating doses of belamaf and cevostamab will be evaluated. (Cohort 1a - belamaf 1.9 mg/kg + cevostamab 90 mg; Cohort 1b - belamaf 1.9 mg/kg + cevostamab 160 mg; and Cohort 1c - belamaf 2.5 mg/kg + cevostamab 160 mg.) Treatment will continue until progression or unacceptable toxicity. Then, after the recommended phase 2 dose (RP2D) is determined, Cohort 2 will receive Belamaf + Cevostamab at the RP2D schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are 42 days (Q6W). Treatment will continue until progression or unacceptable toxicity. |
| Belamaf + Cevostamab+ Pomalidomide | EXPERIMENTAL | Belamaf + Cevostamab at RP2D with pomalidomide at 2 mg at 14/21 schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are are 42 days (Q6W). pomalidomide on 14/21 schedule. Treatment will continue until progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Belamaf | DRUG | Administered intravenously |
| Cevostamab | BIOLOGICAL | Administered intravenously |
| Pomalidomide | DRUG | Administered orally |
Inclusion Criteria: 1. Must be able to understand and voluntarily sign an informed consent form (ICF). 2. Must be ≥ 18 years of age at the time of signing the ICF. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Documented diagnosis of MM and must have: ...
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