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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03605719 | Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma | PHASE1 | COMPLETED | 23 | — | — | Oct 24, 2018 | Oct 10, 2022 | Oct 6, 2023 | 2 | United States |
A DLT is defined as one of the following toxicities: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/µL) lasting 5 days or more. * Grade 3 to 4 thrombocytopenia associated with bleeding requiring platelet transfusion * Cardiac dysfunction: Grade \> 3 left ventricular systolic dysfunction or grade \> 2 myocarditis * Any grade 3-4 treatment-emergent non-hematologic adverse event (AE) clearly unrelated to the underlying disease and considered to be at least possibly related to protocol therapy
The Escalation with Overdose Control (EWOC) design will be used to identify the MTD.
A DLT is defined as one of the following toxicities: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/µL) lasting 5 days or more. * Grade 3 to 4 thrombocytopenia associated with bleeding requiring platelet transfusion * Cardiac dysfunction: Grade \> 3 left ventricular systolic dysfunction or grade \> 2 myocarditis * Any grade 3-4 treatment-emergent non-hematologic adverse event (AE) clearly unrelated to the underlying disease and considered to be at least possibly related to protocol therapy
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm 2 | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm 3 (expansion) | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib | DRUG | Given IV |
| Dexamethasone | DRUG | Given IV |
| Nivolumab | BIOLOGICAL | Given IV |
| Pelareorep | BIOLOGICAL | Given IV |
Inclusion Criteria: * Patient must have multiple myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria * In arm 3 but not for arms 1 or 2, patients must have measurable disease defined as any of the following: * Serum monoclonal protein ≥ 0.5 g/dL by protein...