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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02514382 | Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 14 | — | — | Aug 21, 2015 | Apr 19, 2022 | Aug 14, 2023 | 1 | United States |
The safety of the bortezomib, dexamethasone, and wild-type reovirus combination will be assessed by the evaluation of the type, frequency, and severity of adverse events.
| Arm | Type | Description |
|---|---|---|
| Treatment (dexamethasone, bortezomib, wild-type reovirus) | EXPERIMENTAL | Patients receive dexamethasone PO, IV, or IM and bortezomib SC (preferably) or IV over 3-5 seconds on days 1, 8, and 15. Patients also receive wild-type reovirus IV over 60 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Bortezomib | DRUG | Given SC or IV |
| Dexamethasone | DRUG | Given PO, IV, or IM |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pharmacological Study | OTHER | Correlative studies |
| Wild-type Reovirus | BIOLOGICAL | Given IV |
Inclusion Criteria: * Have relapsed or refractory MM after at least one line of therapy * Have a confirmed diagnosis of MM with measurable disease, as defined by the presence of monoclonal immunoglobulin protein in serum electrophoreses of at least 0.5 g/dL for immunoglobulin G (IgG) or 0.25 g/dL f...