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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00461045 | Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma | PHASE2 | COMPLETED | 15 | — | — | Mar 1, 2007 | Oct 1, 2014 | Dec 19, 2017 | 6 | United States |
Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.
| Arm | Type | Description |
|---|---|---|
| MRZ 0.5 mg/m^2 | EXPERIMENTAL | Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles |
| Name | Type | Description |
|---|---|---|
| MRZ 0.5 mg/m^2 | DRUG | NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle |
Inclusion Criteria: Prior to Amendment 13: * Age 18 years. * Karnofsky Performance Status (KPS) score 70%. * All patients must have histologic evidence of multiple myeloma. Evidence of relapsed or relapsed/refractory disease for which no other approved treatment is available and clinically indicate...