A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
Summary
The purpose of the Phase 1 part of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of oprozomib in combination with pomalidomide and dexamethasone in adults with primary refractory or relapsed and refractory multiple myeloma. The purpose of the Phase 3 part of the study is to compare the efficacy for adults with primary refractory or relapsed and refractory multiple myeloma who are randomized to either oprozomib or placebo in combination with pomalidomide and dexamethasone.
Timeline
- Start
- 2014-07-30
- Primary completion
- 2019-04-25
- Completion
- 2019-04-25
Outcome
Outcome not reported
Stopped (Enrollment): “A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in OPZ007 was halted during dose-expansion.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Oprozomib | Small molecule | 150 mg | Oral |
| Subject | Oprozomib | Small molecule | 210 mg | Oral |
| Subject | Oprozomib | Small molecule | 240 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 2 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |