Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma
Summary
The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Phase 2: * To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR) * To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes
Timeline
- Start
- 2013-10-28
- Primary completion
- 2019-09-23
- Completion
- 2019-09-23
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 OPZ003 was halted during dose-escalation.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Oprozomib | Small molecule | 150 mg | Oral |
| Subject | Oprozomib | Small molecule | 180 mg | Oral |
| Subject | Oprozomib | Small molecule | 210 mg | Oral |
| Subject | Oprozomib | Small molecule | 240 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |