Overview

Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma

Status:
Terminated

Trial end date:
2019-09-23

Target enrollment:

Participant gender:

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

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Amgen
Onyx Therapeutics, Inc.

Treatments:

BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide