drugset / Trial / NCT02072863

A Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma

NCT02072863

Phase 1/2 Completed 9 enrolled Amgen
NaSingle-groupOpen-labelTreatment

Summary

The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of oprozomib in combination with melphalan and prednisone (OMP). The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and complete response rate (CRR) of the OMP combination.

Timeline

Start
2014-01
Primary completion
2015-01
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Oprozomib Small molecule Oral
Background Melphalan Small molecule 9 mg/m2
Background Prednisone Other / unclassified 60 mg/m2

Indications