NCT02072863

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

Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Oprozomib	Study subjects will receive oprozomib administered orally.
DRUG	Melphalan	Study subjects will receive melphalan 9 mg/m2.
DRUG	Prednisone	Study subjects will receive prednisone 60 mg/m2.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2015-09-01
• First posted: 2014-02-27
• Last updated: 2017-05-02

Locations

8 sites across 3 countries: Greece, Italy, Netherlands