drugset / Trial / NCT00561743

A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients

NCT00561743 ↗

Phase 2 Completed 50 enrolled Janssen-Ortho Inc., Canada
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether doxorubicin HCL liposome injection, bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of action.

Timeline

Start
2005-11
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Dexamethasone Small molecule 40 mg Oral
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous

Indications