drugset / Trial / NCT00872521

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma

NCT00872521 ↗

Phase 2 Completed 107 enrolled Janssen-Cilag Pty Ltd
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma.

Timeline

Start
2009-01
Primary completion
2011-03
Completion
2011-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 1q21 Not Amplified vs 1q21 Amplified; p = 0.09; Chi-squared NCT00872521 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous

Indications