drugset / Trial / NCT00401843

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

NCT00401843

Phase 2 Completed 307 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.

Timeline

Start
2006-11-28
Primary completion
2011-08-16
Completion
2019-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Siltuximab Monoclonal antibody 6 mg/kg Intravenous
Background Bortezomib Small molecule 1.3 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg

Indications