drugset / Trial / NCT00911859

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients

NCT00911859

Phase 2 Completed 118 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).

Timeline

Start
2009-06
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Siltuximab Monoclonal antibody 8.3 mg/kg Intravenous
Subject Siltuximab Monoclonal antibody 11 mg/kg Intravenous
Comparator Bortezomib Small molecule 1.3 mg/m2 Intravenous
Comparator Melphalan Small molecule 9 mg/m2 Oral
Comparator Prednisone Other / unclassified 60 mg/m2 Oral

Indications