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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |