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

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).

Conditions

• Multiple Myeloma

Interventions

DRUG

Siltuximab11 mg/kg

Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1.

DRUG

Siltuximab 8.3 mg/kg or 11 mg/kg

Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period.

DRUG

Velcade (bortezomib)

Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1.

DRUG

Velcade (bortezomib)

Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period)

DRUG

Melphalan

Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.

DRUG

Melphalan

Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A.

DRUG

Prednisone

Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.

DRUG

Prednisone

Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A.

DRUG

Velcade (bortezomib)

Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert.

DRUG

Melphalan

Participants will take melphalan 9 mg/m2 orally according to currently approved package insert.

DRUG

Prednisone

Participants will take prednisone 60 mg/m2 orally according to the package insert.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development L.L.C Clinical Trial · Janssen Research & Development L.L.C

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• United States
• Australia
• France
• India
• Israel
• Poland
• Romania
• Russia
• Singapore
• South Korea
• Spain

Study Locations