Overview

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

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Antibodies
Antibodies, Monoclonal
Bortezomib
Immunoglobulins
Melphalan
Prednisone
Siltuximab
Criteria
Inclusion Criteria:

- Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for
high dose chemotherapy with stem cell transplantation

- Eastern cooperative oncology group performance status score of less than or equal to 2

- Measurable secretory disease, defined as either serum monoclonal paraprotein greater
than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours

- Adequate laboratory results that will be confirmed by a study physician

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or
monoclonal gammopathy of undetermined significance

- Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is
present in the absence of a clonal plasma cell infiltration with lytic bone lesions

- Received prior or current systemic therapy or stem cell transplantation for multiple
myeloma

- Peripheral neuropathy or neuropathic pain (Grade 2 or higher)

- Received radiation therapy, plasmapheresis or surgery within 14 days

- Transplanted solid organ, with the exception of a corneal transplant

- Serious concurrent illness or history of uncontrolled heart disease