Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 part...
Detailed Description
The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to as siltuximab) for a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00911859
Start Date
June 1 2009
End Date
April 1 2013
Last Update
November 18 2014
Active Locations (37)
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1
Boston, Massachusetts, United States
2
Chapel Hill, North Carolina, United States
3
Philadelphia, Pennsylvania, United States
4
Houston, Texas, United States