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
Completed · Phase 2
Conditions studied: Multiple Myeloma
In brief
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).
Key facts
- Study ID
- NCT00911859
- Run by
- Janssen Research & Development, LLC
- People needed
- 118
- Starts
- 2009-06-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2014-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Boston, Massachusetts, United States
- Study site — Chapel Hill, North Carolina, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Houston, Texas, United States
- Study site — Adelaide, Australia
- Study site — Melbourne, Australia
- Study site — Bordeaux, France
- Study site — Montpellier, France
- Study site — Strasbourg, France
- Study site — Ahmedabad, India
- Study site — Calicut, India
- Study site — Hyderabad, India
- Study site — Jaipur, India
- Study site — Mumbai, India
- Study site — Afula, Israel
- Study site — Haifa, Israel
- Study site — Jerusalem, Israel
- Study site — Petah Tikva, Israel
- Study site — Ramat Gan, Israel
- Study site — Bialystok, Poland
- Study site — Chorzów, Poland
- Study site — Gdynia, Poland
- Study site — Lodz, Poland
- Study site — Wroclaw, Poland
- Study site — Baia Mare, Romania
Full record on ClinicalTrials.gov
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