A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.

Key facts

Study ID

NCT00401843

Run by

Janssen Research & Development, LLC

People needed

307

Starts

2006-11-28

Expected to finish

2019-09-24

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable secretory disease defined as either serum monoclonal paraprotein, (M-protein) greater than or equal to (>=)1 gram per deciliter (g/dL) or urine monoclonal (light chain) protein (> 200 mg/24 hours)
• Documented disease progression after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
• ECOG performance status score of less than or equal to (<=) 2
• Adequate bone marrow, liver, and renal function

You may not qualify if…

• No prior treatment with bortezomib
• Not Refractory to high-dose dexamethasone
• Not >= Grade 2 peripheral neuropathy
• Have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
• No prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for <= 3 years

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — North Charleston, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Antwerp, Belgium
• Study site — B-8000 Brugge, Belgium
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium
• Study site — Leuven, Belgium
• Study site — Rio de Janeiro, Brazil
• Study site — Bulgaria, Bulgaria
• Study site — Pleven, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Vancouver, British Columbia, Canada
• Study site — Québec, Quebec, Canada
• Study site — Calgary, Canada
• Study site — Brno, Czechia
• Study site — Hradec Králové, Czechia
• Study site — Greenbrae, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.