Siltuximab in Patients with High-risk Smoldering Multiple Myeloma
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects with High-risk Smoldering Multiple Myeloma
IRAS ID
87960
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2011-001735-22
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high risk smouldering multiple myeloma (SMM).
Siltuximab is and anti IL-6 antibody and this study is designed to investigate whether blocking IL-6 cell signalling with Siltuximab could delay the transition from a high risk premalignant condition (SMM) to symptomatic multiple myeloma.
This is a randomized (treatment assigned by chance), double blind (neither patient nor investigator know which treatment is given), multicenter study to evaluate the safety and efficacy of siltuximab compared with placebo in patients with high risk SMM. Approximately 100 patients will receive either siltuximab or placebo by intravenous (IV, injection into a vein) infusion every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study (approximately 4 years after randomization of the last patient). Patient safety will be monitored. Patients will receive either 15 mg/kg of siltuximab or placebo given as a 1hour IV infusion, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study(approximately 4 years after randomization of the last patient).REC name
London - Brent Research Ethics Committee
REC reference
11/LO/1853
Date of REC Opinion
29 Nov 2011
REC opinion
Favourable Opinion