CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Siltuximab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01484275
NCT01484275Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma

Janssen Research & Development, LLC·interventional·Posted Dec 2, 2011·Updated Jan 27, 2020

In Brief

A Phase 2 clinical trial evaluating Siltuximab and Placebo for High-risk Smoldering Multiple Myeloma. Completed, enrolled 85 participants across 40 sites in 11 countries.

Detailed 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 smoldering multiple myeloma (SMM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh-risk Smoldering Multiple Myeloma
CountriesAustralia, Belgium, France, Germany, Greece, Israel, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2011
Enrollment StartMar 1, 2012
Primary CompletionMay 12, 2015
Study CompletionAug 21, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.6 years ago

Interventions

Siltuximabdrug

Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.

Placebodrug

Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.