drugset / Trial / NCT01219010

A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

NCT01219010

Phase 1 Completed 30 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.

Timeline

Start
2010-10
Primary completion
2012-06
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Siltuximab Monoclonal antibody 15 mg/kg Intravenous