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

Completed · Phase 1

Conditions studied: Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Plasma Cell Neoplasm

In brief

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.

Key facts

Study ID

NCT01219010

Run by

Janssen Research & Development, LLC

People needed

30

Starts

2010-10-01

Expected to finish

2014-03-01

Last updated by the study team

2015-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MGUS (measurable serum M-protein < 3 g/dL AND clonal bone marrow plasma cells < 10% without any end organ damage), SMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% without any end organ damage) or IMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% and = 3 lytic bone lesions but no other end organ damage)
• Qualifying ECG results that will be checked by a central laboratory
• Negative urine drug screen for substances of abuse
• Qualifying hematology and chemistry laboratory results.

You may not qualify if…

• Diagnosis of symptomatic multiple myeloma
• Prior exposure to approved or investigational myeloma treatments
• Prior exposure to agents targeting IL-6 or the IL-6 receptor
• Significant cardiac disease
• Skin condition likely to interfere with ECG electrode placement, breast implant, or thoracic surgery
• Received medications known to affect the QT interval
• Vaccination with live, attenuated vaccines within 4 weeks
• Major surgery or radiation within 4 weeks

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Antwerp, Belgium
• Study site — Ghent, Belgium
• Study site — Izhevsk, Russia
• Study site — Moscow, Russia
• Study site — Nizhny Novgorod, Russia

Full record on ClinicalTrials.gov

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