Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a research study with an experimental drug called siltuximab (also known as CNTO 328). Currently there are studies with siltuximab, completed or ongoing, in patients with blood cancers such as...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01219010
Start Date
October 1 2010
End Date
March 1 2014
Last Update
January 19 2015
Active Locations (8)
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1
Chicago, Illinois, United States
2
Dallas, Texas, United States
3
Houston, Texas, United States
4
Antwerp, Belgium