Prospective Observation of Cardiac Safety With Proteasome Inhibition
Completed
Conditions studied: Heart Failure, Multiple Myeloma
In brief
The purpose of this study is to better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events.
Key facts
- Study ID
- NCT02178579
- Run by
- Vanderbilt University Medical Center
- People needed
- 95
- Starts
- 2014-11-01
- Expected to finish
- 2019-07-15
- Last updated by the study team
- 2020-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
- Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
- Males and females ≥ 18 years of age
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
You may not qualify if…
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis
- Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
- Waldenström Macroglobulinemia
- Myelodysplastic syndrome
- History of MI within the last 3 months
- Symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
- Class 3 or 4 New York Heart Association Heart Failure in the past 3 months
- Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Where it is running
- University of Pennsylvania/Smilow Center for Translational Research — Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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