Prospective Observation of Cardiac Safety With Proteasome Inhibition

Study Overview
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Brief Summary
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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.

Detailed Description
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Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart disease. While the presence of cardiac events may be a class effect of proteasome inhibitors (PI), the effect may be more profound with the irreversible inhibition of carfilzomib compared with reversible inhibition with bortezomib. Data available from currently published clinical trials may be inadequate to fully understand the incidence and severity of cardiac injury in patients treated with proteasome inhibitors because the trials were not designed to fully assess cardiac events. The purpose of this study is to better define and understand potential cardiac toxicity and begin to understand optimal management strategies.

Official Title
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Prospective Observation of Cardiac Safety With Proteasome Inhibition

Conditions
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Heart Failure, Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Myeloma (MM) treatment with bortezomib<br>No intervention planned. | |
| Multiple Myeloma (MM) treatment with carfilzomib<br>No intervention planned. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cardiac events of patients receiving PIs for MM. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiac Toxicity, Multiple Myeloma, Bortezomib, Carfilzomib