Prospective Observation of Cardiac Safety With Proteasome Inhibition
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Cardiology, Hematology, Hematology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/12/2019 |
Start Date: | November 2014 |
End Date: | February 2020 |
The purpose of this study is to better define and understand potential cardiac toxicity and
begin to understand optimal management strategies.
begin to understand optimal management strategies.
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.
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.
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
We found this trial at
2
sites
Philadelphia, Pennsylvania 19104
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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