Prospective Observation of Cardiac Safety With Proteasome Inhibition
Prospective Observation of Cardiac Safety With Proteasome Inhibition
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.
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.
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