PROTECT: Prospective Observation of Cardiac Safety With Proteasome Inhibition

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02178579

Collaborator

Takeda (Industry)

Enrollment

Locations

56.4

Actual Duration (Months)

47.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Multiple Myeloma

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

95 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observation of Cardiac Safety With Proteasome Inhibition

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Jul 15, 2019

Actual Study Completion Date :

Jul 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Multiple Myeloma (MM) treatment with bortezomib No intervention planned.
Multiple Myeloma (MM) treatment with carfilzomib No intervention planned.

Outcome Measures

Primary Outcome Measures

Frequency of cardiac events of patients receiving PIs for MM. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania/Smilow Center for Translational Research	Philadelphia	Pennsylvania	United States	19104-5159
2	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232