Prospective Observation of Cardiac Safety With Proteasome Inhibition

NCT ID: NCT02178579

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-07-15

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.

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.

Conditions

Heart Failure; Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Myeloma (MM) treatment with bortezomib

No intervention planned.

No interventions assigned to this group

Multiple Myeloma (MM) treatment with carfilzomib

No intervention planned.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F Cornell, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

University of Pennsylvania/Smilow Center for Translational Research

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Cornell RF, Ky B, Weiss BM, Dahm CN, Gupta DK, Du L, Carver JR, Cohen AD, Engelhardt BG, Garfall AL, Goodman SA, Harrell SL, Kassim AA, Jadhav T, Jagasia M, Moslehi J, O'Quinn R, Savona MR, Slosky D, Smith A, Stadtmauer EA, Vogl DT, Waxman A, Lenihan D. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma. J Clin Oncol. 2019 Aug 1;37(22):1946-1955. doi: 10.1200/JCO.19.00231. Epub 2019 Jun 12.

Reference Type: DERIVED

PMID: 31188726 (View on PubMed)

Other Identifiers

140404

Identifier Type: -

Identifier Source: org_study_id