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Trial record 1 of 1 for:    NCT02178579
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Prospective Observation of Cardiac Safety With Proteasome Inhibition (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02178579
Recruitment Status : Active, not recruiting
First Posted : July 1, 2014
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Robert Cornell, Vanderbilt University Medical Center

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
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.

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observation of Cardiac Safety With Proteasome Inhibition
Actual Study Start Date : November 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Multiple Myeloma (MM) treatment with bortezomib
No intervention planned.
Multiple Myeloma (MM) treatment with carfilzomib
No intervention planned.

Primary Outcome Measures :
  1. Frequency of cardiac events of patients receiving PIs for MM. [ Time Frame: 18 months ]

Biospecimen Retention:   Samples With DNA
Blood sample banked for future research.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Myeloma patients being treated with bortezomib or carfilzomib, per oncology physician decision.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02178579

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United States, Pennsylvania
University of Pennsylvania/Smilow Center for Translational Research
Philadelphia, Pennsylvania, United States, 19104-5159
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Robert Cornell
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Principal Investigator: Robert F Cornell, MD Vanderbilt University Medical Center

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Responsible Party: Robert Cornell, Assistant Professor, Vanderbilt University Medical Center Identifier: NCT02178579     History of Changes
Other Study ID Numbers: 140404
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data.
Keywords provided by Robert Cornell, Vanderbilt University Medical Center:
Heart Failure
Cardiac Toxicity
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Heart Failure
Heart Diseases
Cardiovascular Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents