Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

November 27, 2023 updated by: University of Chicago

Risk Factors for Dyspnea and Cardiotoxicity in Patients With Multiple Myeloma Who Receive Carfilzomib: A Prospective Pilot Study

This study will explore why some multiple myeloma patients who receive carfilzomib (an anti-cancer medication) experience shortness of breath while others do not. The purpose of this research is to gather information on the effectiveness of the EndoPAT device, which is FDA-approved to assess the health of a patient's blood vessels. These assessments will help doctors leading the study determine the reasons why patients may develop shortness of breath (dyspnea) when being treated with carfilzomib and ways to better prevent this shortness of breath.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ajay Major, MD
  • Phone Number: (773) 834-6664

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with multiple myeloma who are being treated with carfilzomib.

Description

Inclusion Criteria:

  • Age ≥ 18
  • Confirmed diagnosis of multiple myeloma
  • Newly-diagnosed multiple myeloma, or relapsed/refractory multiple myeloma with receipt of 1-3 previous lines of therapy and with a 2-week washout from prior therapy
  • Receiving carfilzomib as either standard-of-care therapy or as part of a clinical trial

Exclusion Criteria:

  • Previous receipt of anthracycline chemotherapy
  • Previous receipt of carfilzomib
  • Four or more previous lines of therapy
  • Active pregnancy at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Normal Baseline Endothelial Function
Device: EndoPAT
An FDA approved device to test the health of a patient's blood vessels, which involves putting an oxygen probe on the participant's finger.
Device: Blood Pressure Cuff
A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.
Diagnostic test: Echocardiogram
A test used to conduct an ultrasound of participant's heart.
Other: Quality of Life Assessment
A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.
Other: Blood Tests
Routinely collected for all participants who begin carfilzomib treatment.
Participants with Abnormal Baseline Endothelial Function
Device: EndoPAT
An FDA approved device to test the health of a patient's blood vessels, which involves putting an oxygen probe on the participant's finger.
Device: Blood Pressure Cuff
A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.
Diagnostic test: Echocardiogram
A test used to conduct an ultrasound of participant's heart.
Other: Quality of Life Assessment
A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.
Other: Blood Tests
Routinely collected for all participants who begin carfilzomib treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients
Time Frame: 2 months
The association between baseline endothelial function and dyspnea in myeloma patients treated with carfilzomib. These associations will be assessed by comparing endothelial function within two cohorts: patients with abnormal baseline endothelial function, and patients with normal baseline endothelial function. Baseline endothelial function will be measured using EndoPat, an FDA-approved device used for health tests. Dyspnea rates will be assessed by participant-reported outcomes using the FACIT Dyspnea-10 Raw Dyspnea Score and Common Terminology Criteria for Adverse Events V5.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function
Time Frame: 2 months
The association between changes in carfilzomib-induced endothelial function and frequency of cardiovascular toxicities stratified by patients with abnormal and normal baseline endothelial function.Cardiovascular toxicities in this study will be defined as new or worsening symptomatic heart failure, hypertension, myocardial ischemia, stroke, pulmonary hypertension, arrhythmias and thromboembolic events that will be measured per CTCAE V5.
2 months
The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea
Time Frame: 2 months
The affects of carfilzomib dose/dosing schedule on how often participants experience dyspnea (shortness of breath) will be assessed by participant reported outcomes using the FACIT Dyspnea-10 (raw dyspnea score) and data collected on adverse events (side effects) using CTCAE V5.
2 months
Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function
Time Frame: 2 months
To determine whether changes in endothelial function are associated with cardiovascular physiological changes and cardiovascular risk factors within participants receiving carfilzomib. These associations will be measured by: hemodynamics (using the average 24-hour ambulatory blood pressure reported by participants after treatment using home blood pressure monitoring), echocardiography using echocardiogram, and data collected on patient's vascular and cardiovascular health at baseline.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jeanne DeCara, MD, University of Chicago - Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB20-1768

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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