Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827563
• Other study ID #: IRB20-1768
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: Jeanne DeCara, MD
• Phone: (773) 834-6664
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Dyspnea
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Shortness of Breath

Intervention

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.
• 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.
• Blood Tests
Routinely collected for all participants who begin carfilzomib treatment.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients	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	Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function	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
Secondary	The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea	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
Secondary	Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function	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