Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma, Shortness of Breath, Dyspnea, Cardiotoxicity

Intervention / Treatment
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* Device: EndoPAT
* Device: Blood Pressure Cuff
* Diagnostic Test: Echocardiogram
* Other: Quality of Life Assessment
* Other: Blood Tests


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Normal Baseline Endothelial Function<br> | Device: EndoPAT<br>* 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.<br>Device: Blood Pressure Cuff<br>* A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.<br>Diagnostic Test: Echocardiogram<br>* A test used to conduct an ultrasound of participant's heart.<br>Other: Quality of Life Assessment<br>* A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.<br>Other: Blood Tests<br>* Routinely collected for all participants who begin carfilzomib treatment.<br>|
| Participants with Abnormal Baseline Endothelial Function<br> | Device: EndoPAT<br>* 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.<br>Device: Blood Pressure Cuff<br>* A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.<br>Diagnostic Test: Echocardiogram<br>* A test used to conduct an ultrasound of participant's heart.<br>Other: Quality of Life Assessment<br>* A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.<br>Other: Blood Tests<br>* Routinely collected for all participants who begin carfilzomib treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma