Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

NCT04827563 | Terminated

• 1 other identifier: IRB20-1768
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiotoxicity; Multiple Myeloma; Shortness of Breath; Dyspnea

Keywords

multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function

  2 months

• The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea

  2 months

• Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function

  2 months

Study Arms (2)

Participants with Normal Baseline Endothelial Function

Device: EndoPAT; Device: Blood Pressure Cuff; Diagnostic Test: Echocardiogram; Other: Quality of Life Assessment; Other: Blood Tests

Participants with Abnormal Baseline Endothelial Function

Device: EndoPAT; Device: Blood Pressure Cuff; Diagnostic Test: Echocardiogram; Other: Quality of Life Assessment; Other: Blood Tests

Interventions

EndoPAT DEVICE

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.

Participants with Abnormal Baseline Endothelial Function; Participants with Normal Baseline Endothelial Function

Blood Pressure Cuff DEVICE

A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.

Participants with Abnormal Baseline Endothelial Function; Participants with Normal Baseline Endothelial Function

Echocardiogram DIAGNOSTIC_TEST

A test used to conduct an ultrasound of participant's heart.

Participants with Abnormal Baseline Endothelial Function; Participants with Normal Baseline Endothelial Function

Quality of Life Assessment OTHER

A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.

Participants with Abnormal Baseline Endothelial Function; Participants with Normal Baseline Endothelial Function

Blood Tests OTHER

Routinely collected for all participants who begin carfilzomib treatment.

Participants with Abnormal Baseline Endothelial Function; Participants with Normal Baseline Endothelial Function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with multiple myeloma who are being treated with carfilzomib.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Dyspnea; Cardiotoxicity

Interventions

Echocardiography; Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Jeanne DeCara, MD

  University of Chicago - Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)