Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

NCT ID: NCT04827563

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2026-08-01

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.

Detailed Description

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Conditions

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Multiple Myeloma Shortness of Breath Dyspnea Cardiotoxicity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Normal Baseline Endothelial Function

EndoPAT

Intervention Type 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.

Blood Pressure Cuff

Intervention Type DEVICE

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

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

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

Quality of Life Assessment

Intervention Type OTHER

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

Blood Tests

Intervention Type OTHER

Routinely collected for all participants who begin carfilzomib treatment.

Participants with Abnormal Baseline Endothelial Function

EndoPAT

Intervention Type 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.

Blood Pressure Cuff

Intervention Type DEVICE

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

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

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

Quality of Life Assessment

Intervention Type OTHER

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

Blood Tests

Intervention Type OTHER

Routinely collected for all participants who begin carfilzomib treatment.

Interventions

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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.

Intervention Type DEVICE

Blood Pressure Cuff

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

Intervention Type DEVICE

Echocardiogram

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

Intervention Type DIAGNOSTIC_TEST

Quality of Life Assessment

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

Intervention Type OTHER

Blood Tests

Routinely collected for all participants who begin carfilzomib treatment.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeanne DeCara, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago - Comprehensive Cancer Center

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB20-1768

Identifier Type: -

Identifier Source: org_study_id

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