Multiple MyelomaNCT04827563
Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib
An observational study of Multiple Myeloma and Shortness of Breath, run by University of Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Shortness of Breath, Dyspnea
- What is being tested?
- EndoPAT, Blood Pressure Cuff and Echocardiogram
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 8 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with multiple myeloma who are being treated with carfilzomib.
Who may be able to join
- 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
Who cannot join
- Previous receipt of anthracycline chemotherapy
- Previous receipt of carfilzomib
- Four or more previous lines of therapy
- Active pregnancy at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Myeloma, Shortness of Breath, Dyspnea, Cardiotoxicity
- Being tested
- EndoPAT, Blood Pressure Cuff, Echocardiogram, Quality of Life Assessment, Blood Tests
- Keywords
- multiple myeloma
- Medical subject headings
- Multiple Myeloma, Dyspnea, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoPATDevice
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 CuffDevice
A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.
EchocardiogramDiagnostic test
A test used to conduct an ultrasound of participant's heart.
Quality of Life AssessmentOther
A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.
Blood TestsOther
Routinely collected for all participants who begin carfilzomib treatment.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Normal Baseline Endothelial Function | Not described Receives: Device: EndoPAT; Device: Blood Pressure Cuff; Diagnostic Test: Echocardiogram; Other: Quality of Life Assessment; Other: Blood Tests | |
| Participants with Abnormal Baseline Endothelial Function | Not described Receives: Device: EndoPAT; Device: Blood Pressure Cuff; Diagnostic Test: Echocardiogram; Other: Quality of Life Assessment; Other: Blood Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Why it stopped: Study terminated by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne DeCara, MD, Principal investigator, University of Chicago - Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827563
- Sponsor's protocol ID
- IRB20-1768
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Dyspnea and Cardiotoxicity in Patients With Multiple Myeloma Who Receive Carfilzomib: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04827563
- Acronym / sponsor ID
- IRB20-1768
- Conditions
- Multiple Myeloma, Shortness of Breath, Dyspnea, Cardiotoxicity
- Keywords
- multiple myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated by PI
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with multiple myeloma who are being treated with carfilzomib.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous receipt of anthracycline chemotherapy
- Previous receipt of carfilzomib
- Four or more previous lines of therapy
- Active pregnancy at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoPATAn 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 | Participants with Abnormal Baseline Endothelial Function, Participants with Normal Baseline Endothelial Function |
| Blood Pressure CuffA device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours. | Device | Participants with Abnormal Baseline Endothelial Function, Participants with Normal Baseline Endothelial Function |
| EchocardiogramA test used to conduct an ultrasound of participant's heart. | Diagnostic test | Participants with Abnormal Baseline Endothelial Function, Participants with Normal Baseline Endothelial Function |
| Quality of Life AssessmentA survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma. | Other | Participants with Abnormal Baseline Endothelial Function, Participants with Normal Baseline Endothelial Function |
| Blood TestsRoutinely collected for all participants who begin carfilzomib treatment. | Other | Participants with Abnormal Baseline Endothelial Function, Participants with Normal Baseline Endothelial Function |
Primary outcome
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.
3 secondary outcomes
Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function
Time frame: 2 months
The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea
Time frame: 2 months
Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Study terminated by PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne DeCara, MD principal investigator
University of Chicago - Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Shortness of Breath, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated by PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.