Multiple MyelomaMM-CARENCT07783607
MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma
A study testing Oncology-Embedded Cardiovascular Risk Assessment Pathway and Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway in people with Multiple Myeloma and Heart Disease Risk Factors, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
People with multiple myeloma may have health conditions or receive treatments that increase their risk of heart and blood-vessel problems. This pilot study will evaluate whether a structured heart-health assessment can be completed successfully and on time when adults with multiple myeloma start a new line of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Heart Disease Risk Factors
- What is being tested?
- Oncology-Embedded Cardiovascular Risk Assessment Pathway and Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2028to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Confirmed diagnosis of multiple myeloma.
- Age 18 years or older.
- Preparing to begin a new line of systemic multiple myeloma treatment in the newly diagnosed or relapsed or refractory setting.
- Planned ongoing oncology care with anticipated clinical visits sufficient to coordinate study assessments at Months 3, 6, and 12.
- For participants eligible for randomization, an established primary care provider who can be identified at enrollment and contacted by the study team if the participant is assigned to the primary care provider-directed pathway.
- Ability to understand the study and willingness to provide written informed consent.
Who cannot join
- An acute cardiovascular condition requiring emergency evaluation or specialty cardiology management rather than routine cardiovascular risk assessment, as determined by the treating clinician.
- Any condition that, in the investigator's judgment, would prevent meaningful participation in the study intervention or required assessments.
- Hospitalization or an urgent need to begin multiple myeloma treatment is not an exclusion.
- Participants meeting the urgent-treatment criteria may enroll in the separate nonrandomized urgent-treatment cohort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
Mansour Gergi, MD, 802-656-2021, mansour.gergi@med.uvm.edu
About this study
Official title: A Pilot Feasibility Study of Oncology-Embedded Versus Primary Care-Directed Cardiovascular Risk Assessment in Adults With Multiple Myeloma Starting a New Line of Therapy
People with multiple myeloma may have health conditions or receive treatments that increase their risk of heart and blood-vessel problems. This pilot study will evaluate whether a structured heart-health assessment can be completed successfully and on time when adults with multiple myeloma start a new line of treatment.
Participants who do not require urgent treatment in the hospital will be assigned by chance to receive the assessment from either an internal medicine clinician working with the oncology team or their primary care provider. Participants who require urgent inpatient treatment will receive the oncology-embedded assessment during their hospital stay.
Researchers expect that both approaches will be practical, but the approaches may differ in how often and how quickly the assessments are completed. The study will also collect information about care recommendations, quality of life, physical activity, diet, usual-care blood test and electrocardiogram results, and heart-related health events. Because this is a small pilot study, it is not designed to determine whether one approach provides better health outcomes than the other.
Read the detailed description
MM-CARE is a prospective, pragmatic, open-label, randomized pilot feasibility study evaluating two approaches to cardiovascular risk assessment for adults with multiple myeloma who are starting a new line of systemic therapy.
After informed consent, eligibility confirmation, and completion of baseline study assessments, participants who do not require urgent inpatient treatment will be randomized 1:1 to the oncology-embedded pathway or the primary care provider (PCP)-directed pathway. Randomization will be stratified according to whether the participant's PCP practices within the University of Vermont Health Network. Participants and clinicians will know the assigned pathway.
Participants assigned to the oncology-embedded pathway will receive a focused cardiovascular risk-assessment visit with an internal medicine clinician who works with the oncology team. The assessment may be conducted in person or by secure video and will include review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend additional clinical evaluation, referrals, or medications based on the participant's individual needs. Clinical follow-up will occur at approximately Months 3, 6, and 12.
For participants assigned to the PCP-directed pathway, the study team will send the participant's PCP a structured letter within five business days after randomization. The letter will request a focused cardiovascular risk assessment and will include relevant clinical information and available laboratory and electrocardiogram results. The PCP will be asked to complete the assessment as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The study team will track whether the assessment occurred and collect information about recommendations, medication changes, and referrals.
Participants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital will enter a separate nonrandomized urgent-treatment cohort. These participants will receive the oncology-embedded cardiovascular assessment during the qualifying hospitalization and will be analyzed separately from the randomized groups.
The study does not require a specific cardiovascular medicine, test, referral, diet, exercise plan, or change to multiple myeloma treatment. All clinical decisions will be made by the participant and the responsible clinicians. Multiple myeloma treatment may begin before or after the cardiovascular assessment and will not be delayed to complete study activities.
Study assessments will occur at baseline and approximately Months 3, 6, and 12. Participants will complete questionnaires about physical function, quality of life, physical activity, diet, the perceived helpfulness of the cardiovascular assessment, and whether they followed recommendations. The study team will also review relevant medical information and available results from blood tests and electrocardiograms performed as part of usual clinical care. Participants may separately agree to provide an additional 10 mL blood sample at each of these four time points for storage and future research.
Active study participation will continue through Month 12. At Month 24, the study team will conduct a medical-record review for cardiovascular events, hospitalizations, new cardiovascular diagnoses, deaths, and cardiovascular-related changes or interruptions to multiple myeloma treatment. No participant visit or additional procedure is required at Month 24.
The primary purpose of this pilot study is to evaluate whether the cardiovascular assessment pathways can be implemented and completed within the planned timeframe. The study is not designed or statistically powered to establish that one pathway produces better clinical outcomes than the other. Findings will be used to inform the design of a larger future study.
- Conditions
- Multiple Myeloma, Heart Disease Risk Factors
- Being tested
- Oncology-Embedded Cardiovascular Risk Assessment Pathway, Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway
- Keywords
- Oncology-Embedded Care, Cardio-Oncology
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncology-Embedded Cardiovascular Risk Assessment PathwayOther
A focused cardiovascular risk assessment is provided by an internal medicine clinician who works with the oncology team. The assessment may occur in person or by secure video. The clinician reviews cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications. Clinical follow-up occurs at approximately Months 3, 6, and 12.
Primary Care Provider-Directed Cardiovascular Risk Assessment PathwayOther
Within five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment. The communication includes relevant clinical information and available laboratory and electrocardiogram results. The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The primary care provider determines the appropriate counseling, testing, referrals, or medications. The study team tracks assessment completion and related recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Oncology-Embedded Cardiovascular Assessment | Experimental | Participants receive a focused cardiovascular risk assessment from an internal medicine clinician who works with the oncology team. The assessment may occur in person or by secure video and includes review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications. Clinical follow-up occurs at approximately Months 3, 6, and 12. Receives: Other: Oncology-Embedded Cardiovascular Risk Assessment Pathway |
| Primary Care Provider-Directed Cardiovascular Assessment | Active comparator | Within five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment. Relevant clinical information and available laboratory and electrocardiogram results are provided. The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The primary care provider determines the appropriate counseling, testing, referrals, or medications. The study team tracks completion of the assessment and related recommendations. Receives: Other: Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway |
| Urgent-Treatment Oncology-Embedded Assessment | Experimental | Participants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital enter this nonrandomized cohort. Participants receive the oncology-embedded cardiovascular risk assessment during the qualifying hospitalization. Multiple myeloma treatment is not delayed to complete the assessment. Participants in this cohort are analyzed separately from participants in the two randomized arms. Receives: Other: Oncology-Embedded Cardiovascular Risk Assessment Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Patients Who Enroll
Number of eligible patients who provide informed consent and enroll divided by the total number of eligible patients approached, multiplied by 100. The proportion will be reported with a 95% confidence interval.
Measured: During the study recruitment period, up to 24 months
Proportion of Participants Completing the Cardiovascular Assessment Before Treatment
Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed on or before the first dose of the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100. Results will be summarized by study arm with 95% confidence intervals.
Measured: From study enrollment through the first dose of the new systemic multiple myeloma treatment line
Proportion of Participants Completing the Cardiovascular Assessment Within 6 Months
Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed within six months after starting the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100. Results will be summarized by study arm with 95% confidence intervals.
Measured: From treatment initiation through 6 months after treatment initiation
Uptake and Adherence to Cardiovascular Medication Recommendations
Among participants who receive a cardiovascular medication recommendation, the percentage who initiate or continue the recommended medication and report adherence. Medication initiation, continuation, discontinuation, and adherence will be summarized separately by study arm and assessment time point.
Measured: Assessed at Months 3, 6, and 12 after the baseline study visit
Uptake and Adherence to Lifestyle Recommendations
Among participants who receive a physical activity or dietary recommendation, the percentage who report following the recommendation. Physical activity and dietary recommendations will be summarized separately by study arm and assessment time point.
Measured: Assessed at Months 3, 6, and 12 after the baseline study visit
Secondary outcomes (3)
Completion of the PCP-Directed Cardiovascular Assessment by PCP Affiliation
Among participants assigned to the PCP-directed pathway, the percentage who complete the assigned cardiovascular risk-assessment visit will be summarized separately for participants with a UVM Health Network-affiliated PCP and participants with a non-UVM Health Network-affiliated PCP. Completion requires documentation that the PCP reviewed cardiovascular risk and provided an assessment or recommendations.
Measured: From treatment initiation through 6 months after treatment initiation
Change From Baseline in PROMIS Physical Function Short Form 6b Score
Physical function is measured using the 6-item Patient-Reported Outcomes Measurement Information System Physical Function Short Form 6b. Items are scored from 1 to 5, with raw scores ranging from 6 to 30. Raw scores are converted to standardized T-scores according to PROMIS scoring procedures. Higher scores indicate better physical function. Change from baseline will be summarized at each follow-up time point and compared between the randomized arms.
Measured: Baseline and Months 3, 6, and 12
Cumulative Incidence of Composite Cardiovascular Events
The percentage of participants who experience at least one of the following events will be estimated: myocardial infarction, ischemic stroke, peripheral arterial thrombotic event, new-onset heart failure or hospitalization for heart failure, new clinically significant arrhythmia, or cardiovascular-related death. The composite endpoint and its individual components will be summarized by randomized arm and for the urgent-treatment cohort.
Measured: From baseline through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Feb 2028 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who do not require urgent inpatient treatment are randomized 1:1 in parallel to either an oncology-embedded or primary care provider-directed cardiovascular risk assessment pathway. Participants remain in their assigned group for the duration of the study, with no crossover. Participants hospitalized because of a multiple myeloma-related emergency requiring inpatient treatment enter a separate nonrandomized urgent-treatment cohort, receive the oncology-embedded assessment, and are analyzed separately.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansour Gergi, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783607
- Sponsor's protocol ID
- STUDY00004410/UVMCC2608
- Acronym
- MM-CARE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Oncology-Embedded Versus Primary Care-Directed Cardiovascular Risk Assessment in Adults With Multiple Myeloma Starting a New Line of Therapy
- ClinicalTrials.gov ID
- NCT07783607
- Acronym / sponsor ID
- MM-CARE / STUDY00004410/UVMCC2608
- Conditions
- Multiple Myeloma, Heart Disease Risk Factors
- Keywords
- Oncology-Embedded Care, Cardio-Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2028 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
People with multiple myeloma may have health conditions or receive treatments that increase their risk of heart and blood-vessel problems. This pilot study will evaluate whether a structured heart-health assessment can be completed successfully and on time when adults with multiple myeloma start a new line of treatment.
Participants who do not require urgent treatment in the hospital will be assigned by chance to receive the assessment from either an internal medicine clinician working with the oncology team or their primary care provider. Participants who require urgent inpatient treatment will receive the oncology-embedded assessment during their hospital stay.
Researchers expect that both approaches will be practical, but the approaches may differ in how often and how quickly the assessments are completed. The study will also collect information about care recommendations, quality of life, physical activity, diet, usual-care blood test and electrocardiogram results, and heart-related health events. Because this is a small pilot study, it is not designed to determine whether one approach provides better health outcomes than the other.
Detailed description
MM-CARE is a prospective, pragmatic, open-label, randomized pilot feasibility study evaluating two approaches to cardiovascular risk assessment for adults with multiple myeloma who are starting a new line of systemic therapy.
After informed consent, eligibility confirmation, and completion of baseline study assessments, participants who do not require urgent inpatient treatment will be randomized 1:1 to the oncology-embedded pathway or the primary care provider (PCP)-directed pathway. Randomization will be stratified according to whether the participant's PCP practices within the University of Vermont Health Network. Participants and clinicians will know the assigned pathway.
Participants assigned to the oncology-embedded pathway will receive a focused cardiovascular risk-assessment visit with an internal medicine clinician who works with the oncology team. The assessment may be conducted in person or by secure video and will include review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend additional clinical evaluation, referrals, or medications based on the participant's individual needs. Clinical follow-up will occur at approximately Months 3, 6, and 12.
For participants assigned to the PCP-directed pathway, the study team will send the participant's PCP a structured letter within five business days after randomization. The letter will request a focused cardiovascular risk assessment and will include relevant clinical information and available laboratory and electrocardiogram results. The PCP will be asked to complete the assessment as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The study team will track whether the assessment occurred and collect information about recommendations, medication changes, and referrals.
Participants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital will enter a separate nonrandomized urgent-treatment cohort. These participants will receive the oncology-embedded cardiovascular assessment during the qualifying hospitalization and will be analyzed separately from the randomized groups.
The study does not require a specific cardiovascular medicine, test, referral, diet, exercise plan, or change to multiple myeloma treatment. All clinical decisions will be made by the participant and the responsible clinicians. Multiple myeloma treatment may begin before or after the cardiovascular assessment and will not be delayed to complete study activities.
Study assessments will occur at baseline and approximately Months 3, 6, and 12. Participants will complete questionnaires about physical function, quality of life, physical activity, diet, the perceived helpfulness of the cardiovascular assessment, and whether they followed recommendations. The study team will also review relevant medical information and available results from blood tests and electrocardiograms performed as part of usual clinical care. Participants may separately agree to provide an additional 10 mL blood sample at each of these four time points for storage and future research.
Active study participation will continue through Month 12. At Month 24, the study team will conduct a medical-record review for cardiovascular events, hospitalizations, new cardiovascular diagnoses, deaths, and cardiovascular-related changes or interruptions to multiple myeloma treatment. No participant visit or additional procedure is required at Month 24.
The primary purpose of this pilot study is to evaluate whether the cardiovascular assessment pathways can be implemented and completed within the planned timeframe. The study is not designed or statistically powered to establish that one pathway produces better clinical outcomes than the other. Findings will be used to inform the design of a larger future study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants who do not require urgent inpatient treatment are randomized 1:1 in parallel to either an oncology-embedded or primary care provider-directed cardiovascular risk assessment pathway. Participants remain in their assigned group for the duration of the study, with no crossover. Participants hospitalized because of a multiple myeloma-related emergency requiring inpatient treatment enter a separate nonrandomized urgent-treatment cohort, receive the oncology-embedded assessment, and are analyzed separately.
| Arm | Type | Receives |
|---|---|---|
| Oncology-Embedded Cardiovascular Assessment | Experimental | Other: Oncology-Embedded Cardiovascular Risk Assessment PathwayParticipants receive a focused cardiovascular risk assessment from an internal medicine clinician who works with the oncology team. The assessment may occur in person or by secure video and includes review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications. Clinical follow-up occurs at approximately Months 3, 6, and 12. |
| Primary Care Provider-Directed Cardiovascular Assessment | Active comparator | Other: Primary Care Provider-Directed Cardiovascular Risk Assessment PathwayWithin five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment. Relevant clinical information and available laboratory and electrocardiogram results are provided. The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The primary care provider determines the appropriate counseling, testing, referrals, or medications. The study team tracks completion of the assessment and related recommendations. |
| Urgent-Treatment Oncology-Embedded Assessment | Experimental | Other: Oncology-Embedded Cardiovascular Risk Assessment PathwayParticipants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital enter this nonrandomized cohort. Participants receive the oncology-embedded cardiovascular risk assessment during the qualifying hospitalization. Multiple myeloma treatment is not delayed to complete the assessment. Participants in this cohort are analyzed separately from participants in the two randomized arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of multiple myeloma.
- Age 18 years or older.
- Preparing to begin a new line of systemic multiple myeloma treatment in the newly diagnosed or relapsed or refractory setting.
- Planned ongoing oncology care with anticipated clinical visits sufficient to coordinate study assessments at Months 3, 6, and 12.
- For participants eligible for randomization, an established primary care provider who can be identified at enrollment and contacted by the study team if the participant is assigned to the primary care provider-directed pathway.
Key exclusion criteria (4 listed)
- An acute cardiovascular condition requiring emergency evaluation or specialty cardiology management rather than routine cardiovascular risk assessment, as determined by the treating clinician.
- Any condition that, in the investigator's judgment, would prevent meaningful participation in the study intervention or required assessments.
- Hospitalization or an urgent need to begin multiple myeloma treatment is not an exclusion.
- Participants meeting the urgent-treatment criteria may enroll in the separate nonrandomized urgent-treatment cohort.
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 |
|---|---|---|
| Oncology-Embedded Cardiovascular Risk Assessment PathwayA focused cardiovascular risk assessment is provided by an internal medicine clinician who works with the oncology team. The assessment may occur in person or by secure video. The clinician reviews cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications. Clinical follow-up occurs at approximately Months 3, 6, and 12. | Other | Oncology-Embedded Cardiovascular Assessment, Urgent-Treatment Oncology-Embedded Assessment |
| Primary Care Provider-Directed Cardiovascular Risk Assessment PathwayWithin five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment. The communication includes relevant clinical information and available laboratory and electrocardiogram results. The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The primary care provider determines the appropriate counseling, testing, referrals, or medications. The study team tracks assessment completion and related recommendations. | Other | Primary Care Provider-Directed Cardiovascular Assessment |
Primary outcome
Proportion of Eligible Patients Who Enroll
Time frame: During the study recruitment period, up to 24 months
Number of eligible patients who provide informed consent and enroll divided by the total number of eligible patients approached, multiplied by 100. The proportion will be reported with a 95% confidence interval.
Proportion of Participants Completing the Cardiovascular Assessment Before Treatment
Time frame: From study enrollment through the first dose of the new systemic multiple myeloma treatment line
Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed on or before the first dose of the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100. Results will be summarized by study arm with 95% confidence intervals.
Proportion of Participants Completing the Cardiovascular Assessment Within 6 Months
Time frame: From treatment initiation through 6 months after treatment initiation
Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed within six months after starting the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100. Results will be summarized by study arm with 95% confidence intervals.
Uptake and Adherence to Cardiovascular Medication Recommendations
Time frame: Assessed at Months 3, 6, and 12 after the baseline study visit
Among participants who receive a cardiovascular medication recommendation, the percentage who initiate or continue the recommended medication and report adherence. Medication initiation, continuation, discontinuation, and adherence will be summarized separately by study arm and assessment time point.
Uptake and Adherence to Lifestyle Recommendations
Time frame: Assessed at Months 3, 6, and 12 after the baseline study visit
Among participants who receive a physical activity or dietary recommendation, the percentage who report following the recommendation. Physical activity and dietary recommendations will be summarized separately by study arm and assessment time point.
3 secondary outcomes
Completion of the PCP-Directed Cardiovascular Assessment by PCP Affiliation
Time frame: From treatment initiation through 6 months after treatment initiation
Change From Baseline in PROMIS Physical Function Short Form 6b Score
Time frame: Baseline and Months 3, 6, and 12
Cumulative Incidence of Composite Cardiovascular Events
Time frame: From baseline through Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncology-Embedded Cardiovascular Risk Assessment Pathway and Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway in people with Multiple Myeloma and Heart Disease Risk Factors, run by University of Vermont Medical Center 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 6 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: opening soon, as of the sponsor's last update on 25 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mansour Gergi, MD (802-656-2021, mansour.gergi@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Patients Who Enroll (time frame: During the study recruitment period, up to 24 months). The study lists 5 primary outcomes in all. 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 25 Aug 2026.