MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Oncology-Embedded Cardiovascular Risk Assessment Pathway
Other interventionA 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 Pathway
Other interventionWithin 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.
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: Oncology-Embedded Cardiovascular AssessmentExperimental treatment 1 intervention
Group B: Primary Care Provider-Directed Cardiovascular AssessmentActive comparator 1 intervention
Group C: Urgent-Treatment Oncology-Embedded AssessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the study recruitment period, up to 24 months2
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.
Time frame
From study enrollment through the first dose of the new systemic multiple myeloma treatment line3
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.
Time frame
From treatment initiation through 6 months after treatment initiation4
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.
Time frame
Assessed at Months 3, 6, and 12 after the baseline study visitSecondary outcomes
1
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.
Time frame
From treatment initiation through 6 months after treatment initiation2
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.
Time frame
Baseline and Months 3, 6, and 123
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.
Time frame
From baseline through Month 24Sponsors and contacts
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Source ClinicalTrials.gov
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