MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma

NCT07783607 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004410/UVMCC2608
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Multiple Myeloma; Heart Disease Risk Factors

Keywords

Oncology-Embedded Care; Cardio-Oncology

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  From treatment initiation through 6 months after treatment initiation

• Change From Baseline in PROMIS Physical Function Short Form 6b Score

  Baseline and Months 3, 6, and 12

• Cumulative Incidence of Composite Cardiovascular Events

  From baseline through Month 24

Study Arms (3)

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.

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.

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.

Other: Oncology-Embedded Cardiovascular Risk Assessment Pathway

Interventions

Oncology-Embedded Cardiovascular Risk Assessment Pathway OTHER

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.

Oncology-Embedded Cardiovascular Assessment; Urgent-Treatment Oncology-Embedded Assessment

Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway OTHER

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.

Primary Care Provider-Directed Cardiovascular Assessment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants meeting the urgent-treatment criteria may enroll in the separate nonrandomized urgent-treatment cohort.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Central Study Contacts

Mansour Gergi, MD

CONTACT

802-656-2021; mansour.gergi@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): February 1, 2028
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)