University of Vermont Medical Center
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.
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 o…
Inclusion Criteria: * 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 underst…
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.
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.