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Not Yet Recruiting
NCT07783607
MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma
Conditions: Multiple Myeloma, Heart Disease Risk Factors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 33
Sponsor: University of Vermont Medical Center
Location: University of Vermont Medical Center Burlington Vermont
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.
Eligibility Criteria
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 understand the study and willingness to provide written informed consent.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07783607). StuddyBuddy aggregates publicly available trial information.