Clinical trial · Interventional
MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart Disease Risk Factors | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncology-Embedded Cardiovascular Risk Assessment Pathway | Other | — | UNRESOLVED |
| Primary Care Provider-Directed Cardiovascular Risk Assessment Pathway | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Oncology-Embedded Cardiovascular Assessment
- description
- 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.
- interventionNames
- Other: Oncology-Embedded Cardiovascular Risk Assessment Pathway
- type
- ACTIVE_COMPARATOR
- label
- Primary Care Provider-Directed Cardiovascular Assessment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available