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Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab

RecruitingNAAges 18 Years - anyAllPack Health
NCT05053607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real Wo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 or older * Diagnosis of relapsed/refractory multiple myeloma corresponding to the Food and Drug Administration (FDA) package insert for isatuximab-irfc (Sarclisa®). * Confirmed or planned treatment with intravenous isatuximab-irfc for relapsed/refractory multiple myeloma as standard-of-care therapy. Concurrent therapy with other agents (e.g., pomalidomide) is allowed. * Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and/or access a mobile application. * Willingness to wear and have data collected by a Fitbit * Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2 Exclusion Criteria: * Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) * Individuals for whom there is documentation of inability to provide consent in the medical record. * Individuals receiving isatuximab-irfc subcutaneously
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What it tests

  • Digital Health Coaching Program
  • Fitbit
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Where

2 sites
The University of Texas MD Anderson Cancer Center
Houston, United States
University of Washington
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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