Evaluating patient experiences with isatuximab for multiple myeloma
Clinical and Patient Reported Outcomes for Individuals with Relapsed/Refractory Multiple Myeloma Treated with Isatuximab: Real-World Insights from Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching
This study is trying to learn about the experiences of adults with relapsed or refractory multiple myeloma who are receiving isatuximab, by using digital health tools to see how the treatment affects their daily lives over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pack Health Industry-sponsored |
| Drugs / interventions | isatuximab |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT05053607 on ClinicalTrials.gov |
What this trial studies
This study aims to gather insights from adults with relapsed or refractory multiple myeloma who are receiving isatuximab-irfc as part of their standard care. Participants will be enrolled in a digital health coaching program for three months, during which their treatment experiences, quality of life, and other health-related data will be collected using wearable devices and patient-reported outcome measures. The study will take place at two prominent cancer centers, focusing on understanding the real-world impact of treatment on patients' lives.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older diagnosed with relapsed or refractory multiple myeloma who are receiving isatuximab-irfc.
Not a fit: Patients who are terminally ill or have an ECOG performance status score greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of patient experiences and improve treatment approaches for those with relapsed or refractory multiple myeloma.
How similar studies have performed: Other studies have shown success in utilizing digital health tools and patient-reported outcomes to improve treatment understanding and patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas and 1 other locations
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Active_not_recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Melody R Becnel, MD — M.D. Anderson Cancer Center
- Study coordinator: Kelly J Brassil, PhD
- Email: dgxpharesearch@questdiagnostics.com
- Phone: 205-721-7542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.