Evaluating patient experiences with isatuximab for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Washington
  Seattle, Washington, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Active not 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Isatuximab-VRd for transplant-ineligible newly diagnosed multiple myeloma

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• Personalized dendritic cell–myeloma fusion vaccine combined with elranatamab for relapsed or refractory multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.