Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
NCT ID: NCT05053607
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-06-17
2025-12-31
Brief Summary
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Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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1. Single Arm Cohort Receiving Digital Health Coaching
All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.
Participants have the option to participate in a one time interview about their treatment experience.
Digital Health Coaching Program
consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
Fitbit
A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
Interventions
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Digital Health Coaching Program
consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
Fitbit
A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
Eligibility Criteria
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Inclusion Criteria
* 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 for whom there is documentation of inability to provide consent in the medical record.
* Individuals receiving isatuximab-irfc subcutaneously
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Sanofi
INDUSTRY
University of Washington
OTHER
Pack Health
INDUSTRY
Responsible Party
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Principal Investigators
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Melody R Becnel, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Rahul Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Trenton Grossfeld, BS
Role: primary
Rahul Banerjee, MD
Role: backup
References
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Other Identifiers
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2021-0309
Identifier Type: -
Identifier Source: org_study_id