Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
Study of Patient Experience During Standard Treatment for Relapsed or Refractory Multiple Myeloma
Study Overview
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 World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Myeloma, Refractory Multiple Myeloma
-
Age: 18 years or above
-
Gender: All
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
The purpose of this research study is to learn about the treatment experience of adults with relapsed or refractory multiple myeloma (myeloma that has come back or has not responded well to treatment) who are receiving a standard treatment through a vein.
Participants will continue to receive their standard-of-care treatment. During the study, participants will take part in a digital health coaching program. They will share information about their symptoms, quality of life, treatment experience, and other topics by completing questionnaires. Participants will also wear a Fitbit so the study team can collect activity data. The study team will also collect some clinical and background information from participants’ medical records. Some participants will also take part in interviews about their treatment experience, such as time spent on infusions, side effects, and quality of life.
Who can participate:
Adults with relapsed or refractory multiple myeloma may be able to participate if they:
- Are 18 years or older
- Have relapsed or refractory multiple myeloma and are confirmed or planning to receive standard treatment through a vein
- Can use a smartphone or similar device to send and receive texts, emails, or use an app
- Are willing to wear a Fitbit for data collection
- Are able to do physical activity (able to be up and about more than half the day)
Study timeline and visits:
Participation includes a 3-month digital health coaching program.
Find a study site near you
,
Send a message
Enter your contact details to connect with study team
Primary Contact
Please choose between Voice or SMS based delivery of verification code
or