Clinical trial NCT05053607: Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Refractory Multiple Myeloma
Keywords: isatuximab
wearable electronic devices
qualitative research
patient reported outcome measures
Lead sponsor: Pack Health
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Sanofi
name: University of Washington
First posted: 2021-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of 50 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking. Individuals from both study sites will be enrolled to this single cohort.
Primary purpose: OTHER

Brief summary: 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: 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

Primary outcomes:
measure: Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Qualitative Interview
timeFrame: Within the last month of study participation
Secondary outcomes:
measure: Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20)
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in European QoL-5 Dimensions (EQ5D)
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Cancer Behavior Inventory-Brief Form (CBI-B)
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Patient Global Impression of Severity (PGIS) Scale
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Patient Global Impression of Change (PGIC) Scale
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index
timeFrame: Change in baseline perception of treatment experience at 3 months
measure: Change in Comprehensive Score for Financial Toxicity (COST) Instrument
timeFrame: Change in baseline perception of treatment experience at 3 months
Other outcomes:
measure: Physical Activity
timeFrame: From date of enrollment up to 3 months
measure: Health Care Utilization
timeFrame: From date of enrollment up to 3 months
measure: Digital Engagement
timeFrame: From date of enrollment up to 3 months
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Melody R Becnel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Rahul Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
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