Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPack Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Digital Health Coaching Program
Behavioralconsisting 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
DeviceA 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 1. Single Arm Cohort Receiving Digital Health CoachingOther 2 interventions
Trial outcomes
Primary outcomes
1
Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.
Time frame
Change in baseline perception of treatment experience at 3 months2
Qualitative Interview
A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.
Time frame
Within the last month of study participationSecondary outcomes
1
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically.
Time frame
Change in baseline perception of treatment experience at 3 months2
Change in Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20)
A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much).
Time frame
Change in baseline perception of treatment experience at 3 months3
Change in European QoL-5 Dimensions (EQ5D)
A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame
Change in baseline perception of treatment experience at 3 months4
Change in Cancer Behavior Inventory-Brief Form (CBI-B)
This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".
Time frame
Change in baseline perception of treatment experience at 3 monthsOther outcomes
1
Physical Activity
Physical activity, including step count and minutes of physical activity will be collected via Fitbits provided to study participants
Time frame
From date of enrollment up to 3 months2
Health Care Utilization
ER visits and unplanned hospitalizations
Time frame
From date of enrollment up to 3 months3
Digital Engagement
Frequency, types and duration of engagement with the digital health coaching platform
Time frame
From date of enrollment up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pack Health
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Sanofi
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov