Tracks patient experience with isatuximab for relapsed or refractory myeloma
Follows adults with returning or resistant myeloma on isatuximab, using coaching and wearables.
Key facts
- Who runs it
- Pack Health
- Where
- Houston and Seattle, United StatesSee the 2 sites
- Trial code
- Registry title
- Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 17 Jun 2022
- Planned end
- 31 Dec 2025
- Type of study
- Interventional
- Treatments tested
- Digital Health Coaching Program
- Fitbit
- Record updated
- 11 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsed or refractory multiple myeloma who are getting, or are about to start, isatuximab-irfc through a vein as standard care. They join a 3-month digital coaching program and wear a Fitbit.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory multiple myeloma, as described in the FDA package insert for isatuximab-irfc (Sarclisa®). Able to be physically active (ECOG performance status of 2 or lower).
- Earlier treatment
- Confirmed or planned treatment with isatuximab-irfc given through a vein (intravenously) as standard care. Taking other drugs at the same time, such as pomalidomide, is allowed.
Main reasons for not taking part
- Terminally ill: the doctor thinks the person has 6 months or less to live, or the person is on comfort care only
- Documented in the medical record as unable to give consent
- Receiving isatuximab-irfc as an injection under the skin (subcutaneously)
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Individuals receiving isatuximab-irfc subcutaneously
- 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
Where in United States
- The University of Texas MD Anderson Cancer CenterHouston, United StatesContact: Kelly J Brassil, PhDNo longer taking part
- University of WashingtonSeattle, United StatesContact: Trenton Grossfeld, BSTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- 1. Single Arm Cohort Receiving Digital Health CoachingOther group
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.
Treatment: Digital Health Coaching Program and Fitbit
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tracks patient experience with isatuximab for relapsed or refractory myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 December 2024