Recruiting

Isatuximab

Sponsor:

Pack Health

Code:

NCT05053607

Conditions

Multiple Myeloma

Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Health Coaching Program

Fitbit

Study Details

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.

Conditions

Multiple Myeloma

Refractory Multiple Myeloma

Study ID

NCT05053607

Start date

Jun 17, 2022

Status verified date

Dec, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

  • Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW) [ Time Frame: Change in baseline perception of treatment experience at 3 months ]
  • Qualitative Interview [ Time Frame: Within the last month of study participation ]

Central Contacts and Locations

Central contacts

Kelly J Brassil, PhD

205-721-7542dgxpharesearch@questdiagnostics.com

Jennifer Loftis, DNP

205-721-7542dgxpharesearch@questdiagnostics.com

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Trenton Grossfeld, BS

206-606-1774tgrossfeld@seattlecca.org

More Information

Sponsor

Pack Health

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • isatuximab
  • wearable electronic devices
  • qualitative research
  • patient reported outcome measures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Pack Health on 2024-12-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.