NCT05053607

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab

Recruiting now NA Last updated 11 December 2024

What this trial tests

NA trial testing Digital Health Coaching Program in Multiple Myeloma in 50 participants. Currently enrolling.

Timeline

17 June 2022

Primary endpoint
31 August 2025

31 December 2025

Quick facts

Lead sponsor	Pack Health
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	17 June 2022
Primary completion	31 August 2025
Estimated completion	31 December 2025
Sites	2 locations across United States

Drugs / interventions tested

• Digital Health Coaching Program
• Fitbit

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →
• Refractory Multiple Myeloma — all drugs for Refractory Multiple Myeloma →

Sponsor

Pack Health

Who can join

18 and older, any sex, with Multiple Myeloma or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Digital therapeutics in the clinic.
   Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536