P-132: Trial in progress: a mixed methods approach to understanding treatment experience of individuals receiving standard of care Isatuximab using patient reported, wearable, and digital health outcomes

Background Relapsed/refractory multiple myeloma (R/R MM) is associated with potential for decreased quality of life and increased symptom burden. As new therapeutic approaches emerge for the R/R MM population, further insight is needed regarding the treatment experience of individuals in the real-world setting. Patient reported outcomes (PROs) have demonstrated utility not only in tracking symptom burden during treatment, but also improving outcomes, including overall survival for individuals from whom PROs are collected and responded to in the clinical setting. The use of multimodal data sources, informed by PROs, may provide a richer understanding of the real-world experience of R/R MM, its management, and its impact on quality of life. Through the triangulation of qualitative and quantitative data, this trial-in-progress aims to evaluate the experience of adults with R/R MM receiving standard of care isatuximab in the real-world setting. Methods Fifty adults with R/R MM receiving standard of care isatuximab 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 ePROs, and activity data from wearable devices, will be collected. PRO measures include the Patient’s Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), FACT-G (Item GP5-side effect bother), EORTC-QLQ-C30, QLQ-MY20, EQ5D. Demographic, as well as clinical data, including treatment history, healthcare utilization, and co-morbidities, will be collected via each participant’s electronic health record. These data will be complemented by qualitative data from a purposefully selected cohort of study participants for which a focus on treatment experience will be assessed, ranging from infusion burden to toxicity management, to overall quality of life. Triangulation of data will be used to evaluate the treatment experience of individuals on standard of care isatuximab specifically, and R/R MM generally. Outcomes will be analyzed with attention to the relationship between demographics, including race and ethnicity, and treatment experience as reflected in both the qualitative and quantitative data. Conclusions As the treatment landscape continues to evolve, insights into the experience of individuals in the real-world setting are important to recognize challenges and to optimize the management of R/R MM. By capturing insights via diverse PRO tools including both validated measures of quality of life and symptom burden, as well as physical activity and qualitative data, this study seeks to enhance the literature and implications for clinical practice for individuals receiving treatment for R/R MM in the real-world setting.