Pilot Trial of the My Hematology Oncology Patient Experience (MyHOPE™) for Multiple Myeloma (MM) Digital Solution in Patients with MM

Background: There is growing evidence to suggest that continuous monitoring and a proper use of patient-reported outcomes (PROs) in the clinical setting may improve patient care by facilitating doctor-patient communication, promoting individualized supportive care, and increasing patient satisfaction (Velikova, J Clin Oncol. 2004;22(4):714-24; Yang, Support Care Cancer. 2018 Jan;26(1):41-60). This may be of particular importance for patients with MM, a condition characterized by considerable heterogeneity in PROs at different timepoints within a patient's disease journey (TA King et al, Semin Oncol Nurs. 2017;33(3):299-315;R Abonour et al, Ann Hematol. 2018;97(12):2425-36). There is also a growing body of evidence to support that digital platforms in healthcare can have an impact on patients' lives and improve the patient care experience across diverse medical settings. Web-based platforms that provide education and allow patients to track data have demonstrated improvement across a range of PROs measuring empowerment, self-efficacy, and mastery when compared against standard of care in a variety of disease states (MR Fu et al, Internet Interv. 2016;5:56-64; G Bouma et al, Support Care Cancer. 2017;25(7):2075-2083). This may be particularly relevant in light of the current coronavirus disease 2019 (COVID-19) global pandemic.

Patient-reported outcome data (e.g., symptoms) that can be readily shared with healthcare professionals (HCPs) can support clinical decision making and impact patient outcomes (E Basch et al, JAMA. 2017 Jul 11;318(2):197-8). Data collected through wearables (such as emoji scales and activity) have been shown to be correlated with traditional, validated PRO measures in patients with cancer (CA Thompson et al, Blood. 2017;130(Suppl 1):2179). Digital medication tracking has led to better medication adherence, increased prescription refills, and better clinical outcomes. Centralized disease management digital platforms have shown potential to reduce patients' risk of complications (S Kumar et al, Abstract for the 77th American Diabetes Association. 2017). Despite this body of evidence supporting the potential impact of the use of digital platforms, there is little evidence specifically in MM. The MyHOPE™ for MM Solution is a validated investigational digital technology platform designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM and to collect biometrics and self-reported data such as symptom tracking, medication adherence, and health-related quality of life (HRQoL) with the ability to share this data with the patient's care team. MyHOPE™ for MM is the first prospective study evaluating the impact of a digital intervention for patients with hematological malignancies.

Study Design and Methods: This is a multi-center, randomized, pilot trial of the MyHOPE™ for MM Solution. Approximately 126 adult patients (≥ 18 years of age) with a diagnosis of MM and who reside in the USA will be recruited from approximately 30 study sites within the USA, reflecting both community and academic centers. Patients will be stratified according to disease status (newly-diagnosed multiple myeloma transplant-eligible or ineligible, newly-diagnosed multiple myeloma in patients undergoing their first autologous stem cell transplant, or relapsed and/or refractory) and will be randomized in a 2:1 manner to either the Patient App + HCP Portal (Cohort 1) or Patient App Alone (Cohort 2). Primary objectives include feasibility of the platform and patient empowerment and self-efficacy. Other objectives include user satisfaction with the platform, health-related quality of life, and clinical outcomes. Enrolled patients will receive MM-treament regimen according to their physician's care plan. The study is in start-up and recruitment is expected through 2021.