OBJECTIVES: Multiple myeloma (MM) is one of the most prevalent hematological malignancies globally, and is associated with substantial morbidity and mortality. A randomized controlled trial of a novel integrated e-coach in the MM care-pathway, consisting of 8 modules, was developed and implemented for multiple myeloma patients. Self-reported outcomes will be monitored during the ITUMM-trial and are available 24/7. A diverse target group (age, language, technical comprehension) with possible effect of the intervention on life expectancy.ClinicalTrials.gov number: NCT05964270 and ABR number: NL75771.075.20.

METHODS: A two-arm open-label parallel-group (n=150) randomized controlled trial was conducted between March 2021 and June 2024 to compare the telemonitoring (MM e-coach) with standard MM care. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: GFI, EQ-5D-5L, EORTC-QLQ-C30, SDM-Q-9, MARS-5, single item questions, PREMs, adverse events, OS and PFS. Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.

RESULTS: In this interim study, results are categorized into patient perspective, healthcare provider perspective, and secondary endpoints. Both patients and providers report satisfaction with the e-coach, value the medication module, and emphasize the necessity of EHR-e-coach integration for standard care. Secondary endpoints show high patient adherence (MARS-5 score of 23), improved EORTC-QLQ-C30 scores (from 59 to 83), and high SDM-Q9 scores (39 and 43). The frequency of phone calls has decreased, with patients sending an average of 15 messages per year (range: 3-62). There are also fewer prolonged hospitalizations.

CONCLUSIONS: This study demonstrates the positive effects of intensive, personalized care for patients immediately following a diagnosis MM.