Abstract / Summary
ABSTRACT Objectives The MYLENE non‐interventional study (NIS) aimed to close the gap in real‐world data on the experience and satisfaction with subcutaneous (sc) and intravenous (iv) daratumumab application in patients with newly diagnosed non‐transplant eligible multiple myeloma in Germany. The study specifically focused on satisfaction among both patients and healthcare providers (HCP). Methods MYLENE was a prospective, multicenter NIS in Germany, designed to evaluate patient and HCP satisfaction with sc and iv daratumumab administration via study‐specific, non‐standardized questionnaires, as well as patient safety data. Results Between 2022 and 2023, 108 patients were enrolled at 34 sites; 96 were included in the full analysis set (38 iv, 48 sc, 10 switchers); due to the low switcher rate, conclusions regarding this subgroup are very limited. Median age was 76 years. Patients were highly satisfied with their daratumumab treatment (median rating 9 on a 1–10 scale). Overall HCP satisfaction level was higher for sc (9) than iv (7), and HCPs reported higher satisfaction with sc administration time and patient visit duration. No new safety signals were detected. Conclusions MYLENE provides insights into the practical management of daratumumab administration in office‐based settings in Germany. Patients reported high satisfaction with both sc and iv administration. The study highlights a preference among HCPs for sc administration, primarily due to reduced time requirements. Trial Registration NCT05284591