European journal of haematology · 2026
Patient and Healthcare Provider Satisfaction With Subcutaneous Versus Intravenous Administration of Daratumumab in Combination With Lenalidomide and Dexamethasone as First-Line Treatment in Patients With Newly Diagnosed Non-Transplant Eligible Multiple Myeloma: Final Results of the MYLENE Study.
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von der Heyde Eyck, Reiser Marcel, Baumgartner Vanessa, Englisch Christian, Frank Oliver, Buchholz Sabrina, Kreimendahl Fabian, Uhlig Jens, Bürkle Dieter, Knauf Wolfgang
Аннотация
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.
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.