Subcutaneous daratumumab at home is a safe and effective procedure allowing active treatment of frail patients with multiple myeloma

Abstract Treatment of Multiple Myeloma (MM) is often difficult due to patient (pts) frailty, bone lesions/fractures that can hinder transport, lack of an available caregiver and/or long distance from the hospital. The availability of a Domiciliary Hematologic Care Unit (DHCU) could allow to overcome these difficulties, but data on safety and efficacy of this approach as concern subcutaneous (sc) administration of daratumumab (dara) are still lacking. Herein, the experience with home administration of sc dara in two hematologic Centres with a DHCU in different geographical areas (Rome and Viterbo province) is reported, as part of the Myel-Home project. The initial 2 dara administrations were given in hospital to prevent side effects, while subsequent administrations were done as outpatients. Data from 28 pts [M/F 10/18 (35.7%/64.3%), median age 76.3 years, interquartile range (IQR) 66.9 – 81.3] were collected from 9/2021 to 1/2025: [M/F 10/12 (45.5/54.5), median age 71.8 years, interquartile range (IQR) 64.3 – 78.8] The main reasons for the activation of home-care modality by responsible physician were as follows: disease complications (bone lesions/fractures secondary to MM) in 14 pts (50.0%), age > 80 years in 8 pts (28.6%), long distance from the hospital and/or poor social conditions in 6 pts (21.4%). Distance from DHCU to pts home was < 10 Km in 13 cases ( 46.4%), ≥ 10 < 30 Km in 2 (7.2%) and ≥ 30 Km in 13 (46.4%). Fifteen pts (53.6%) were in 1st line treatment, and 13 (46.4%) in 2nd or subsequent lines of treatment. Dara-based schemes were Dara-Rd in 12 pts (42.9%), Dara-VTD in 7 pts (25.0%), Dara-VMP in 5 pts (17.8%) and Dara-VD in 4 pts (14.3%). On the whole, 312 administrations of sc-dara were performed at home: during and/or immediately after home administration, only one pt (3.6%) had adverse events (grade 2 allergic reaction according WHO), leading to dara permanent discontinuation. Main adverse events during the home management were infections (pneumonia in 4 pts, FUO in 1). Three pts were not yet evaluable for response and one pt discontinued early: among the evaluable 24 pts, 4 achieved a complete remission (stringent in 2 cases), 11 a very good partial remission and 2 a partial remission, with an overall response rate of 70.8%: four pts had a stable disease and 3 pts a disease progression. Among the 7 pts in 1st line potentially eligible for transplant (age < 70 years), 4 were transplanted, 1 is in evaluation and 2 refused the procedure shifting to maintenance with lenalidomide. At the last follow-up, 18 pts are alive and 10 pts died (6 from disease progression, 2 from cardiological diseases, 1 from liver disease and 1 from evolution in acute myelogenous leukemia). Median overall survival from the start of home management was 35.3 months (95%CI 18.5 – 59.2). Treatment at home with sc-dara in frail pts with MM is feasible and safe also in different geographical settings: it makes possible a curative approach frontline and in advanced phases also in pts otherwise excluded by best available therapies or forced to long periods of hospitalization