Subcutaneous Daratumumab at Home Is a Safe and Effective Procedure for Frail Patients with Multiple Myeloma: A Myelhome Project Report
Gioia De Angelis, Alessia Fiorini, Giulio Trapè, Valentina Panichi, Maria Gabriela Chavez, Elisa Emanueli Cippitelli, Vincenza Innocenti, Roberta Perazzini, Roberta Talucci, Giuseppe Topini, Ambra Di Veroli, Caterina Mercanti, Fiammetta Natalino, Michela Tarnani, Marco Morucci, Cristina Mastini, Assunta Silvestri, Alessandro Andriani, Marco Montanaro, Silvia Ciambella, Roberto Latagliata- Cell Biology
- Hematology
- Immunology
- Biochemistry
Background Treatment of Multiple Myeloma (MM) is often difficult due to patient (pts) frailty, bone lesions/fractures that can hinder transport and/or long distance from the hospital. The availability in the Viterbo province of a Domiciliary Hematologic Care Unit (DHCU) allowed to overcome these difficulties.
Patients and methods Herein, the experience in 15 patients with MM treated as outpatients [10 at home (HC) and 5 in a Long Term Residential Accomodation (LTRA)] with subcutaneous (sc) daratumumab (dara) is reported, as part of the Myel-Home project. The initial 2 dara administrations, either intravenous or sc, were given in hospital to prevent side effects, while subsequent administrations were done as outpatients: the first dara administration as outpatient was done by nurse and physician, while subsequent ones by nurse only.
Results: The main clinical features of pts at baseline of dara initiation are shown in the Table. Different reasons for outpatient management were: advanced age (> 80 years) in 3 pts, illness related symptoms in 8 pts, social conditions and/or long distance in 4 pts. Distance from DHCU to pts home was < 20 Km in 4 cases ( 27%), ≥ 20 < 40 Km in 10 (66%) and ≥ 40 Km in 1 (7%). Different lines of treatment and different schemes are reported in the Table: among 7 pts treated in 1 st line, 3 were transplant eligible and 4 transplant ineligible. On the whole, 110 administrations of sc-dara were performed by DHCU nurses as outpatient: during and/or immediately after home administration, only one pt had adverse events (grade 2 allergic reaction according WHO), leading to dara permanent discontinuation after the 2nd dose at home. Main adverse events during the course of domiciliary treatment were infections (pneumonia in 4 pts, sepsis in 2, cystitis in 1) and deep vein thrombosis in 1 pts. Moreover, 4/5 patients (80%) in LTRA had infections (which were fatal in 3 of them) compared to 3/10 pts (30%) in HC with only 1 related death. Two pts were not yet evaluable for response and one pt discontinued early: among the evaluable 12 pts, 1 achieved a stringent complete remission and 4 a very good partial remission, with an overall response rate of 42%, 5 pts had a stable disease and 2 pts a disease progression. At the last follow-up, 8 pts are alive (2 waiting for transplant procedure) and 7 pts died (3 from disease progression, 3 from infective complications and 1 from heart disease).
Conclusions: Treatment at home with sc-dara in frail pts with MM is feasible and safe with improved quality of life, making possible a curative approach frontline as well as in advanced phases of disease also in subjects otherwise excluded by best available therapies or forced to long periods of hospitalization: it is worth of note that pts living in LTRA were at high risk of infective complications, thus limiting the advantages of a domiciliary management compared to pts living at our own house. In the next future, within the Myel-Home project, other monoclonal antibodies (belantamab-mafodotin and talquetamab) will be available for home administration.