Carfil-HAD Pilote Study: Secure Outsourcing in Hospitalization at Home (HAH) of Carfilzomib in the Treatment of Multiple Myeloma and Validation of the Organization of the Care Model for Short-Duration Intravenous Chemotherapy at Home
Authors: Touati Mohamed , Villesuzanne Camille , Maillan Gaelle , Dmytruk Natalia , Streitcher Caroline , Brillat Catherine , Bompart Frederica , Tisseuil Chantal , Sardin Sophie , Girault Stephane , Lamarsalle Ludovic , Roussel Murielle , Moreau Stéphane 
Published: December 2024

Introduction: Since 2009 the Limoges University Hospital set up a territorial system for outsourcing the home administration of injectable chemotherapies by subcutaneous route (SC). This scheme involves 4 Hospital at home structures spread across the 3 departments of the Limousin area (Creuse, Corrèze and Haute-Vienne). In this organizational model, chemotherapies prepared in hospital pharmacies are entrusted to the HAH structures, who administer them by a nurse at patient's home. Over 20 000 chemotherapy sessions, mainly bortezomib and azacytidine, administered by SC route, were carried out during the first 10 years for more than 600 patients.

Aim: With the availability of intravenous (IV) new chemotherapies, we have performed the Carfil-HAD clinical trial since September 2021 to assess the feasibility of home administration of anti-cancer molecules by short infusion in less than 30 minutes, adapted to home administration. This is based on the existing secure model for SC chemotherapy. Carfilzomib indicated in multiple myeloma treatment, was chosen as a model within a care organization combining day hospital (OH) and HAH following standard operating procedures enabling its safe IV administration at home.

Method: This prospective clinical study involved 2 hospital departments (Limoges University Hospital and Brive Hospital) and 3 out of 4 active HAH structures. Limoges University Hospital was the promotor. The characteristics of Carfil-HAD are published on the ClinicalTrial.gov website under NCT05041933 number. Primary objective of the study is to assess the feasibility of carfilzomib administration in HAH (by evaluating the procedure's deviations (minor, major or serious). The types of deviation may be linked to the interaction between OH/HAH, with the pharmacy, the transport, the HAH structure, the waste management, the reporting of adverse events or other. Secondary objectives were 1) percentage and reasons for unscheduled re hospitalization, 2) quality of life assessment, 3) satisfaction survey, 4) medico-economic study (combined OH/HAH versus exclusive OH). Number of patients targeded: 15 to 20. Number of cycles per patient: 3. Number of carfilzomib infusions at home: 50 to 100. Set up: September 2021. Start of inclusions: December 2021. Inclusion period duration: 18 months. An amendment to the study was made in November 2022 for opening the additional inclusion center (Brive Hospital).

Results: The number of patients (pts) included 17 (10 from Limoges University Hospital and 7 from Brive Hospital). The number of carfilzomib infusions performed at patient's home was 88. Care structures: HAH of Relais Santé in Brive = 9 pts; HAH of Limoges University Hospital = 6 pts; HAH of Santé Service Limousin = 2 pts. The M/F sex ratio was 12,5. Median age was 69 years old (49-87). Regimens including carfilzomib were as follows Kd (Carfilzomib-dexamethasone): 5; KRd (Carfilzomib-Lenalidomide-dexamethasone): 2; KPd (Carfilzomib-Pomalidomide-dexamethasone): 5; DKd (Daratumumab-Carfilzomib-dexamethasone): 5. Results analysis are now avalible for the primary objective and showed no major or serious deviations related to the organization of care described in this study. During the 3 combined cycles (OH/HAH) of the study in the 15 evaluable pts, corresponding to 88 infusions performed at home, protocol deviations were observed in 6 pts (40%), 4 pts (30.8%) and only 3 pts (23.1%) during the 1st, 2nd and 3rd combined cycle respectively. All those deviations were minors. Secondary objectives results analysis are in progress.

Conclusion: The Carfil-HAD prospective study demonstrated the feasibility of IV administration of carfilzomib in the form of short duration infusions at patient's home. Standard operating procedures, developed to secure the outsourcing of carfilzomib, can be applied to any other anti-cancer molecules administered intravenously with the same infusion durations. The analysis of the results of quality of life, patient's satisfaction, reasons for unplanned re hospitalizations and medico-economic impact are in progress. We expect that Carfil-HAD study will demonstrate that this organization of care, integrating the HAH, will make it possible to make savings for health insurance funds, while improving patient's satisfaction and maintaining an optimal level of safety of care at home.