Prospective Evaluation of Subcutaneous Administration of Daratumumab by the FreedomEDGE® Infusion System

Multiple Myeloma or Amyloidosis

Multiple myeloma, amyloidosis, Daratumumab, Subcutaneous administration, Drug delivery device, Mechanical infusion system, FreedomEDGE®, Infusion pump, Clinical research, Medical device evaluation, Patient experience, Patient satisfaction, Nursing practice, Healthcare professionals, Treatment administration, Injection comfort, Device performance, Adverse events, Feasibility study

This study is evaluating a new method for administering daratumumab, a treatment commonly used in the management of multiple myeloma and amyloidosis. For several years, this treatment has been administered by subcutaneous injection in just a few minutes, significantly reducing the amount of time patients spend in hospital. Currently, this injection is performed manually by nurses. Although effective, this method may be demanding in daily practice due to the repetitive nature of the procedure and the physical workload involved for healthcare professionals. The aim of this study is to evaluate a medical device called FreedomEDGE®, developed by KORU Medical Systems, which enables mechanical and automated subcutaneous administration of daratumumab. This device operates without electricity: a spring-based system applies constant pressure to a syringe in order to deliver the medication steadily through a subcutaneous needle. This type of equipment is already used for the administration of other subcutaneous treatments, like immunoglobulins. The primary objective of the study is to assess whether this device enables safe and effective administration of the treatment. Secondary objectives include evaluating administration time, identifying potential technical malfunctions, describing the occurrence of local or systemic adverse events, and assessing the experience and satisfaction of both patients and nurses using the device. For patients, the expected benefits include more consistent and controlled administration, potential improvement in injection comfort, and a smoother care experience. For healthcare professionals, this approach may help to reduce the burden associated with repeated injections, improve working conditions, and support more efficient organisation of care in the day hospital setting. This study will be conducted in the daily hospitalisation unit of the Clinical Hematology Department at Lyon Sud Hospital and will include approximately 100 patients with multiple myeloma or amyloidosis receiving subcutaneous daratumumab. Participation is fully integrated into routine care. Patients who agree to participate will sign an informed consent form before any study-specific procedures are carried out. The treatment administered will remain exactly the same as that planned as part of routine care; only the method of administration will change, with one injection being delivered using the FreedomEDGE® device. An additional clinical assessment will be performed before administration to confirm that there are no contraindications to injection. After administration, patients will be asked to complete a short questionnaire regarding their experience and satisfaction, and nurses will also complete a questionnaire about their experience using the device. No additional blood samples, no additional medication, and no specific restrictions regarding usual treatments are planned as part of this study. Participation will end after the visit corresponding to the injection performed using the device. At any time, the investigator may discontinue participation if considered necessary for patient safety or in the patient's medical interest.

This clinical investigation is designed to generate clinical evidence supporting evaluation of the performance and safety of the FreedomEDGE® Infusion System for subcutaneous (SC) administration of daratumumab. Daratumumab is a human IgG1κ monoclonal antibody directed against CD38 and approved for the treatment of multiple myeloma. The availability of a subcutaneous formulation has substantially reduced administration time compared with intravenous infusion while maintaining therapeutic effectiveness and improving treatment convenience. The approved SC formulation is administered continuously over approximately 3-5 minutes. In routine clinical practice, SC administration of daratumumab requires nurses to manually apply continuous pressure to the syringe plunger throughout the injection period in order to maintain administration conditions consistent with the approved product labelling. This manual procedure may introduce variability in injection duration and administration consistency and may contribute to patient discomfort, local injection-site reactions, and repetitive physical strain for healthcare professionals. The FreedomEDGE® Infusion System is a mechanical, non-electrical infusion device intended for controlled subcutaneous administration of medicinal products. The system combines a reusable infusion pump with sterile precision flow tubing and sterile High-Flo™ SubQ needle sets. Drug delivery is achieved through a constant-force spring mechanism associated with dedicated flow restriction tubing selected according to product viscosity and administration conditions. Although the device currently bears CE marking for selected approved subcutaneous therapies, administration of daratumumab is not currently included within its intended purpose. This clinical investigation is conducted within the framework of Regulation (EU) 2017/745 on medical devices (MDR) as a clinical investigation intended to establish conformity of a CE-marked device used outside its currently approved intended purpose, with the objective of supporting extension of CE marking. According to applicable European and national regulatory classification criteria, this investigation corresponds to regulatory category 1. This is a prospective, single-centre, non-randomized clinical investigation conducted in the Clinical Hematology Department of Lyon-Sud hospital (Pierre-Bénite, France). The primary objective is to evaluate the performance of the FreedomEDGE® Infusion System for subcutaneous administration of daratumumab. Device performance is defined as the ability to provide reliable, controlled, and complete administration of the prescribed dose under normal conditions of use and according to the device instructions for use. Eligible participants must be adults, diagnosed of multiple myeloma or light-chain amyloidosis; treated with monthly subcutaneous daratumumab. Participants are recruited among patients routinely followed in the Clinical Hematology Department and receiving daratumumab in the day hospital setting. Enrolment occurs once treatment reaches the monthly administration phase, corresponding to patients who have already received several prior manual SC injections and therefore have prior experience with standard administration. Approximately 100 evaluable administrations are planned. Based on expected routine activity and patient flow, recruitment is expected to be completed over approximately six months. At Screening and Inclusion time (T0), potential participants are identified during routine follow-up within the hematology department. Patients whose daratumumab schedule reaches monthly administration are informed about the study by a physician co-investigator. Patients receive oral and written information describing study objectives, procedures, constraints, potential risks, safety measures, and participant rights, including the right to refuse participation or withdraw consent at any time without impact on standard care. Written informed consent is obtained before any study-specific procedure. Eligibility criteria are subsequently verified in full before formal enrolment. Clinical evaluation at inclusion is limited to routine assessment and observation of the future injection site. The study intervention is performed at the participant's next scheduled monthly administration visit (M1). Subcutaneous daratumumab is administered using the FreedomEDGE® Infusion System according to the device instructions for use and following nurse training. Administration is performed using a prefilled daratumumab syringe connected to dedicated precision flow tubing (reference F1200) and a sterile High-Flo™ SubQ needle set (24G, 9 mm). After skin preparation and placement of the needle, the syringe is loaded into the device and administration is initiated. Following administration, the following data are collected: device traceability information; administration duration; total injected volume compared with prescribed volume; occurrence and description of any device malfunction; corrective actions implemented to complete administration if required; occurrence of local skin reactions; occurrence of systemic adverse events. Following administration, nurses complete a study-specific questionnaire assessing: pain associated with administration; ease of use; ease of injection; device reliability; overall satisfaction; preference between manual administration and device-assisted administration; interest in extending use of the system to other therapies. Patients complete a study-specific questionnaire assessing: injection experience; comfort; satisfaction; preference between manual administration and device-assisted administration. Questionnaires are completed shortly after administration and require approximately five minutes. The end-of-study visit corresponds to the M1 administration visit. Participant follow-up ends after completion of this visit. No biological samples are collected specifically for study purposes. No additional visits, laboratory tests, imaging procedures, or invasive assessments are required beyond standard care. Expected benefits for patients include more standardized and controlled administration, improved injection comfort, and reduction of injection-related discomfort. Expected benefits for healthcare professionals include reduced physical strain associated with repeated manual injections and improved working conditions. Risks associated with device use are expected to remain comparable to routine subcutaneous administration and include administration error, contamination, injection-site trauma, and local reactions such as redness, swelling, or pain. Appropriate monitoring and risk mitigation procedures are implemented throughout the study. In case of device malfunction, administration may be completed manually according to standard practice. Overall, considering the anticipated improvements in administration standardization and user experience together with the limited and controlled risks associated with the procedure, the expected benefit-risk profile is considered favourable.

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