Prospective Evaluation of Subcutaneous Administration of Daratumumab by the FreedomEDGE® Infusion System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Delivery Success Rate of Device-Assisted Subcutaneous Daratumumab Administration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and over
- •Having a diagnosis of multiple myeloma or light chain amyloidosis
- •Whose daratumumab is prescribed SC
- •Whose treatment with daratumumab takes place in a day hospital
- •Whose treatment with daratumumab is in the monthly injection period
- •Whose treatment with daratumumab has been carried out manually until now
- •Having signed consent to participate in the study
排除标准
- •Having known allergies to the metals of the infusion set (stainless steel)
- •Presenting bleeding disorders
- •Pregnant or breastfeeding women
- •Persons placed under guardianship, curatorship or under judicial protection;
- •Persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;
- •Persons who are not affiliated to a social security scheme or beneficiaries of such a scheme.
- •Subject participating in another interventional research including an exclusion period still in progress at pre-inclusion and which may interfere with the present study according to the judgment of the investigator
结局指标
主要结局
Delivery Success Rate of Device-Assisted Subcutaneous Daratumumab Administration
时间窗: Month 1, at the end of the procedure
Performance will be assessed by the proportion of system-assisted subcutaneous administrations achieving complete delivery (100%) of the prescribed 15 mL dose without device-related malfunction or unplanned manual intervention (delivery success).
次要结局
- Type of malfunctions occuring(Month 1, at the end of the procedure)
- Subcutaneous Daratumumab Administration Duration (minutes)(Month 1, at the end of the procedure)
- Number of malfunction occuring(Month 1, at the end of the procedure)
- Recourse methods in case of malfunction(Month 1, at the end of the procedure)
- Skin or systemic events(within 5 minutes of end of administration)
- Number of reactions(within 5 minutes of end of administration)
- Type of reactions(within 5 minutes of end of administration)
- Grade of reactions(within 5 minutes of end of administration)
- Accountability of adverse reaction(Month 1, at the end of the procedure)
- Nurses Pain scale(within 5 minutes of end of administration)
- Nurses repetitiveness felt(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses ease of installation and connection felt(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses ease of injection felt(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses system reliability felt(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses perception of patient comfort(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses overall satisfaction(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Nurses preference system(Month 1, at the end of the day, post-use of the infusion system for each nurse)
- Patients feeling about comfort(5 minutes after completion of injection)
- Patients global satisfaction(5 minutes after completion of injection)
- Patients preference(5 minutes after completion of injection)