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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma or Amyloidosis
• Intervention / Treatment: Device: Subcutaneous Daratumumab Administration Using FreedomEDGE®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zofia GROSS, MD; Phone Number: +33 4 78 86 30 71; Email: zofia.gross@chu-lyon.fr
• Study Contact Backup: Name: Magali MAIRE, PhD; Phone Number: +33 4 78 86 43 04; Email: magali.maire@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon-Sud
    • Contact: Zofia GROSS, MD; Phone Number: +33 4 78 86 30 71; Email: zofia.gross@chu-lyon.fr
    • Contact: Magali MAIRE, PhD; Phone Number: +33 4 78 86 43 04; Email: magali.maire@chu-lyon.fr
    • Principal Investigator: Zofia GROSS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FreedomEDGE® daratumumab administration arm; Participants will receive their planned subcutaneous daratumumab treatment as part of routine clinical care. The investigational intervention consists solely of administering daratumumab using the FreedomEDGE® mechanical infusion system instead of the standard manual nurse-administered injection. FreedomEDGE® is a non-electric infusion device that uses a spring mechanism to apply constant pressure to a syringe, enabling controlled and continuous subcutaneous delivery of the drug through a subcutaneous needle connected by tubing. Prior to administration, an additional clinical assessment will be performed to confirm the absence of contraindications. Following treatment administration, patients will complete a short questionnaire evaluating their experience and satisfaction, and nurses will complete a questionnaire regarding usability and their experience with the device.

Device: Subcutaneous Daratumumab Administration Using FreedomEDGE®; Participants will receive a single administration of subcutaneous daratumumab using the FreedomEDGE® mechanical infusion system during a routine scheduled treatment visit. The medicinal product, dose, indication, and standard clinical management remain unchanged and follow usual care. The intervention consists exclusively of replacing the standard manual nurse-administered subcutaneous injection with device-assisted administration. FreedomEDGE® is a non-electric mechanical infusion device that uses a spring-driven mechanism to apply constant pressure to a prefilled syringe, enabling controlled and continuous delivery of daratumumab through a subcutaneous needle connected by tubing. Prior to administration, a brief clinical assessment will confirm the absence of contraindications to treatment administration. No additional procedures, medications, or biological sampling are planned as part of the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery Success Rate of Device-Assisted Subcutaneous Daratumumab Administration	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).	Month 1, at the end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcutaneous Daratumumab Administration Duration (minutes)	Daratumumab injection duration (in minutes)	Month 1, at the end of the procedure
Number of malfunction occuring	Number of malfunction occurence	Month 1, at the end of the procedure
Type of malfunctions occuring	Type of malfunctions occurence	Month 1, at the end of the procedure
Recourse methods in case of malfunction	Description of recourse methods implemented to ensure that the injection is carried out in its entirety following malfunctions	Month 1, at the end of the procedure
Skin or systemic events	Occurrence of at least one skin reaction or systemic event	within 5 minutes of end of administration
Number of reactions	Number of reactions per patient	within 5 minutes of end of administration
Type of reactions	Type of reactions (at puncture point or generalized)	within 5 minutes of end of administration
Grade of reactions	Grade of reactions (according to CTCAE)	within 5 minutes of end of administration
Accountability of adverse reaction	Count of adverse reactions related to the device	Month 1, at the end of the procedure
Nurses Pain scale	Score obtained on a pain scale (VAS from 0 to 10)	within 5 minutes of end of administration
Nurses repetitiveness felt	The repetitiveness of nurse gesture (scores obtained on a scale developed by the hematology department)	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses ease of installation and connection felt	The ease of installation and connection for nurse (scores obtained on a scale developed by the hematology department)	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses ease of injection felt	The ease of injection for nurses (scores obtained on a scale developed by the hematology department)	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses system reliability felt	The system reliability felt for nurses (scores obtained on a scale developed by the hematology department)	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses perception of patient comfort	Nurses perception of patient comfort (scores obtained on a scale developed by the hematology department)	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses overall satisfaction	Score of Nurses overall satisfaction with a Lickert scale	Month 1, at the end of the day, post-use of the infusion system for each nurse
Nurses preference system	Expression of the preference of the injection system thanks to the DM compared to the classic manual method	Month 1, at the end of the day, post-use of the infusion system for each nurse
Patients feeling about comfort	Score obtained on a likert scale	5 minutes after completion of injection
Patients global satisfaction	Score obtained on a likert scale	5 minutes after completion of injection
Patients preference	Expression of the preference of the injection system using medical device compared with the manual method	5 minutes after completion of injection

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: KORU Medical Systems
• Investigators: Principal Investigator: Zofia GROSS, MD, Groupement Hospitalier Sud, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Multiple myeloma; Patient satisfaction; Daratumumab; amyloidosis; Adverse events; Feasibility study; Infusion pump; Healthcare professionals; Patient experience; Nursing practice; Clinical research; Subcutaneous administration; Drug delivery device; Mechanical infusion system; FreedomEDGE®; Medical device evaluation; Treatment administration; Injection comfort; Device performance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Proteostasis Deficiencies; Behavior; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Treatment Adherence and Compliance; Health Behavior; Multiple Myeloma; Amyloidosis; Patient Satisfaction
• Other Study ID Numbers: 69HCL26_0094; 2026-A01304-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No