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

NCT07721350 | Not Yet Recruiting

• 2 other identifiers: 69HCL26_00942026-A01304-47
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma or Amyloidosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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

• Type of malfunctions 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

Study Arms (1)

FreedomEDGE® daratumumab administration arm

EXPERIMENTAL

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®

Interventions

Subcutaneous Daratumumab Administration Using FreedomEDGE® DEVICE

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.

FreedomEDGE® daratumumab administration arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• KORU Medical Systems: collaborator

Study Sites (1)

Hôpital Lyon-Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Multiple Myeloma; Amyloidosis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Zofia GROSS, MD

  Groupement Hospitalier Sud, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zofia GROSS, MD

CONTACT

+33 4 78 86 30 71; zofia.gross@chu-lyon.fr

Magali MAIRE, PhD

CONTACT

+33 4 78 86 43 04; magali.maire@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)