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

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

Interventions

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.

Sponsors & Collaborators

• KORU Medical Systems

  collaborator UNKNOWN

• Hospices Civils de Lyon

  lead OTHER

Principal Investigators

• Zofia GROSS, MD · Groupement Hospitalier Sud, Hospices Civils de Lyon

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• France

Study Locations