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Could a spring-powered injector make cancer drug delivery smoother for patients and nurses?

NCT ID NCT07721350

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a mechanical, spring-driven device called FreedomEDGE® can safely and effectively deliver daratumumab, a standard treatment for multiple myeloma and amyloidosis. Currently, nurses give these injections by hand, which can be physically demanding. About 100 patients will receive one injection using the device during a routine visit. The study will measure whether the full dose is delivered without problems, how long it takes, and how patients and nurses feel about the experience.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
daratumumab delivered via a spring-powered mechanical infusion system called FreedomEDGE®
What this could lead to
If successful, this device could make daratumumab injections more consistent and comfortable for patients, while easing the physical strain on nurses who give these injections repeatedly.
What could go wrong
This is a small, early-stage study focused on feasibility and safety. The device may malfunction, cause injection-site reactions, or not deliver the full dose reliably.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis Patient Satisfaction plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma or amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Lyon-Sud

    Pierre-Bénite, 69495, France

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