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Hematological DiseasesCarfil-HADNCT05041933

Secure Outsourcing of Carfilzomib in the Treatment of Multiple Myeloma to the Hospital at Home Setting

An observational study of Hematological Diseases, run by University Hospital, Limoges at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Since 2009, the Department of Clinical Haematology at Limoges University Hospital Centre, supported by the HEMATOLIM network, has been operating the regional "ESCADHEM" system: [Secure outsourcing of injectable chemotherapy to the home care setting for malignant blood diseases]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Diseases
What is being tested?
outsourcing of chemotherapy to Hospital at Home
How many people
17 participants
Where
1 siteFrance
Study dates
15 Sep 2021to 1 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patient with relapsed or refractory multiple myeloma (having received at least one previous treatment),

Who may be able to join

  • Subjects aged 18 years or over.
  • Eligible for care by one of the four HAH structures in accordance with HAS criteria,
  • With relapsed or refractory multiple myeloma (having received at least one previous treatment),
  • Whose case has been examined at multidisciplinary team (MDT) meetings at Limoges University Hospital Centre,
  • Receiving carfilzomib parenteral chemotherapy outsourced to an HAH setting (all patients receive the entire first cycle of carfilzomib and the 1st day of each of the subsequent cycles in an outpatient clinic).
  • Having read the information leaflet concerning the Carfil-HAD study,
  • Not objecting to the use of their data in the context of this study.

Who cannot join

  • Inability to understand the protocol or complete the questionnaires.
  • Refusing to complete the questionnaires.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Limoges Hospital

    Limoges, 87 042

Other trials in France

About this study

Official title: Pilot Study: Secure Outsourcing of Carfilzomib in the Treatment of Multiple Myeloma to the Hospital at Home (HAH) Setting. Care Organisation Model for New Short Intravenous Infusion Chemotherapies

Since 2009, the Department of Clinical Haematology at Limoges University Hospital Centre, supported by the HEMATOLIM network, has been operating the regional "ESCADHEM" system: [Secure outsourcing of injectable chemotherapy to the home care setting for malignant blood diseases]. In addition to Limoges University Hospital, Brive Hospital and Guéret Hospital, this system involves four Hospital at Home (HAH) structures across the three départements of the former Limousin region.

In this process, chemotherapy administered by subcutaneous injection is prescribed by a hospital physician in one of the hospitals "authorised to deliver cancer treatments" in the former region of Limousin: Limoges University Hospital Centre, Brive Hospital or Guéret Hospital. This chemotherapy is then prepared in one of the three hospital pharmacies authorised to perform centralised reconstitution, in accordance with current standards. The preparation is then transferred to one of the four Hospital at Home (HAH) structures, which transports the product to the patient's home where it is administered by the nurse (IDE). This last step in the process is under the responsibility of the HAH structure coordinating physician, who is also responsible for waste collection.

Read more

Supported by its experience within the ESCADHEM system with subcutaneous drugs and in the context of the arrival of new intravenous drugs, in short infusion form, the Department of Clinical Haematology, supported by the HEMATOLIM network (which became the HEMATOLIM association on 1 January 2020) and the professionals involved began the process of outsourcing these drugs to the HAH setting. One of these drugs is carfilzomib, used to treat multiple myeloma, and its outsourcing to the HAH setting was put in place from the end of 2018.

In parallel with this, the Department of Clinical Haematology would like to set up a study to evaluate the feasibility of outsourcing this new drug, administered intravenously, based on a model that we know to be operational and secure for chemotherapies administered by subcutaneous injection.

the Department of Clinical Haematology hope to be able to confirm the value of caring for multiple myeloma patients in an HAH setting by improving their quality of life and optimising their care pathway in organisational and economic terms. the Department of Clinical Haematology hope to be able to demonstrate that this organisation is not only efficient in the view of patients, but also for the healthcare professionals working in the Hospital, the HAH structure and in the community, involved throughout the care process.

To conduct our study, the Department of Clinical Haematology selected the novel drug carfilzomib, used in the treatment of multiple myeloma.

The prescribing conditions, treatment administration regimen and outsourcing quality processes for this drug are available in the annexes. These standard regimens were constructed on the basis of the protocols in the ESCADHEM system, extensively trialled and validated by the HAS, for drugs injected subcutaneously and following a collegial approach. We thus hope to demonstrate that the protocols used for drugs administered by subcutaneous injection - in particular, bortezomib and azacytidine - are applicable to carfilzomib following minor modifications to the procedures given the IV administration of the latter drug as a short infusion.

It should be noted that it is essential that the first cycle of carfilzomib be administered, in its entirety, in an outpatient clinic setting. Thereafter, if the patient is eligible for treatment in an HAH setting, the 1st day of each cycle will be performed in an outpatient clinic.

Following this study, the Department of Clinical Haematology hope to be able to publish our research and promote it at national and/or international congresses. This research should further reinforce our already significant experience in this type of care strategy for malignant blood diseases in the HAH setting, which we believe is simultaneously innovative, practical and beneficial for all the players in the care pathway concerned. The model will probably be useful for outsourcing to the HAH setting other novel drugs progressively arriving on the market with profiles similar to that of the drug we wish to study.

Finally, our project aims to demonstrate that our procedures for the secure outsourcing of carfilzomib to the HAH setting, in place since the end of 2018 are valid and could be extended to other regions of France. Furthermore, the current health landscape is undergoing profound changes associated with budget constraints, as well as societal and technological evolutions, with the result that home care, and hence HAH structures, appear, more than ever, to be the model of the future.

Being tested
outsourcing of chemotherapy to Hospital at Home
Medical subject headings
Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • outsourcing of chemotherapy to Hospital at HomeDrug

    outsourcing of chemotherapy to Hospital at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of deviations from SOPs occurring in the context of secure outsourcing of carfilzomib administered by short IV infusion, for 3 cycles, to a mixed outpatient clinic/HAH care setting.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completion16 Jun 2023
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041933
Sponsor's protocol ID
87RI20_0054
Acronym
Carfil-HAD
Status last verified
Jun 2026
First submitted
3 Sep 2021
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hematological Diseases, run by University Hospital, Limoges at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of deviations from SOPs occurring in the context of secure outsourcing of carfilzomib administered by short IV infusion, for 3 cycles, to a mixed outpatient clinic/HAH care setting. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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