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.
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.
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.
- Conditions
- Hematological Diseases
- 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.
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.
- First posted13 Sep 2021
- Study start15 Sep 2021
- Primary completion16 Jun 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05041933
- Acronym / sponsor ID
- Carfil-HAD / 87RI20_0054
- Conditions
- Hematological Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with relapsed or refractory multiple myeloma (having received at least one previous treatment),
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- Inability to understand the protocol or complete the questionnaires.
- Refusing to complete the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outsourcing of chemotherapy to Hospital at Homeoutsourcing of chemotherapy to Hospital at Home | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.