Clinical 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]. 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.
