Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05620238 |
| Other study ID # |
Home Carfi |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Odense University Hospital |
| Contact |
Jannie Kirkegaard, RN |
| Phone |
+45 29648494 |
| Email |
jannie.kirkegaard[@]rsyd.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
New treatment regimens with increased efficiency and reduced toxicities are being introduced
in the treatment of Multiple Myeloma (MM). As a result, patients can expect increased
survival, but also increased time on active treatment. Consequently, patients spend an
increasing amount of time at the hospital and on transportation. This may not only expose the
patients to unnecessary risks of infections, but will also reduce their available time to
have a meaningful life. Carfilzomib is a drug used alone or in combination with other drugs
for treatment of relapsed multiple myeloma. It is gives as an intravenous infusion day 1 and
2, day 8 and 9, and day 15 and 16 every 28th day. Thus, the patients have to show up at the
hospital many times with the risk of acquiring infections. Likewise they sometimes live a
long way from the hospital, and therefore spent a lot of time on transportation to and from
treatment.
The investigator wish to minimize the number of times the patients have to go to the
hospital, by educating them to self-administer day 2, 9 and 16 in their own home. The
investigator hope thereby to reduce their risk of hospital-acquired infections and to reduce
the time spent on transportation to and from treatment. From a hospital point of view the
investigator hope it will reduce the pressure on space in the outpatient clinic; that it will
reduce the time a nurse spent on treatment.
In the present project, intravenous Carfilzomib is administered in the hospital through a
peripheral intravenous needle on day 1, 8, and 15 of a 28-day cycle and the treatment for the
day after is handed to the patient in a cooling compartment. The next day the patient will
load the Carfilzomib into the pump and attach it to the peripheral intravenous needle. Once
the infusion if finished, the patient will remove the needle and the following week, bring
the cooling compartment and the pump back to the hospital.
Description:
New treatment regimens with increased efficiency and reduced toxicities are being introduced
in the treatment of Multiple Myeloma (MM). As a result, patients can expect increased
survival, but also increased time on active treatment. Consequently, patients spend an
increasing amount of time at the hospital and on transportation. This may not only expose the
patients to unnecessary risks of infections, but will also reduce their available time to
have a meaningful life. Carfilzomib is a drug used alone or in combination with other drugs
for treatment of relapsed multiple myeloma. It is gives as an intravenous infusion day 1 and
2, day 8 and 9, and day 15 and 16 every 28th day. Thus, the patients have to show up at the
hospital many times with the risk of acquiring infections. Likewise they sometimes live a
long way from the hospital, and therefore spent a lot of time on transportation to and from
treatment.
The investigator wish to minimize the number of times the patients have to go to the
hospital, by educating them to self-administer day 2, 9 and 16 in their own home. The
investigator hope thereby to reduce their risk of hospital-acquired infections and to reduce
the time spent on transportation to and from treatment. From a hospital point of view the
investigator hope it will reduce the pressure on space in the outpatient clinic; that it will
reduce the time a nurse spent on treatment.
In the present project, intravenous Carfilzomib is administered in the hospital through a
peripheral intravenous needle on day 1, 8, and 15 of a 28-day cycle and the treatment for the
day after is handed to the patient in a cooling compartment. The next day the patient will
load the Carfilzomib into the pump and attach it to the peripheral intravenous needle. Once
the infusion if finished, the patient will remove the needle and the following week, bring
the cooling compartment and the pump back to the hospital.
Data concerning number of hospital visits, time spend on medication administration, and
transportation time will be collected from all 12 patients during cycle 3-4. The investigator
will also registered if the patients starts home treatment during cycle 2. In addition, to
further explore the patients and the health care professionals' experiences with home
treatment, a semi-structured interviews with the first five patients and possibly their
relatives, will be conducted once they have received at least 4 cycles. In addition, one
focus group interview of the healthcare professionals involved will be conducted once the
project have included and treated all 12 patients.
Quantitative data will be presented as counts and percentages for categorical data and as
mean and standard deviation or median and interquartile for continuous data. The qualitative
data will be analyzed via the method of condensation, in which the essence of the meanings of
the interviewees' statements is summarized and subdivided into themes and thereafter into
descriptive statements, so that the data is systematically reviewed and divided, and is then
able to form the basis for analysis
