Multiple MyelomaNCT05620238
Home Treatment With Carfilzomib in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Thomas Lund at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Carfilzomib
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2022to 1 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Multople Myeloma in treatment with IV Carfilzomib
Who may be able to join
- Patients diagnosed with Multiple Myeloma in treatment with Carfilzomib
- Patients must have received a minimum of one treatment cycle in the outpatient clinic
- Patients must understand and speak Danish
Who cannot join
- Patients receiving trial medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical, Mixed-method Study Exploring Patient and Health Care Perspectives
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.
Read the detailed 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
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
Also called Kyprolis
Investigate the home administration of Carfilzomib IV reported by both patients and health care staff compared to the hospital setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients satisfaction
Patients satisfaction reported by semi-structured interviews and Pro-data regarding prefered treatment method
Measured: 15.12.2022-01.04.2024
Secondary outcomes (1)
Examination of patients and health care staffs time spent on treatment
Examination of patients and health care staffs time spent on treatment in minutes on paper
Measured: 15.12.2022-01.04.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Dec 2022
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Lund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Lund, Odense University Hospital
- Investigators
- Nana Hyldig, PhD, RN, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620238
- Sponsor's protocol ID
- Home Carfi
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical, Mixed-method Study Exploring Patient and Health Care Perspectives
- ClinicalTrials.gov ID
- NCT05620238
- Acronym / sponsor ID
- Home Carfi
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thomas LundUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 17 Nov 2022 (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.
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.
Detailed 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multople Myeloma in treatment with IV Carfilzomib
Key inclusion criteria (3 listed)
- Patients diagnosed with Multiple Myeloma in treatment with Carfilzomib
- Patients must have received a minimum of one treatment cycle in the outpatient clinic
- Patients must understand and speak Danish
Key exclusion criteria (1 listed)
- Patients receiving trial medication
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 |
|---|---|---|
| CarfilzomibAlso: KyprolisInvestigate the home administration of Carfilzomib IV reported by both patients and health care staff compared to the hospital setting. | Drug | – |
Primary outcome
Patients satisfaction
Time frame: 15.12.2022-01.04.2024
Patients satisfaction reported by semi-structured interviews and Pro-data regarding prefered treatment method
1 secondary outcome
Examination of patients and health care staffs time spent on treatment
Time frame: 15.12.2022-01.04.2024
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 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Nana Hyldig, PhD, RN study chair
Odense University Hospital
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 Multiple Myeloma, run by Thomas Lund at 1 site in Denmark.
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 3 inclusion and 1 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 10 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 Denmark. 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?
Patients satisfaction (time frame: 15.12.2022-01.04.2024). 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 10 Jun 2026.