Home Treatment With Carfilzomib in Patients With Multiple Myeloma

NCT ID: NCT05620238

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2026-06-01

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Carfilzomib

Investigate the home administration of Carfilzomib IV reported by both patients and health care staff compared to the hospital setting.

Intervention Type: DRUG

Other Intervention Names

Kyprolis

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients receiving trial medication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Lund

OTHER

Sponsor Role: lead

Responsible Party

Thomas Lund

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nana Hyldig, PhD, RN

Role: STUDY_CHAIR

Odense University Hospital

Locations

Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jannie Kirkegaard, RN

Role: CONTACT

jannie.kirkegaard@rsyd.dk

+45 29648494

Facility Contacts

Jannie Kirkegaard, RN

Role: primary

Jannie.kirkegaar@rsyd.dk

+45 29648494

Other Identifiers

Home Carfi

Identifier Type: -

Identifier Source: org_study_id