Home Treatment With Carfilzomib in Patients With Multiple Myeloma

NCT05620238 | Recruiting DMC FDA Drug

• 1 other identifier: Home Carfi
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Patients satisfaction

  Patients satisfaction reported by semi-structured interviews and Pro-data regarding prefered treatment method

  15.12.2022-01.04.2024

Secondary Outcomes (1)

• Examination of patients and health care staffs time spent on treatment

  15.12.2022-01.04.2024

Interventions

Carfilzomib DRUG

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

Also known as: Kyprolis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Multople Myeloma in treatment with IV Carfilzomib

You may qualify if:

• 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

You may not qualify if:

• Patients receiving trial medication

Sponsors & Collaborators

• Thomas Lund: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nana Hyldig, PhD, RN

  Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Jannie Kirkegaard, RN

CONTACT

+45 29648494; jannie.kirkegaard@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 15, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)