Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.

NCT05306587 | Completed DMC FDA Drug

• 1 other identifier: DAPHNE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple myeloma (MM) is the second most common hematological disease in Denmark with an incidence of approximately 350 diagnosed cases per year. There is no curative treatment yet, but usually the disease is very sensitive to treatment, and patients have periods of varying length, where they do not require treatment. Thus the prognosis for MM has improved over recent years, and the rate of survival has been extended for both younger and elderly patients. With the increasing specialization and centralization that will occur in the coming years, some patients will have very long transport times to the hospital. When patients go to the hospital only to receive their anticancer therapy, their visits are relatively short and the amount of time spend on transportation might appear disproportionate. The frequent hospital appointments increase the patient's exposure for bacteria and viruses which should be calculated as a potential risk. Furthermore if the patient is an active part of the labor market, it can be challenging to request freedom to hospital visits. It is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy it is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy. The aim of this project is to investigate the home administration of Daratumumab SC reported by both patients and healthcare professionals compared to the hospital administration setting. Furthermore, this project investigates the hypothesis that the home administration of Daratumumab potentially can reduce the time associated with the administration, thereby, resulting in a socio-economic gain. The aim for this study: We want to examine patients 'and healthcare professionals' perspectives, the organizational and the socio economic aspects of administering subcutaneous Daratumumab in their own home to patients with multiple myeloma, and to illuminate the benefits and challenges of this.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Patients' satisfaction reported by semi-structured interviews and patient reported outcome measurements (PROM)

  To analyse changes in QoL measured by EORTC IL90

  01.04.2022-01.08.2024

Secondary Outcomes (4)

• Examination of patients' time spend on treatment in minutes

  01.04.2022-01.08.2024

• Examination of healthcare professionals' time spend on treatment in minutes

  01.04.2022-01.08.2024

• Examination of healthcare professionals' satisfaction using focus group interview

  01.04.2022-01.08.2024

• Examination of financial perspective through calculations healthcare salaries based on time spend on treatment and transportation of medicatoin and/or patients

  01.04.2022-01.08.2024

Study Arms (1)

Multiple Myeloma

40 patients with Multiple Myeloma in Department of Hematology at Odense University Hospital, Denmark

Drug: Darzalex

Interventions

Darzalex DRUG

Investigate the home administration of Darzalex SC reported by both patients and healthcare professionals compared to the hospital administration setting.

Also known as: Daratumumab

Multiple Myeloma

Eligibility Criteria

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

Study Population

40 patients planned to start treatment with SC Darzalex or patients allready in treatment with SC Darzalex.

You may qualify if:

• have relapse of MM.
• be in or have planned to start treatment with Daratumumab SC.
• be cognitively capable to assess any side effects of Daratumumab SC based on the instructions provided.
• be able and willing to register in a timetable and to participate in two semi-structured telephone interviews.
• be able to understand and speak Danish.
• be in possession of a mobile phone (for SMS tracking).

You may not qualify if:

• \- receive other anti-myeloma treatment that require hospitalization with the exception of visit 1 in all cycles with Daratumumab SC administration.

Sponsors & Collaborators

• Thomas Lund: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Rosenberg T, Kirkegaard J, Gundesen MT, Rasmussen MK, Dieperink KB, Lund T. Home-Based Daratumumab in Patients With Multiple Myeloma. Eur J Haematol. 2025 Jul;115(1):72-81. doi: 10.1111/ejh.14409. Epub 2025 Mar 31.

  PMID: 40165411 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

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

• Karin Dieperink, RN, PhD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: April 1, 2022
• Study Start: April 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)