Clinical trial · Observational
Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.
Daratumumab Provided at Home Experience: An Open, Single-center, Mixed-method Project Initiated on Behalf of Odense University Hospital
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darzalex | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Multiple Myeloma
- description
- 40 patients with Multiple Myeloma in Department of Hematology at Odense University Hospital, Denmark
- interventionNames
- Drug: Darzalex
Primary outcomes (1)
- measure
- Patients' satisfaction reported by semi-structured interviews and patient reported outcome measurements (PROM)
- timeFrame
- 01.04.2022-01.08.2024
- description
- To analyse changes in QoL measured by EORTC IL90
Secondary outcomes (4)
- measure
- Examination of patients' time spend on treatment in minutes
- timeFrame
- 01.04.2022-01.08.2024
- description
- Examination of patients' time spend on treatment in minutes through an app on a smartphone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: \- receive other anti-myeloma treatment that require hospitalization with the exception of visit 1 in all cycles with Daratumumab SC administration.
References
Publications (1)
- DERIVEDRosenberg 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