Multiple MyelomaNCT05306587
Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.
An observational study of Multiple Myeloma, run by Thomas Lund at 1 site in Denmark.
Trial 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. 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?
- Darzalex
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 1 Jan 2024
- How long will I take part?
- 6 Months
- 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: 40 patients planned to start treatment with SC Darzalex or patients allready in treatment with SC Darzalex.
Who may be able to join
- 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).
Who cannot join
- receive other anti-myeloma treatment that require hospitalization with the exception of visit 1 in all cycles with Daratumumab SC administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daratumumab Provided at Home Experience: An Open, Single-center, Mixed-method Project Initiated on Behalf of Odense University Hospital
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.
Read the detailed description
This study is a prospective, non-randomized, clinical parallel mixed-methods intervention project using qualitative and quantitative data in the form of semi-structured telephone interviews, focus group interviews, time registration, registration of patients' contact with the healthcare system and PRO data. The project will both include patients already being treated with SC Daratumumab and new patients planned to start Daratumumab treatment = 40 patients in all. The patients will be included in the department of hematology Odense University Hospital as they are found eligible.
The intervention of the study is home administration of Daratumumab SC by a home nurse, thereby, changing the administration setting from a hospital setting to at home setting. The intervention with home administration will be compared to the hospital setting. The patients will function as their own controls, as treatment will be given alternately at the hospital.
Patients scheduled for Daratumumab SC at home will be phoned by a nurse from the Hematology Outpatient Clinic the day before planned administration. This procedure is chosen as that it allows the nurse to determine whether it is justifiable, for the patient to receive treatment at home. If the nurse and doctor assess that the patient is fit for home administration of Daratumumab SC, the drug will be ordered at the pharmacy to be delivered to the patient the following day. Also an electronic message will also be sent to the home nurses with an instruction to administer Daratumumab SC between 12-02 PM.
Data collection will consist of:
- Semi-structured virtual (or alternative telephone) interviews with participating patients focusing on benefits / gains versus challenges / disadvantages in regard to the actual injection, collaboration with the home nurse, delivery of medication, empowerment, and suggestions for further improvements n = 2 x 10
- Semi-structured interviews with involved home nurses n = 1 x 5.
- Focus group interview with health professionals involved at OUH at the end of the project n = 1.
- Registration of unplanned contact to the health service during the study period to account for any extra health care usage during home treatment via the app "My hospital" x 1 weekly n = 40
- Data on quality of life; EORTC custom built satisfaction questionnaire via the app "My hospital" = 5 times per patient.
- Registration of the patients evaluation of whether the use of the app "My hospital" can be useful in the future.
- Registration of patients' time used on treatment when at home or when at hospital including transport via the app "My hospital".
- Registration of the outpatient nurses' and home nurses time using the registration form via paper.
- Registration of patients general condition and possible side effects in order to clarify whether they are "fit" for treatment via the app "My hospital". This ensures that a cure that is not used is not prepared.
All Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the Danish National Health Authorities according national law within 7 days after awareness. Since this is not at clinical trial, but merely a collection of data during a different logistics setup, the study will be submitted to the Danish Data Protection Agency, however not to the Danish National Ethical Committee nor the Danish National Health Authorities. Due to this Adverse Reactions (AEs) will not be systematically registered or reported to the Danish national health authorities. To make sure the logistics setup is safe for all patients we will register all unplanned hospitalizations as well as all other related Serious Adverse Reactions (SAR).
Processing of personal data in the project The project is notified to the Region's Register so that it complies with the Data Protection Regulation (GDPR). All electronic data will be stored on a secure SharePoint site that can only be accessed via the project group's work computer. All physical material is stored behind double-locked doors at the project group's workplace.
- Conditions
- Multiple Myeloma
- Being tested
- Darzalex
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarzalexDrug
Also called Daratumumab
Investigate the home administration of Darzalex SC reported by both patients and healthcare professionals compared to the hospital administration setting.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma | 40 patients with Multiple Myeloma in Department of Hematology at Odense University Hospital, Denmark Receives: Drug: Darzalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction reported by semi-structured interviews and patient reported outcome measurements (PROM)
To analyse changes in QoL measured by EORTC IL90
Measured: 01.04.2022-01.08.2024
Secondary outcomes (4)
Examination of patients' time spend on treatment in minutes
Examination of patients' time spend on treatment in minutes through an app on a smartphone.
Measured: 01.04.2022-01.08.2024
Examination of healthcare professionals' time spend on treatment in minutes
Examination of healthcare professionals' time spend on treatment in minutes on paper
Measured: 01.04.2022-01.08.2024
Examination of healthcare professionals' satisfaction using focus group interview
Examination of healthcare professionals' satisfaction using focus group interview at end of study
Measured: 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
Examination of financial perspective through calculations healthcare salaries based on time spend on treatment and transportation of medicatoin and/or patients through analysis of quantitative data
Measured: 01.04.2022-01.08.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Apr 2022
- Primary completion15 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Thomas Lund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Lund, Odense University Hospital
- Investigators
- Karin Dieperink, RN, PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306587
- Sponsor's protocol ID
- DAPHNE
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40165411
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab Provided at Home Experience: An Open, Single-center, Mixed-method Project Initiated on Behalf of Odense University Hospital
- ClinicalTrials.gov ID
- NCT05306587
- Acronym / sponsor ID
- DAPHNE
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas LundUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Apr 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.
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.
Detailed description
This study is a prospective, non-randomized, clinical parallel mixed-methods intervention project using qualitative and quantitative data in the form of semi-structured telephone interviews, focus group interviews, time registration, registration of patients' contact with the healthcare system and PRO data. The project will both include patients already being treated with SC Daratumumab and new patients planned to start Daratumumab treatment = 40 patients in all. The patients will be included in the department of hematology Odense University Hospital as they are found eligible.
The intervention of the study is home administration of Daratumumab SC by a home nurse, thereby, changing the administration setting from a hospital setting to at home setting. The intervention with home administration will be compared to the hospital setting. The patients will function as their own controls, as treatment will be given alternately at the hospital.
Patients scheduled for Daratumumab SC at home will be phoned by a nurse from the Hematology Outpatient Clinic the day before planned administration. This procedure is chosen as that it allows the nurse to determine whether it is justifiable, for the patient to receive treatment at home. If the nurse and doctor assess that the patient is fit for home administration of Daratumumab SC, the drug will be ordered at the pharmacy to be delivered to the patient the following day. Also an electronic message will also be sent to the home nurses with an instruction to administer Daratumumab SC between 12-02 PM.
Data collection will consist of:
- Semi-structured virtual (or alternative telephone) interviews with participating patients focusing on benefits / gains versus challenges / disadvantages in regard to the actual injection, collaboration with the home nurse, delivery of medication, empowerment, and suggestions for further improvements n = 2 x 10
- Semi-structured interviews with involved home nurses n = 1 x 5.
- Focus group interview with health professionals involved at OUH at the end of the project n = 1.
- Registration of unplanned contact to the health service during the study period to account for any extra health care usage during home treatment via the app "My hospital" x 1 weekly n = 40
- Data on quality of life; EORTC custom built satisfaction questionnaire via the app "My hospital" = 5 times per patient.
- Registration of the patients evaluation of whether the use of the app "My hospital" can be useful in the future.
- Registration of patients' time used on treatment when at home or when at hospital including transport via the app "My hospital".
- Registration of the outpatient nurses' and home nurses time using the registration form via paper.
- Registration of patients general condition and possible side effects in order to clarify whether they are "fit" for treatment via the app "My hospital". This ensures that a cure that is not used is not prepared.
All Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the Danish National Health Authorities according national law within 7 days after awareness. Since this is not at clinical trial, but merely a collection of data during a different logistics setup, the study will be submitted to the Danish Data Protection Agency, however not to the Danish National Ethical Committee nor the Danish National Health Authorities. Due to this Adverse Reactions (AEs) will not be systematically registered or reported to the Danish national health authorities. To make sure the logistics setup is safe for all patients we will register all unplanned hospitalizations as well as all other related Serious Adverse Reactions (SAR).
Processing of personal data in the project The project is notified to the Region's Register so that it complies with the Data Protection Regulation (GDPR). All electronic data will be stored on a secure SharePoint site that can only be accessed via the project group's work computer. All physical material is stored behind double-locked doors at the project group's workplace.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma | – | Drug: Darzalex40 patients with Multiple Myeloma in Department of Hematology at Odense University Hospital, Denmark |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients planned to start treatment with SC Darzalex or patients allready in treatment with SC Darzalex.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- receive other anti-myeloma treatment that require hospitalization with the exception of visit 1 in all cycles with Daratumumab SC administration.
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 |
|---|---|---|
| DarzalexAlso: DaratumumabInvestigate the home administration of Darzalex SC reported by both patients and healthcare professionals compared to the hospital administration setting. | Drug | Multiple Myeloma |
Primary outcome
Patients' satisfaction reported by semi-structured interviews and patient reported outcome measurements (PROM)
Time frame: 01.04.2022-01.08.2024
To analyse changes in QoL measured by EORTC IL90
4 secondary outcomes
Examination of patients' time spend on treatment in minutes
Time frame: 01.04.2022-01.08.2024
Examination of healthcare professionals' time spend on treatment in minutes
Time frame: 01.04.2022-01.08.2024
Examination of healthcare professionals' satisfaction using focus group interview
Time frame: 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
Time frame: 01.04.2022-01.08.2024
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 3 Apr 2024.
- Derived from this study: PubMed 40165411Rosenberg 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.
- Individual participant dataSharing planned: No
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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.
Karin Dieperink, RN, PhD 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 6 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 3 Apr 2024. 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 reported by semi-structured interviews and patient reported outcome measurements (PROM) (time frame: 01.04.2022-01.08.2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306587, which also lists 1 linked publication.
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 3 Apr 2024.