Multiple MyelomaNCT05163405
Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
An observational study of Multiple Myeloma, run by Karin B. Ø. Dieperink at 1 site in Denmark.
Trial summary
In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 1 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Multiple Myeloma in treatment with Velcade in Department of Hematology X, outpatient clinic, at Odense University Hospital.
Who may be able to join
- Patients must have Multiple Myeloma
- Patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous Velcade
- Patients must be able to understand and speak Danish
- Patients must have received a minimum of 1 treatment cycle in the outpatient clinic
Who cannot join
- Lack of willingness to participate in scheduled interviews
- Patients who are cognitively affected
- Must not be receiving trial treatment
Trial locations and contacts
1 site in 1 country.
About this study
In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. In keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. To highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. Moreover, time registration of medication administration both at the hospital and in the patients' home is done. The qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
Self-administration of subcutaneously Velcade.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients experience of self-administration of Velcade
Qualitative interviews with all 10 included patients
Measured: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Secondary outcomes (3)
Organizational perspective
Patients and health professionals (including pharmacy staff) registration of time spend on treatment on all 10 included patients.
Measured: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Health care perspective
Focus group interview with healthcare professionals involved in the treatment.
Measured: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Financial perspective
Evaluation of financial savings on home treatment including healthcare salaries and transportation.
Measured: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Dec 2019
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karin B. Ø. Dieperink
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karin B. Ø. Dieperink, Odense University Hospital
- Investigators
- Karin Brochstedt Dieperink, RN, Study director, Odense University Hospital. Department of Oncology.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163405
- Sponsor's protocol ID
- Velcade at home
- Status last verified
- Aug 2025
- First submitted
- 3 Dec 2021
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
- ClinicalTrials.gov ID
- NCT05163405
- Acronym / sponsor ID
- Velcade at home
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karin B. Ø. DieperinkUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Dec 2021 (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.
In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. In keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. To highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. Moreover, time registration of medication administration both at the hospital and in the patients' home is done. The qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Multiple Myeloma in treatment with Velcade in Department of Hematology X, outpatient clinic, at Odense University Hospital.
Key inclusion criteria (4 listed)
- Patients must have Multiple Myeloma
- Patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous Velcade
- Patients must be able to understand and speak Danish
- Patients must have received a minimum of 1 treatment cycle in the outpatient clinic
Key exclusion criteria (3 listed)
- Lack of willingness to participate in scheduled interviews
- Patients who are cognitively affected
- Must not be receiving trial treatment
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 |
|---|---|---|
| BortezomibAlso: VelcadeSelf-administration of subcutaneously Velcade. | Drug | – |
Primary outcome
Patients experience of self-administration of Velcade
Time frame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Qualitative interviews with all 10 included patients
3 secondary outcomes
Organizational perspective
Time frame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Health care perspective
Time frame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Financial perspective
Time frame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
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 22 Aug 2025.
- 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 Brochstedt Dieperink, RN study director
Odense University Hospital. Department of Oncology.
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 Karin B. Ø. Dieperink 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 4 inclusion and 3 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 22 Aug 2025. 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 experience of self-administration of Velcade (time frame: Through study completion, from 01. dec. 2019 until 01. jun. 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.