NCT05163405

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

December 3, 2021

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients experience of self-administration of Velcade

    Qualitative interviews with all 10 included patients

    Through study completion, from 01. dec. 2019 until 01. jun. 2022

Secondary Outcomes (3)

  • Organizational perspective

    Through study completion, from 01. dec. 2019 until 01. jun. 2022

  • Health care perspective

    Through study completion, from 01. dec. 2019 until 01. jun. 2022

  • Financial perspective

    Through study completion, from 01. dec. 2019 until 01. jun. 2022

Interventions

Self-administration of subcutaneously Velcade.

Also known as: Velcade

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Multiple Myeloma in treatment with Velcade in Department of Hematology X, outpatient clinic, at Odense University Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Lack of willingness to participate in scheduled interviews
  • Patients who are cognitively affected
  • Must not be receiving trial treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Karin Brochstedt Dieperink, RN

    Odense University Hospital. Department of Oncology.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse, PhD, Associate Professor

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 20, 2021

Study Start

December 1, 2019

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations