Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05163405
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2021-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
Sponsor:
Karin B. Ø. Dieperink
Organization:
Study Overview
Official Title:
Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: