Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440479
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2007-02-26
Brief Title:
ADVANCE An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-4950 Clinical Studies
Sponsor:
Janssen-Cilag BV
Organization:
Janssen-Cilag BV
Study Overview
Official Title:
An Observational Study To Determine Velcade Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-4950 Clinical Studies ADVANCE
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies
Detailed Description:
There is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line For that reason the current study ADVANCE is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments ie patients who participated in the HOVON-49 or HOVON-50 study In both HOVON studies patients were randomized to either receiving thalidomide or not as a part of the first line treatment Therefore the effect of pre-treatment with thalidomide on duration effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically The analysis of this particular type of data will however be descriptive All adverse events regardless of seriousness severity or presumed relationship to bortezomib therapy will be recorded on the case report form ie a form for each patient in the study on which all needed data are recorded and reported to the sponsor within current timelines The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities This project is a post authorization study PAS This means that only routinely available medical data are collected with the patients permission and no additional interventions or diagnostic procedures should be done specifically for this study Because the study is observational dosage administration and duration of treatment is at discretion of the treating physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 26866138MMY4013 | None | None | None |