Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440765
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2007-02-26
Brief Title:
VALEO A Post Authorization Study Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands
Sponsor:
Janssen-Cilag BV
Organization:
Janssen-Cilag BV
Study Overview
Official Title:
A Post Authorization Study Designed to Learn More About the Safety and Efficacy of the Use of VELCADE Bortezomib in the Netherlands
Status:
COMPLETED
Status Verified Date:
2014-01
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 main purpose of this study is to evaluate safety and effectiveness of the treatment of multiple myeloma with bortezomib in daily practice in the Netherlands
Detailed Description:
Bortezomib has become commercially available in the European Union in May 2004 for the third line treatment of patients with multiple myeloma The registration was based on two phase II studies while more research was ongoing Some experience was already gained with the use of this product in the Netherlands by means of a compassionate use program before the initial registration However the data available from the use of bortezomib in daily clinical practice is limited Therefore there is a need to closely study the use of bortezomib in daily clinical practice During the course of the study the registration of bortezomib was extended In April 2005 bortezomib was registered for second line treatment of multiple myeloma Consequently safety and effectiveness data from patients in this line of treatment could be collected in this project as well arm A Data of a large phase 3 trial showed that response rates differ between patients treated for multiple myeloma in the second line and patients treated in the third line Therefore the protocol was amended to compare the response rates in two arms dependent on the number of previous treatment lines for multiple myeloma The protocol was also amended to determine the time to progression and response rate in both patients who received thalidomide earlier versus patients who didnt arm B ARM A Patients with relapsed multiple myeloma who have received not more than 1 previous line of treatment and show progression on that therapy ARM B Patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of treatment and show progression on most recent therapy This project is a post authorization study PAS This means that only routinely available medical data is 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 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 |
|---|---|---|---|
| 26866138MMY4001 | None | None | None |