Status:
COMPLETED
VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands
Lead Sponsor:
Janssen-Cilag B.V.
Conditions:
Multiple Myeloma
Hematological Neoplasms
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Patients have to sign a statement that they agree with collection of their clinical data for this project
- the patient is eligible, in the investigator's opinion, based on the criteria in the summary of product characteristics for bortezomib
Exclusion
- If patients meet the eligibility criteria, there are no exclusion criteria.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00440765
Start Date
November 1 2004
End Date
January 1 2012
Last Update
January 14 2014
Active Locations (44)
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1
's-Hertogenbosch, Netherlands
2
Alkmaar, Netherlands
3
Amersfoort, Netherlands
4
Amstelveen, Netherlands