VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands
A Post Authorization Study, Designed to Learn More About the Safety and Efficacy of the Use of VELCADE (Bortezomib) in the Netherlands
2 other identifiers
observational
331
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
Longer than P75 for all trials
44 active sites
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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 14, 2014
January 1, 2014
7.2 years
February 26, 2007
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment; determination of response, duration of response, determination of relapse/progression
no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.
Secondary Outcomes (4)
bortezomib treatment schedule used
each cycle
combination therapies for multiple myeloma
from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
from end of bortezomib treatment up to 3 years after last bortezomib administration
Study Arms (1)
001
bortezomib dose as determined (observational study) by treating physician
Interventions
Eligibility Criteria
Multiple Myeloma patients treated with bortezomib in second or later line of therapy
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
's-Hertogenbosch, Netherlands
Unknown Facility
Alkmaar, Netherlands
Unknown Facility
Amersfoort, Netherlands
Unknown Facility
Amstelveen, Netherlands
Unknown Facility
Amsterdam-Zuidoost, Netherlands
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Bergen op Zoom, Netherlands
Unknown Facility
Blaricum, Netherlands
Unknown Facility
Breda, Netherlands
Unknown Facility
Capelle Aan Den Ijss, Netherlands
Unknown Facility
Delfzijl, Netherlands
Unknown Facility
Deventer, Netherlands
Unknown Facility
Dirksland, Netherlands
Unknown Facility
Doetinchem, Netherlands
Unknown Facility
Dordrecht, Netherlands
Unknown Facility
Drachten, Netherlands
Unknown Facility
Ede Gld, Netherlands
Unknown Facility
Eindhoven, Netherlands
Unknown Facility
Flushing, Netherlands
Unknown Facility
Geldrop, Netherlands
Unknown Facility
Goes, Netherlands
Unknown Facility
Gouda, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Hardenberg, Netherlands
Unknown Facility
Heerenveen, Netherlands
Unknown Facility
Hoofddorp, Netherlands
Unknown Facility
Hoogeveen, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Maastricht, Netherlands
Unknown Facility
Nieuwegein, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Oss, Netherlands
Unknown Facility
Roosendaal, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Schiedam, Netherlands
Unknown Facility
Terneuzen, Netherlands
Unknown Facility
The Hague, Netherlands
Unknown Facility
Tilburg, Netherlands
Unknown Facility
Utrecht, Netherlands
Unknown Facility
Veghel, Netherlands
Unknown Facility
Veldhoven, Netherlands
Unknown Facility
Woerden, Netherlands
Unknown Facility
Zaandam, Netherlands
Unknown Facility
Zutphen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag B.V. Clinical Trial
Janssen-Cilag B.V.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2007
First Posted
February 27, 2007
Study Start
November 1, 2004
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 14, 2014
Record last verified: 2014-01