VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands

NCT ID: NCT00440765

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 331 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2012-01-31

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 didn't (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.

Conditions

Multiple Myeloma; Hematological Neoplasms

Study Design

• Observational Model Type: CASE_ONLY

Study Groups

001

bortezomib dose as determined (observational study) by treating physician

bortezomib

Intervention Type: DRUG

dose as determined (observational study) by treating physician

Interventions

bortezomib

dose as determined (observational study) by treating physician

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag B.V.

Locations

's-Hertogenbosch, , Netherlands

Alkmaar, , Netherlands

Amersfoort, , Netherlands

Amstelveen, , Netherlands

Amsterdam-Zuidoost, , Netherlands

Apeldoorn, , Netherlands

Bergen op Zoom, , Netherlands

Blaricum, , Netherlands

Breda, , Netherlands

Capelle Aan Den Ijss, , Netherlands

Delfzijl, , Netherlands

Deventer, , Netherlands

Dirksland, , Netherlands

Doetinchem, , Netherlands

Dordrecht, , Netherlands

Drachten, , Netherlands

Ede Gld, , Netherlands

Eindhoven, , Netherlands

Flushing, , Netherlands

Geldrop, , Netherlands

Goes, , Netherlands

Gouda, , Netherlands

Groningen, , Netherlands

Hardenberg, , Netherlands

Heerenveen, , Netherlands

Hoofddorp, , Netherlands

Hoogeveen, , Netherlands

Leiden, , Netherlands

Maastricht, , Netherlands

Nieuwegein, , Netherlands

Nijmegen, , Netherlands

Oss, , Netherlands

Roosendaal, , Netherlands

Rotterdam, , Netherlands

Schiedam, , Netherlands

Terneuzen, , Netherlands

The Hague, , Netherlands

Tilburg, , Netherlands

Utrecht, , Netherlands

Veghel, , Netherlands

Veldhoven, , Netherlands

Woerden, , Netherlands

Zaandam, , Netherlands

Zutphen, , Netherlands

Countries

Netherlands

Other Identifiers

26866138MMY4001

Identifier Type: -

Identifier Source: secondary_id

CR003469

Identifier Type: -

Identifier Source: org_study_id