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

January 13, 2014 updated by: Janssen-Cilag B.V.

A Post Authorization Study, Designed to Learn More About the Safety and Efficacy of the Use of VELCADE (Bortezomib) in the Netherlands

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • '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
      • Den Haag, Netherlands
      • Deventer, Netherlands
      • Dirksland, Netherlands
      • Doetinchem, Netherlands
      • Dordrecht, Netherlands
      • Drachten, Netherlands
      • Ede Gld, Netherlands
      • Eindhoven, 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
      • Tilburg, Netherlands
      • Utrecht, Netherlands
      • Veghel, Netherlands
      • Veldhoven, Netherlands
      • Vlissingen, Netherlands
      • Woerden, Netherlands
      • Zaandam, Netherlands
      • Zutphen, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple Myeloma patients treated with bortezomib in second or later line of therapy

Description

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

Exclusion Criteria:

  • If patients meet the eligibility criteria, there are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
bortezomib dose as determined (observational study) by treating physician
Drug: bortezomib
dose as determined (observational study) by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment; determination of response, duration of response, determination of relapse/progression
Time Frame: no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.
no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.

Secondary Outcome Measures

Outcome Measure
Time Frame
combination therapies for multiple myeloma
Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
Time Frame: from end of bortezomib treatment up to 3 years after last bortezomib administration
from end of bortezomib treatment up to 3 years after last bortezomib administration
bortezomib treatment schedule used
Time Frame: each cycle
each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003469
  • 26866138MMY4001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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