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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag B.V.
ClinicalTrials.gov Identifier:
NCT00440765
First received: February 26, 2007
Last updated: January 13, 2014
Last verified: January 2014

February 26, 2007
January 13, 2014
November 2004
January 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00440765 on ClinicalTrials.gov Archive Site
  • bortezomib treatment schedule used [ Time Frame: each cycle ] [ Designated as safety issue: No ]
  • combination therapies for multiple myeloma [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: from end of bortezomib treatment up to 3 years after last bortezomib administration ] [ Designated as safety issue: No ]
Not Provided
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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

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.

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.

Observational
Observational Model: Case-Only
Not Provided
Not Provided
Non-Probability Sample

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

  • Multiple Myeloma
  • Hematological Neoplasms
Drug: bortezomib
dose as determined (observational study) by treating physician
001
bortezomib dose as determined (observational study) by treating physician
Intervention: Drug: bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00440765
CR003469, 26866138MMY4001
No
Janssen-Cilag B.V.
Janssen-Cilag B.V.
Not Provided
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
Janssen-Cilag B.V.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP