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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma, Hematological Neoplasms

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>bortezomib dose as determined (observational study) by treating physician | Drug: bortezomib<br>* dose as determined (observational study) by treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, hematological Neoplasms, chemotherapy, efficacy, safety, bortezomib, proteasome inhibitor