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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

Phase 4
18 Years
Not Enrolling
Multiple Myeloma, Hematological Neoplasms

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Trial Information

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

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.

Type of Study:


Study Design:

Observational Model: Case-Only

Outcome Measure:

Response to treatment; determination of response, duration of response, determination of relapse/progression

Outcome Time Frame:

no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.

Safety Issue:


Principal Investigator

Janssen-Cilag B.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag B.V.


Netherlands: Netherlands Medicines Evaluation Board

Study ID:




Start Date:

October 2004

Completion Date:

January 2012

Related Keywords:

  • Multiple Myeloma
  • Hematological Neoplasms
  • Multiple Myeloma
  • hematological Neoplasms
  • chemotherapy
  • efficacy
  • safety
  • bortezomib
  • proteasome inhibitor
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms