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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440765
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Janssen-Cilag B.V.

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.

Condition or disease Intervention/treatment
Multiple Myeloma Hematological Neoplasms Drug: bortezomib

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
Actual Enrollment : 331 participants
Observational Model: Case-Only
Official Title: A Post Authorization Study, Designed to Learn More About the Safety and Efficacy of the Use of VELCADE (Bortezomib) in the Netherlands
Study Start Date : November 2004
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. bortezomib treatment schedule used [ Time Frame: each cycle ]
  2. combination therapies for multiple myeloma [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ]
  3. adverse events [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ]
  4. overall survival [ Time Frame: from end of bortezomib treatment up to 3 years after last bortezomib administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Myeloma patients treated with bortezomib in second or later line of therapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440765

'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
Sponsors and Collaborators
Janssen-Cilag B.V.
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.

Responsible Party: Janssen-Cilag B.V. Identifier: NCT00440765     History of Changes
Other Study ID Numbers: CR003469
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Janssen-Cilag B.V.:
Multiple Myeloma
hematological Neoplasms
proteasome inhibitor

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Antineoplastic Agents