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
  Purpose

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 Intervention Phase
Multiple Myeloma
Hematological Neoplasms
Drug: bortezomib
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag B.V.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 331
Study Start Date: November 2004
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
bortezomib dose as determined (observational study) by treating physician
Drug: bortezomib
dose as determined (observational study) by treating physician

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440765

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
Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

No publications provided

Responsible Party: Janssen-Cilag B.V.
ClinicalTrials.gov Identifier: NCT00440765     History of Changes
Other Study ID Numbers: CR003469, 26866138MMY4001
Study First Received: February 26, 2007
Last Updated: January 13, 2014
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

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

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014