Clinical trial NCT00440765: VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Hematological Neoplasms
Keywords: Multiple Myeloma
hematological Neoplasms
chemotherapy
efficacy
safety
bortezomib
proteasome inhibitor
Lead sponsor: Janssen-Cilag B.V.
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Myeloma patients treated with bortezomib in second or later line of therapy

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.

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 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.

Primary outcomes:
measure: Response to treatment; determination of response, duration of response, determination of relapse/progression
timeFrame: no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.
Secondary outcomes:
measure: bortezomib treatment schedule used
timeFrame: each cycle
measure: combination therapies for multiple myeloma
timeFrame: from start of bortezomib treatment up to 30 days after last bortezomib administration
measure: adverse events
timeFrame: from start of bortezomib treatment up to 30 days after last bortezomib administration
measure: overall survival
timeFrame: from end of bortezomib treatment up to 3 years after last bortezomib administration
Other outcomes:
Locations:
city: 'S-Hertogenbosch
country: Netherlands
city: Alkmaar
country: Netherlands
city: Amersfoort
country: Netherlands
city: Amstelveen
country: Netherlands
city: Amsterdam Zuidoost
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Bergen Op Zoom
country: Netherlands
city: Blaricum
country: Netherlands
city: Breda
country: Netherlands
city: Capelle Aan Den Ijss
country: Netherlands
city: Delfzijl
country: Netherlands
city: Den Haag
country: Netherlands
city: Deventer
country: Netherlands
city: Dirksland
country: Netherlands
city: Doetinchem
country: Netherlands
city: Dordrecht
country: Netherlands
city: Drachten
country: Netherlands
city: Ede Gld
country: Netherlands
city: Eindhoven
country: Netherlands
city: Geldrop
country: Netherlands
city: Goes
country: Netherlands
city: Gouda
country: Netherlands
city: Groningen
country: Netherlands
city: Hardenberg
country: Netherlands
city: Heerenveen
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Hoogeveen
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oss
country: Netherlands
city: Roosendaal
country: Netherlands
city: Rotterdam
country: Netherlands
city: Schiedam
country: Netherlands
city: Terneuzen
country: Netherlands
city: Tilburg
country: Netherlands
city: Utrecht
country: Netherlands
city: Veghel
country: Netherlands
city: Veldhoven
country: Netherlands
city: Vlissingen
country: Netherlands
city: Woerden
country: Netherlands
city: Zaandam
country: Netherlands
city: Zutphen
country: Netherlands
Study officials:
affiliation: Janssen-Cilag B.V.
name: Janssen-Cilag B.V. Clinical Trial
role: STUDY_DIRECTOR
References: