Multiple MyelomaNCT00440765
VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands
An observational study of Multiple Myeloma and Hematological Neoplasms, run by Janssen-Cilag B.V. at 44 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Hematological Neoplasms
- What is being tested?
- bortezomib
- How many people
- 331 participants
- Where
- 44 sitesNetherlands
- Study dates
- Nov 2004to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Myeloma patients treated with bortezomib in second or later line of therapy
Who may be able to join
- 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
Who cannot join
- If patients meet the eligibility criteria, there are no exclusion criteria.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Netherlands44 sites
Study site
's-Hertogenbosch
Study site
Alkmaar
Study site
Amersfoort
Study site
Amstelveen
Study site
Amsterdam-Zuidoost
Study site
Apeldoorn
Study site
Bergen op Zoom
Study site
Blaricum
Study site
Breda
Study site
Capelle Aan Den Ijss
Study site
Delfzijl
Study site
Deventer
Study site
Dirksland
Study site
Doetinchem
Study site
Dordrecht
Study site
Drachten
Study site
Ede Gld
Study site
Eindhoven
Study site
Flushing
Study site
Geldrop
Study site
Goes
Study site
Gouda
Study site
Groningen
Study site
Hardenberg
Study site
Heerenveen
Study site
Hoofddorp
Study site
Hoogeveen
Study site
Leiden
Study site
Maastricht
Study site
Nieuwegein
Study site
Nijmegen
Study site
Oss
Study site
Roosendaal
Study site
Rotterdam
Study site
Schiedam
Study site
Terneuzen
Study site
The Hague
Study site
Tilburg
Study site
Utrecht
Study site
Veghel
Study site
Veldhoven
Study site
Woerden
Study site
Zaandam
Study site
Zutphen
About this study
Official title: A Post Authorization Study, Designed to Learn More About the Safety and Efficacy of the Use of VELCADE (Bortezomib) in the Netherlands
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.
Read the 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.
- Conditions
- Multiple Myeloma, Hematological Neoplasms
- Being tested
- bortezomib
- Keywords
- Multiple Myeloma, hematological Neoplasms, chemotherapy, efficacy, safety, bortezomib, proteasome inhibitor
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
dose as determined (observational study) by treating physician
| Study group | Role | What they receive |
|---|---|---|
| 001 | bortezomib dose as determined (observational study) by treating physician Receives: Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment; determination of response, duration of response, determination of relapse/progression
Measured: no timepoints are defined, as this is an observational study; data will be collected until three years after last bortezomib administration.
Secondary outcomes (4)
bortezomib treatment schedule used
Measured: each cycle
combination therapies for multiple myeloma
Measured: from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
Measured: from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
Measured: from end of bortezomib treatment up to 3 years after last bortezomib administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startNov 2004
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440765
- Sponsor's protocol ID
- CR003469
- Other IDs
- 26866138MMY4001
- Status last verified
- Jan 2014
- First submitted
- 26 Feb 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Authorization Study, Designed to Learn More About the Safety and Efficacy of the Use of VELCADE (Bortezomib) in the Netherlands
- ClinicalTrials.gov ID
- NCT00440765
- Acronym / sponsor ID
- CR003469
- Conditions
- Multiple Myeloma, Hematological Neoplasms
- Keywords
- Multiple Myeloma, hematological Neoplasms, chemotherapy, efficacy, safety, bortezomib, proteasome inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: bortezomibbortezomib dose as determined (observational study) by treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma patients treated with bortezomib in second or later line of therapy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- If patients meet the eligibility criteria, there are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibdose as determined (observational study) by treating physician | Drug | 001 |
Primary outcome
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.
4 secondary outcomes
bortezomib treatment schedule used
Time frame: each cycle
combination therapies for multiple myeloma
Time frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
Time frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
Time frame: from end of bortezomib treatment up to 3 years after last bortezomib administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Hematological Neoplasms, run by Janssen-Cilag B.V. at 44 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.