Multiple MyelomaNCT00440479
ADVANCE: An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies.
An observational study of Multiple Myeloma and Hematological Neoplasms, run by Janssen-Cilag B.V. at 9 sites in Netherlands.
Trial summary
The primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies. 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
- 11 participants
- Where
- 9 sitesNetherlands
- Study dates
- Sep 2006to Jan 2011
- 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 at first relapse after participation in first line HOVON 49 or 50 clinical studies
Who may be able to join
- Patients have to sign a statement that they agree with collection of their clinical data for this project
- patients had a first relapse or progressive disease after treatment in the HOVON-49 or HOVON-50 study and will be treated with bortezomib.
Who cannot join
- Prior enrollment in HOVON-54 study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Study site
Bergen op Zoom
Study site
Breda
Study site
Ede Gld
Study site
Flushing
Study site
Nijmegen
Study site
Rotterdam
Study site
Terneuzen
Study site
Tilburg
Study site
Utrecht
About this study
Official title: An Observational Study To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)
The primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies.
Read the detailed description
There is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line. For that reason the current study, ADVANCE, is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments (i.e. patients who participated in the HOVON-49 or HOVON-50 study). In both HOVON studies patients were randomized to either receiving thalidomide or not, as a part of the first line treatment. Therefore, the effect of pre-treatment with thalidomide on duration, effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically. The analysis of this particular type of data will, however, be descriptive. All adverse events, regardless of seriousness, severity, or presumed relationship to bortezomib therapy will be recorded on the case report form, i.e., a form for each patient in the study on which all needed data are recorded, and reported to the sponsor within current timelines. The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities. This project is a 'post authorization study (PAS)'. This means that only routinely available medical data are 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 the 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
Measured: No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration
Secondary outcomes (4)
bortezomib treatment schedule, dosing and timing
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 startSep 2006
- Primary completionJan 2011
- Study completionJan 2011
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
- 11 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
- NCT00440479
- Sponsor's protocol ID
- CR012361
- Other IDs
- 26866138MMY4013
- Status last verified
- Apr 2015
- First submitted
- 26 Feb 2007
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)
- ClinicalTrials.gov ID
- NCT00440479
- Acronym / sponsor ID
- CR012361
- Conditions
- Multiple Myeloma, Hematological Neoplasms
- Keywords
- Multiple Myeloma, hematological neoplasms, chemotherapy, efficacy, safety, bortezomib, proteasome inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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 primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies.
Detailed description
There is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line. For that reason the current study, ADVANCE, is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments (i.e. patients who participated in the HOVON-49 or HOVON-50 study). In both HOVON studies patients were randomized to either receiving thalidomide or not, as a part of the first line treatment. Therefore, the effect of pre-treatment with thalidomide on duration, effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically. The analysis of this particular type of data will, however, be descriptive. All adverse events, regardless of seriousness, severity, or presumed relationship to bortezomib therapy will be recorded on the case report form, i.e., a form for each patient in the study on which all needed data are recorded, and reported to the sponsor within current timelines. The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities. This project is a 'post authorization study (PAS)'. This means that only routinely available medical data are 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 the 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 at first relapse after participation in first line HOVON 49 or 50 clinical studies
Key inclusion criteria (2 listed)
- Patients have to sign a statement that they agree with collection of their clinical data for this project
- patients had a first relapse or progressive disease after treatment in the HOVON-49 or HOVON-50 study and will be treated with bortezomib.
Key exclusion criteria (1 listed)
- Prior enrollment in HOVON-54 study
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
Time frame: No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration
4 secondary outcomes
bortezomib treatment schedule, dosing and timing
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 16 Apr 2015.
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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.
9 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 9 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 (time frame: No timepoints have been defined, as this is an observational study; data will be collected until three years after latest 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 16 Apr 2015.