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 To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)
2 other identifiers
observational
11
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2006
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedApril 16, 2015
April 1, 2015
4.3 years
February 26, 2007
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment
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
each cycle
combination therapies for multiple myeloma
from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
from end of bortezomib treatment up to 3 years after last bortezomib administration
Study Arms (1)
001
Bortezomib dose as determined (observational study) by treating physician
Interventions
Eligibility Criteria
Multiple Myeloma patients treated with bortezomib at first relapse after participation in first line HOVON 49 or 50 clinical studies
You may qualify if:
- 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.
You may not qualify if:
- Prior enrollment in HOVON-54 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Bergen op Zoom, Netherlands
Unknown Facility
Breda, Netherlands
Unknown Facility
Ede Gld, Netherlands
Unknown Facility
Flushing, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Terneuzen, Netherlands
Unknown Facility
Tilburg, Netherlands
Unknown Facility
Utrecht, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag B.V. Clinical Trial
Janssen-Cilag B.V.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2007
First Posted
February 27, 2007
Study Start
September 1, 2006
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
April 16, 2015
Record last verified: 2015-04