ADVANCE: An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies.
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.
|Study Design:||Observational Model: Case-Only|
|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)|
- 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 ] [ Designated as safety issue: No ]
- bortezomib treatment schedule, dosing and timing [ 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 ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||July 2011|
Bortezomib dose as determined (observational study) by treating physician
dose as determined (observational study) by treating physician
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440479
|Study Director:||Janssen-Cilag B.V. Clinical Trial||Janssen-Cilag B.V.|