Trial Information

An Observational Study To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)

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