Background: In Germany, bortezomib is approved for the therapy of relapsed multiple myeloma since 2004. The data which had led to the approval were based on strictly selected patients. However, no data had been recorded on bortezomib in routine practice. Materials and Methods: In this non-interventional study, bortezomib was studied under routine conditions by office-based haematologists. Data were obtained prospectively following a protocol approved by the responsible Ethics Committee. Treatment followed the prescribing information and was documented for a maximum of 8 cycles. Any therapeutic or diagnostic intervention was left to the discretion of the attending physician. The primary endpoints were efficacy and safety. Results: Overall remission rate was 61% in patients evaluable for efficacy. Response rates were not significantly different between patients ≤70 and >70 years of age, nor between patients with and without renal impairment. The median time to best response was 3 cycles. Serious adverse events included thrombocytopenia (grade 3: 6%; grade 4: 8%), peripheral neuropathy (grade 3: 8%), fatigue, and bone pain (grade 3: 6% each; grade 4: 2% each) and anaemia (grade 3: 4%). Conclusion: The efficacy and tolerability of bortezomib observed in daily practice are consistent with the results obtained in large-scale clinical trials.

Keywords:
Multiple myeloma, Bortezomib, Elderly patients, Renal impairment
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© 2009 S. Karger AG, Basel
2009
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