Einsele H, et al. - This work was planned to determine the safety and efficacy of bortezomib, cyclophosphamide and dexamethasone (VCD) induction therapy in previously untreated multiple myeloma patients. Findings suggested VCD as an effective and tolerable induction regimen. Here, VCD induced high response rates irrespective of cytogenetic risk status, however, after long-term follow-up, cytogenetic high risk seemed associated with markedly reduced progression-free survival (PFS) and overall survival (OS) post-autologous stem-cell transplantation (ASCT).

Methods

• Three 21-day cycles of VCD were admininstered to 414 patients prior to ASCT.

Results

• Leucopenia (31·4%) and thrombocytopenia (6·8%) were identified as the most common grade ≥3 adverse events.
• With respect to investigator-based assessment, the overall response rate (ORR) was 85·4%.
• Central laboratory-based molecular cytogenetic analysis was performed successfully on most patients (74%).
• There appeared no clinically relevant differences in ORR post-induction between patients with or without high-risk cytogenetic abnormalities (86.2% vs. 84.3%).
• For 113 patients receiving ASCT who were included in a prospective consolidation trial (median follow-up, 55.5 months), further follow-up data were available; median progression-free survival (PFS) was 35.3 months and median overall survival (OS) was not reached.
• In this work, patients with high-risk versus standard-risk cytogenetics indicated median PFS of 19·9 vs. 43·6 months (P < 0·0001), and median OS of 54·7 months versus not reached (P = 0·0022).