Randomized comparison of dexamethasone combined with melphalan versus melphalan with prednisone in the treatment of elderly patients with multiple myeloma.

ABSTRACT

Melphalan-prednisone (MP) has been the gold standard treatment for more than 30 years in elderly multiple myeloma (MM) patients. In order to assess whether the combination of dexamethasone with melphalan (MD) could improve on the efficacy of MP, we have carried out a randomized trial comparing both treatment approaches. A total of 201 patients >/=70 years old were included in the study. The overall response rate was similar after six cycles (MP 67.9%versus MD 64.5%) and after 12 cycles (MP 49.4%versus MD 46.1%). However, the proportion of complete responses (CR) was higher in the MD arm, particularly after 12 cycles (MD 22.4%versus MP 9.1%; P < 0.05). There was no significant difference in event-free survival (MP 15.9 months versus MD 23.3 months). The median overall survival in both arms was almost identical (MP 29.4 months versus MD 27.2 months; P = 0.63). No significant differences in haematological toxicity were observed, but non-haematological toxicity was significantly higher in the MD arm. According to these results MP remains as the gold standard for treatment of MM and should be the reference for comparison of new therapeutic approaches involving novel agents.