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Keywords:

  • multiple myeloma;
  • chemotherapy;
  • clinical trials

Summary

The effectiveness of melphalan plus dexamethasone (M-Dex) with melphalan plus prednisone (MP) as induction therapy and dexamethasone with observation as maintenance therapy was compared in 585 older patients with multiple myeloma. Randomization to the M-Dex arm was stopped as a result of an analysis performed which met a predetermined event-related criterion. Of 466 patients randomised to MP or M-Dex, no differences were detected in the respective median progression-free survivals (PFS) [1·8 vs. 1·9 years; Hazard Ratio (HR) = 0·88, 95% CI 0·72–1·07; P = 0·2] or overall survivals (OS) (2·5 vs. 2·7 years; HR = 0·91, 95% CI 0·74–1·11; P = 0·3). Of the initial 585 patients, 292 remained evaluable for maintenance therapy. Patients randomised to maintenance dexamethasone had a superior median PFS (2·8 years vs. 2·1 years; HR = 0·61, 95% CI 0·47–0·79; P = 0·0002). No difference in median OS was detected (4·1 years vs. 3·8 years; HR = 0·88, 95% CI 0·65–1·18; P = 0·4). The maintenance therapy results were robust when analysed by using two additional methodologies. Dexamethasone did not improve clinical outcome when combined with melphalan during induction; maintenance dexamethasone improved PFS, but this did not translate into a detectable survival advantage.