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Continuous prednisolone versus conventional prednisolone with VMCP–interferon‐α2b as first‐line chemotherapy in elderly patients with multiple myeloma

We report on a randomised trial that aimed to compare the efficacy of continued daily prednisolone treatment during the entire induction phase, with prednisolone given for 2 weeks of each cycle in combination with VMCP (vincristine, melphalan, cyclophosphamide, prednisolone)–interferon‐α2b (IFN‐α2b) treatment in 299 previously untreated elderly patients (median age: 67 years) with multiple myeloma. After completion of induction treatment patients were randomised to IFN‐α2b with or without prednisolone, thrice weekly. Response rate was 62% in the continuous and 60% in the control arm (intent to treat analysis, P = 0·81). Progression‐free survival [median: 20 months vs. 19 months; hazard ratio (HR): 0·99, 95% confidence interval (CI): 0·74–1·33, P = 0·97] and overall survival (median: 34 months vs. 37 months; HR: 1·16, 95% CI: 0·85–1·59, P = 0·35) were similar in both groups. Reduced performance status (Eastern Cooperative Oncology Group, grades 2–4) was the predominant risk factor for poor survival followed by age >65 years, high β2‐microglobulin, and impaired renal function. There was more grades 3–4 dyspnoea and cardiac impairment and grades 1–2 hyperglycaemia, but less nausea, emesis and anaemia in patients on continuous prednisolone therapy. In conclusion, continuing prednisolone treatment during the entire duration of the induction phase with VMCP–IFN‐α2b did not improve outcome.