A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7

SummaryThe 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.

A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7 Journal Articles