Search

The prospective, randomized phase III trial GMMG- HD2 aimed at demonstrating non-inferiority of single (Arm A) versus tandem (Arm B) high-dose melphalan followed by autologous transplantation ( HDM/ ASCT) with regard to 2-year event-free survival ( EFS) in newly-diagnosed multiple myeloma ( MM) and included 358 evaluable patients [Intention-to-treat population, ( ITT), single/tandem HDM/ ASCT: n = 177/181]. After a median follow-up of more than 11 years, non-inferiority of single versus tandem HDM/ ASCT was demonstrated using the planned non-inferiority threshold of 15% of the 2-year EFS rate. Neither EFS ( P = 0·53) nor overall survival ( OS) ( P = 0·33) differences were observed in the ITT population. In the tandem arm, 26% ( n = 47/181) of patients refused a second HDM/ ASCT due to non-medical reasons. A per-protocol ( PP) analysis, including patients who received the intervention (single/tandem HDM/ ASCT: n = 156/93) and patients who did not receive a second HDM/ ASCT due to medical reasons (12%, n = 22/181), did not yield differences in EFS ( P = 0·61) or OS ( P = 0·16). In the ITT and PP set of the tandem arm, the rates of complete responses increased from first to second HDM/ ASCT (both P = 0·04). Ten-year OS for the entire ITT was 34% (95% confidence interval: 29-40%). OS after first relapse was significantly shortened in the tandem arm ( P = 0·04). In this study single HDM/ ASCT was non-inferior to tandem HDM/ ASCT in MM. [ABSTRACT FROM AUTHOR]