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Single versus tandem high-dose melphalan followed by autologous blood stem cell transplantation in multiple myeloma: long-term results from the phase III GMMG-HD2 trial

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 inclu...

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Main Authors: Mai, Elias K. (Author) , Bertsch, Uta (Author) , Egerer, Gerlinde (Author) , Ho, Anthony Dick (Author) , Hillengaß, Jens (Author) , Raab, Marc-Steffen (Author) , Goldschmidt, Hartmut (Author)
Format: Article (Journal)
Language:English
Published: 17 March 2016
In: British journal of haematology
Year: 2016, Volume: 173, Issue: 5, Pages: 731-741
ISSN:1365-2141
DOI:10.1111/bjh.13994
Online Access:Verlag, Volltext: https://doi.org/10.1111/bjh.13994
Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/bjh.13994
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Author Notes:Elias K. Mai, Axel Benner, Uta Bertsch, Peter Brossart, Annette Hänel, Volker Kunzmann, Ralph Naumann, Kai Neben, Gerlinde Egerer, Anthony D. Ho, Jens Hillengass, Marc S. Raab, Andreas Neubauer, Astrid Peyn, Yon-Dschun Ko, Norma Peter, Christof Scheid and Hartmut Goldschmidt
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Summary: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.
Item Description:Gesehen am 14.08.2019
Physical Description:Online Resource
ISSN:1365-2141
DOI:10.1111/bjh.13994

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