Universität zu Köln

Mai, Elias K., Benner, Axel, Bertsch, Uta, Brossart, Peter, Haenel, Annette, Kunzmann, Volker, Naumann, Ralph, Neben, Kai, Egerer, Gerlinde, Ho, Anthony D., Hillengass, Jens, Raab, Marc S., Neubauer, Andreas, Peyn, Astrid, Ko, Yon-Dschun, Peter, Norma, Scheid, Christof and Goldschmidt, Hartmut (2016). 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. Br. J. Haematol., 173 (5). S. 731 - 742. HOBOKEN: WILEY. ISSN 1365-2141

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Abstract

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 11years, 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=053) nor overall survival (OS) (P=033) 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=061) or OS (P=016). In the ITT and PP set of the tandem arm, the rates of complete responses increased from first to second HDM/ASCT (both P=004). 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=004). In this study single HDM/ASCT was non-inferior to tandem HDM/ASCT in MM.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mai, Elias K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Benner, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Bertsch, Uta UNSPECIFIED UNSPECIFIED UNSPECIFIED Brossart, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Haenel, Annette UNSPECIFIED UNSPECIFIED UNSPECIFIED Kunzmann, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Naumann, Ralph UNSPECIFIED UNSPECIFIED UNSPECIFIED Neben, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Egerer, Gerlinde UNSPECIFIED UNSPECIFIED UNSPECIFIED Ho, Anthony D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillengass, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Raab, Marc S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Neubauer, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Peyn, Astrid UNSPECIFIED UNSPECIFIED UNSPECIFIED Ko, Yon-Dschun UNSPECIFIED UNSPECIFIED UNSPECIFIED Peter, Norma UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheid, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Goldschmidt, Hartmut UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-273763
DOI:	10.1111/bjh.13994
Journal or Publication Title:	Br. J. Haematol.
Volume:	173
Number:	5
Page Range:	S. 731 - 742
Date:	2016
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1365-2141
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RANDOMIZED-TRIAL; INTERGROUPE FRANCOPHONE; MARROW-TRANSPLANTATION; 200 MG/M(2); THERAPY; MAINTENANCE; BORTEZOMIB; INDUCTION; LENALIDOMIDE; CHEMOTHERAPY Multiple languages Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27376