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000129105 0247_ $$2ISSN$$a1365-2141
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000129105 041__ $$aeng
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000129105 1001_ $$00000-0002-6226-1252$$aMai, Elias K$$b0
000129105 245__ $$aSingle versus tandem high-dose melphalan followed by autologous blood stem cell transplantation in multiple myeloma: long-term results from the phase III GMMG-HD2 trial.
000129105 260__ $$aOxford [u.a.]$$bWiley-Blackwell55962$$c2016
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000129105 520__ $$aThe prospective, randomized phase III trial GMMG-HD2 aimed at demonstrating non-inferiority of single (Arm A) versus tandem (Arm B) high-dose melphalan followed by autologous transplantation (HDM/ASCT) with regard to 2-year event-free survival (EFS) in newly-diagnosed multiple myeloma (MM) and included 358 evaluable patients [Intention-to-treat population, (ITT), single/tandem HDM/ASCT: n = 177/181]. After a median follow-up of more than 11 years, non-inferiority of single versus tandem HDM/ASCT was demonstrated using the planned non-inferiority threshold of 15% of the 2-year EFS rate. Neither EFS (P = 0·53) nor overall survival (OS) (P = 0·33) differences were observed in the ITT population. In the tandem arm, 26% (n = 47/181) of patients refused a second HDM/ASCT due to non-medical reasons. A per-protocol (PP) analysis, including patients who received the intervention (single/tandem HDM/ASCT: n = 156/93) and patients who did not receive a second HDM/ASCT due to medical reasons (12%, n = 22/181), did not yield differences in EFS (P = 0·61) or OS (P = 0·16). In the ITT and PP set of the tandem arm, the rates of complete responses increased from first to second HDM/ASCT (both P = 0·04). Ten-year OS for the entire ITT was 34% (95% confidence interval: 29-40%). OS after first relapse was significantly shortened in the tandem arm (P = 0·04). In this study single HDM/ASCT was non-inferior to tandem HDM/ASCT in MM.
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000129105 650_7 $$2NLM Chemicals$$aMyeloablative Agonists
000129105 650_7 $$0Q41OR9510P$$2NLM Chemicals$$aMelphalan
000129105 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b1$$udkfz
000129105 7001_ $$aBertsch, Uta$$b2
000129105 7001_ $$aBrossart, Peter$$b3
000129105 7001_ $$aHänel, Annette$$b4
000129105 7001_ $$aKunzmann, Volker$$b5
000129105 7001_ $$aNaumann, Ralph$$b6
000129105 7001_ $$aNeben, Kai$$b7
000129105 7001_ $$aEgerer, Gerlinde$$b8
000129105 7001_ $$aHo, Anthony D$$b9
000129105 7001_ $$aHillengass, Jens$$b10
000129105 7001_ $$00000-0003-4181-6922$$aRaab, Marc S$$b11
000129105 7001_ $$aNeubauer, Andreas$$b12
000129105 7001_ $$aPeyn, Astrid$$b13
000129105 7001_ $$aKo, Yon-Dschun$$b14
000129105 7001_ $$aPeter, Norma$$b15
000129105 7001_ $$aScheid, Christof$$b16
000129105 7001_ $$0P:(DE-He78)a1aa959d47e3e026abe157a8adf24b96$$aGoldschmidt, Hartmut$$b17$$eLast author$$udkfz
000129105 773__ $$0PERI:(DE-600)1475751-5$$a10.1111/bjh.13994$$gVol. 173, no. 5, p. 731 - 741$$n5$$p731 - 741$$tBritish journal of haematology$$v173$$x0007-1048$$y2016
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