Journal Article

DKFZ-2017-05110

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png 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.

Mai, E. K. ; Benner, A.DKFZ* ; Bertsch, U. ; Brossart, P. ; Hänel, A. ; Kunzmann, V. ; Naumann, R. ; Neben, K. ; Egerer, G. ; Ho, A. D. ; Hillengass, J. ; Raab, M. S.DKFZ* ; Neubauer, A. ; Peyn, A. ; Ko, Y.-D. ; Peter, N. ; Scheid, C. ; Goldschmidt, H. (Last author)DKFZ*

2016
Wiley-Blackwell55962 Oxford [u.a.]

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Please use a persistent id in citations: doi:10.1111/bjh.13994

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 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.

Keyword(s): Myeloablative Agonists ; Melphalan

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Contributing Institute(s):

1. KKE Molekulare Hämatologie/Onkologie (G330)
2. Biostatistik (C060)
3. Experimentelle Therapien hämatologischer Neoplasien (G170)
4. NCT-KliHD (V964)

Research Program(s):

1. 317 - Translational cancer research (POF3-317) (POF3-317)

Appears in the scientific report 2016

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Database coverage:
; BIOSIS Previews ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 5 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Thomson Reuters Master Journal List ; Web of Science Core Collection

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