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@ARTICLE{Mai:129105,
      author       = {E. K. Mai and A. Benner$^*$ and U. Bertsch and P. Brossart
                      and A. Hänel and V. Kunzmann and R. Naumann and K. Neben
                      and G. Egerer and A. D. Ho and J. Hillengass and M. S.
                      Raab$^*$ and A. Neubauer and A. Peyn and Y.-D. Ko and N.
                      Peter and C. Scheid and H. Goldschmidt$^*$},
      title        = {{S}ingle versus tandem high-dose melphalan followed by
                      autologous blood stem cell transplantation in multiple
                      myeloma: long-term results from the phase {III} {GMMG}-{HD}2
                      trial.},
      journal      = {British journal of haematology},
      volume       = {173},
      number       = {5},
      issn         = {0007-1048},
      address      = {Oxford [u.a.]},
      publisher    = {Wiley-Blackwell55962},
      reportid     = {DKFZ-2017-05110},
      pages        = {731 - 741},
      year         = {2016},
      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.},
      keywords     = {Myeloablative Agonists (NLM Chemicals) / Melphalan (NLM
                      Chemicals)},
      cin          = {G330 / C060 / G170 / V964},
      ddc          = {610},
      cid          = {I:(DE-He78)G330-20160331 / I:(DE-He78)C060-20160331 /
                      I:(DE-He78)G170-20160331 / I:(DE-He78)V964-20160331},
      pnm          = {317 - Translational cancer research (POF3-317)},
      pid          = {G:(DE-HGF)POF3-317},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:26990892},
      doi          = {10.1111/bjh.13994},
      url          = {https://inrepo02.dkfz.de/record/129105},
}