% IMPORTANT: The following is UTF-8 encoded.  This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.

@ARTICLE{Salwender:143878,
      author       = {H. Salwender and U. Bertsch and K. Weisel and J. Duerig and
                      C. Kunz$^*$ and A. Benner$^*$ and I. W. Blau and M. S. Raab
                      and J. Hillengass and D. Hose and S. Huhn and M. Hundemer
                      and M. Andrulis and A. Jauch and A. Seidel-Glaetzer and
                      H.-W. Lindemann and M. Hensel and S. Fronhoffs and U.
                      Martens and T. Hansen and M. Wattad and U. Graeven and M.
                      Munder and R. Fenk and M. Haenel and C. Scheid and H.
                      Goldschmidt},
      title        = {{R}ationale and design of the {G}erman-speaking myeloma
                      multicenter group ({GMMG}) trial {HD}6: a randomized phase
                      {III} trial on the effect of elotuzumab in {VRD}
                      induction/consolidation and lenalidomide maintenance in
                      patients with newly diagnosed myeloma.},
      journal      = {BMC cancer},
      volume       = {19},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2019-01440},
      pages        = {504},
      year         = {2019},
      abstract     = {Despite major advances in therapy, multiple myeloma is
                      still an incurable malignancy in the majority of patients.
                      To increase survival, deeper remissions (i.e. CR)
                      translating into longer PFS need to be achieved.
                      Incorporation of new drugs (i.e. bortezomib and
                      lenalidomide) as induction and maintenance treatment in an
                      intensified treatment concept, including high dose melphalan
                      (200 mg/m2), has resulted in increased CR rates, and is
                      considered the standard of care for younger patients.
                      Elotuzumab in combination with lenalidomide and
                      dexamethasone has given better results as lenalidomide and
                      dexamethasone alone in a phase III trial. The GMMG-HD6 trial
                      will be the first phase III trial investigating the role of
                      elotuzumab in combination with bortezomib, lenalidomide and
                      dexamethasone (VRD) induction/consolidation and lenalidomide
                      maintenance within a high dose concept.GMMG-HD6 is a
                      randomized, open, multicenter phase III trial. The planned
                      recruitment number is 564 NDMM patients. All patients will
                      receive 4 VRD cycles as induction and undergo peripheral
                      blood stem cell mobilization and harvesting. Thereafter they
                      will be treated with high dose melphalan therapy plus
                      autologous stem cell transplantation followed by 2 cycles
                      of VRD consolidation and lenalidomide maintenance. Patients
                      in arm B1 + B2 will additionally receive elotuzumab in
                      the induction phase, whereas patients in A2 + B2 will be
                      treated with elotuzumab added to consolidation and
                      maintenance. The primary endpoint of the trial is PFS.
                      Secondary objectives and endpoints are OS, CR rates after
                      induction therapy comparing the two arms VRD (A1 + A2)
                      vs VRD + elotuzumab (B1 + B2), CR rates after
                      consolidation treatment, best response to treatment during
                      the study, time to progression (TTP), duration of response
                      (DOR), toxicity and quality of life.Since this is the
                      publication of a study protocol of an ongoing study, no
                      results can be presented.This phase III trial is designed to
                      evaluate whether the addition of elotuzumab to an
                      intensified treatment concept with high dose melphalan
                      chemotherapy plus autologous stem cell transplantation and
                      induction, consolidation and maintenance treatment with
                      bortezomib and lenalidomide is able to improve PFS compared
                      to the same concept without elotuzumab.NCT02495922 on June
                      24th, 2015.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:31138244},
      doi          = {10.1186/s12885-019-5600-x},
      url          = {https://inrepo02.dkfz.de/record/143878},
}