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@ARTICLE{Mai:287484,
      author       = {E. K. Mai and H. Goldschmid and K. Miah$^*$ and U. Bertsch
                      and B. Besemer and M. Hänel and J. Krzykalla$^*$ and R.
                      Fenk and J. Schlenzka and M. Munder and J. Dürig and I. W.
                      Blau and S. Huhn and D. Hose and A. Jauch and C. Kunz$^*$
                      and C. Mann and N. Weinhold and C. Scheid and R. Schroers
                      and I. von Metzler and A. Schieferdecker and J. Thomalla and
                      P. Reimer and R. Mahlberg and U. Graeven and S. Kremers and
                      U. M. Martens and C. Kunz and M. Hensel and A. Benner$^*$
                      and A. Seidel-Glätzer and K. C. Weisel and M. S. Raab and
                      H. J. Salwender},
      collaboration = {G. M. M. Group},
      othercontributors = {N. Adrian and H. Bernhard and H.-P. Böck and C. Bolling
                          and G. Dingeldein and T.-O. Emde and B. Ferstl and T. Fietz
                          and S. Fronhoffs and S. Fuhrmann and S. Fuxius and T. Geer
                          and M. Görner and B. Guenther and F. Hartmann and B.
                          Heilmeier and M. Heinsch and M. Hoffmann and T. A. W.
                          Holderried and S. Klein and M. Klump and W. Knauf and P. La
                          Rosée and E. Lange and W. Lindemann and R. Lopez and F.
                          Mayer and H. Nückel and E. Papesch and M. Procaccianti and
                          A. Reichart and M. Rummel and L. Scheuer and H.-R. Schmitt
                          and P. Staib and H. Steiniger and H.-J. Tischler and T.
                          Ulshöfer and W. Verbeek and A. Wacker and I. Zirpel},
      title        = {{E}lotuzumab, lenalidomide, bortezomib, dexamethasone, and
                      autologous haematopoietic stem-cell transplantation for
                      newly diagnosed multiple myeloma ({GMMG}-{HD}6): results
                      from a randomised, phase 3 trial.},
      journal      = {The lancet / Haematology},
      volume       = {11},
      number       = {2},
      issn         = {2352-3026},
      address      = {London [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2024-00262},
      pages        = {e101 - e113},
      year         = {2024},
      abstract     = {The aim of this trial was to investigate the addition of
                      the anti-SLAMF7 monoclonal antibody elotuzumab to
                      lenalidomide, bortezomib, and dexamethasone (RVd) in
                      induction and consolidation therapy as well as to
                      lenalidomide maintenance treatment in transplant-eligible
                      patients with newly diagnosed multiple myeloma.GMMG-HD6 was
                      a phase 3, randomised trial conducted at 43 main trial sites
                      and 26 associated trial sites throughout Germany. Adult
                      patients (aged 18-70 years) with previously untreated,
                      symptomatic multiple myeloma, and a WHO performance status
                      of 0-3, with 3 being allowed only if caused by myeloma
                      disease and not by comorbid conditions, were randomly
                      assigned 1:1:1:1 to four treatment groups. Induction therapy
                      consisted of four 21-day cycles of RVd (lenalidomide 25 mg
                      orally on days 1-14; bortezomib 1·3 mg/m2 subcutaneously on
                      days 1, 4, 8, and 11]; and dexamethasone 20 mg orally on
                      days 1, 2, 4, 5, 8, 9, 11, 12, and 15 for cycles 1-2) or,
                      RVd induction plus elotuzumab (10 mg/kg intravenously on
                      days 1, 8, and 15 for cycles 1-2, and on days 1 and 11 for
                      cycles 3-4; E-RVd). Autologous haematopoietic stem-cell
                      transplantation was followed by two 21-day cycles of either
                      RVd consolidation (lenalidomide 25 mg orally on days 1-14;
                      bortezomib 1·3 mg/m2 subcutaneously on days 1, 8, and 15;
                      and dexamethasone 20 mg orally on days 1, 2, 8, 9, 15, and
                      16) or elotuzumab plus RVd consolidation (with elotuzumab 10
                      mg/kg intravenously on days 1, 8, and 15) followed by
                      maintenance with either lenalidomide (10 mg orally on days
                      1-28 for cycles 1-3; thereafter, up to 15 mg orally on days
                      1-28; RVd/R or E-RVd/R group) or lenalidomide plus
                      elotuzumab (10 mg/kg intravenously on days 1 and 15 for
                      cycles 1-6, and on day 1 for cycles 7-26; RVd/E-R or
                      E-RVd/E-R group) for 2 years. The primary endpoint was
                      progression-free survival analysed in a modified
                      intention-to-treat (ITT) population. Safety was analysed in
                      all patients who received at least one dose of trial
                      medication. This trial is registered with
                      ClinicalTrials.gov, NCT02495922, and is completed.Between
                      June 29, 2015, and on Sept 11, 2017, 564 patients were
                      included in the trial. The modified ITT population comprised
                      559 (243 $[43\%]$ females and 316 $[57\%]$ males) patients
                      and the safety population 555 patients. After a median
                      follow-up of 49·8 months (IQR 43·7-55·5), there was no
                      difference in progression-free survival between the four
                      treatment groups (adjusted log-rank p value, p=0·86), and
                      3-year progression-free survival rates were $69\%$ $(95\%$
                      CI 61-77), $69\%$ (61-76), $66\%$ (58-74), and $67\%$
                      (59-75) for patients treated with RVd/R, RVd/E-R, E-RVd/R,
                      and E-RVd/E-R, respectively. Infections (grade 3 or worse)
                      were the most frequently observed adverse event in all
                      treatment groups (28 $[20\%]$ of 137 for RVd/R; 32 $[23\%]$
                      of 138 for RVd/E-R; 35 $[25\%]$ of 138 for E-RVd/R; and 48
                      $[34\%]$ of 142 for E-RVd/E-R). Serious adverse events
                      (grade 3 or worse) were observed in 68 $(48\%)$ of 142
                      participants in the E-RVd/E-R group, 53 $(39\%)$ of 137 in
                      the RVd/R, 53 $(38\%)$ of 138 in the RVd/E-R, and 50
                      $(36\%)$ of 138 in the E-RVd/R $(36\%)$ group. There were
                      nine treatment-related deaths during the study. Two deaths
                      (one sepsis and one toxic colitis) in the RVd/R group were
                      considered lenalidomide-related. One death in the RVd/E-R
                      group due to meningoencephalitis was considered lenalidomide
                      and elotuzumab-related. Four deaths (one pulmonary embolism,
                      one septic shock, one atypical pneumonia, and one
                      cardiovascular failure) in the E-RVd/R group and two deaths
                      (one sepsis and one pneumonia and pulmonary fibrosis) in the
                      E-RVd/E-R group were considered related to lenalidomide or
                      elotuzumab, or both.Addition of elotuzumab to RVd induction
                      or consolidation and lenalidomide maintenance in patients
                      with transplant-eligible newly diagnosed multiple myeloma
                      did not provide clinical benefit. Elotuzumab-containing
                      therapies might be reserved for patients with relapsed or
                      refractory multiple myeloma.Bristol Myers Squibb/Celgene and
                      Chugai.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:38302221},
      doi          = {10.1016/S2352-3026(23)00366-6},
      url          = {https://inrepo02.dkfz.de/record/287484},
}