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@ARTICLE{Leypoldt:283173,
      author       = {L. B. Leypoldt and D. Tichy$^*$ and B. Besemer and M.
                      Hänel and M. S. Raab and C. Mann and M. Munder and H. C.
                      Reinhardt$^*$ and A. Nogai and M. Görner and Y.-D. Ko and
                      M. de Wit and H. Salwender and C. Scheid and U. Graeven and
                      R. Peceny and P. Staib and A. Dieing and H. Einsele and A.
                      Jauch and M. Hundemer and M. Zago and E. Pozek$^*$ and A.
                      Benner$^*$ and C. Bokemeyer and H. Goldschmidt and K. C.
                      Weisel},
      title        = {{I}satuximab, {C}arfilzomib, {L}enalidomide, and
                      {D}examethasone for the {T}reatment of {H}igh-{R}isk {N}ewly
                      {D}iagnosed {M}ultiple {M}yeloma.},
      journal      = {Journal of clinical oncology},
      volume       = {42},
      number       = {1},
      issn         = {0732-183X},
      address      = {Alexandria, Va.},
      publisher    = {American Society of Clinical Oncology},
      reportid     = {DKFZ-2023-01952},
      pages        = {26-37},
      year         = {2024},
      note         = {2024 Jan 1;42(1):26-37},
      abstract     = {The GMMG-CONCEPT trial investigated isatuximab,
                      carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in
                      transplant-eligible (TE) and transplant-noneligible (TNE)
                      patients with newly diagnosed multiple myeloma (NDMM) with
                      exclusively high-risk disease for whom prospective trials
                      are limited, aiming to induce minimal residual disease (MRD)
                      negativity.This academic, investigator-initiated,
                      multicenter, phase II trial enrolled patients with high-risk
                      NDMM (HRNDMM) defined by mandatory International Staging
                      System stage II/III combined with del17p, t(4;14), t(14;16),
                      or more than three 1q21 copies as high-risk cytogenetic
                      aberrations (HRCAs). Patients received Isa-KRd
                      induction/consolidation and Isa-KR maintenance. TE patients
                      received high-dose melphalan. TNE patients received two
                      additional Isa-KRd cycles postinduction. This prespecified
                      interim analysis (IA) reports the primary end point, MRD
                      negativity (<10-5, next-generation flow), at the end of
                      consolidation. The secondary end point was progression-free
                      survival (PFS).Among 125 patients with HRNDMM
                      (TE-intention-to-treat [ITT]-IA, 99; TNE-ITT, 26) of the IA
                      population for the primary end point, the median age was 58
                      (TE-ITT-IA) and 74 (TNE-ITT) years. Del17p was the most
                      common HRCA (TE, $44.4\%;$ TNE, $42.3\%);$ about one third
                      of evaluable TE/TNE patients presented two or more HRCAs,
                      respectively. The trial met its primary end point with MRD
                      negativity rates after consolidation of $67.7\%$ (TE) and
                      $54.2\%$ (TNE) of patients. Eighty-one of 99 TE-ITT-IA
                      patients reached MRD negativity at any time point
                      $(81.8\%).$ MRD negativity was sustained for ≥1 year in
                      $62.6\%$ of patients. With a median follow-up of 44 (TE) and
                      33 (TNE) months, median PFS was not reached in either
                      arm.Isa-KRd effectively induces high rates of sustainable
                      MRD negativity in the difficult-to-treat HRNDMM population,
                      regardless of transplant status, translating into a median
                      PFS that was not yet reached after 44/33 months.},
      cin          = {C060 / ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331 / I:(DE-He78)ED01-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37753960},
      doi          = {10.1200/JCO.23.01696},
      url          = {https://inrepo02.dkfz.de/record/283173},
}