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@ARTICLE{Baertsch:125464,
      author       = {M.-A. Baertsch and J. Schlenzka and E. K. Mai and M. Merz
                      and J. Hillengaß and M. S. Raab$^*$ and D. Hose and P.
                      Wuchter and A. D. Ho and A. Jauch and T. Hielscher$^*$ and
                      C. Kunz$^*$ and S. Luntz and S. Klein and I. G. H.
                      Schmidt-Wolf and M. Goerner and M. Schmidt-Hieber and P.
                      Reimer and U. Graeven and R. Fenk and H. Salwender and C.
                      Scheid and A. Nogai and M. Haenel and H. W. Lindemann and H.
                      Martin and R. Noppeney and K. Weisel and H. Goldschmidt},
      title        = {{R}ationale and design of the {G}erman-{S}peaking {M}yeloma
                      {M}ulticenter {G}roup ({GMMG}) trial {R}e{LA}ps{E}: a
                      randomized, open, multicenter phase {III} trial of
                      lenalidomide/dexamethasone versus lenalidomide/dexamethasone
                      plus subsequent autologous stem cell transplantation and
                      lenalidomide maintenance in patients with relapsed multiple
                      myeloma.},
      journal      = {BMC cancer},
      volume       = {16},
      number       = {1},
      issn         = {1471-2407},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2017-01590},
      pages        = {290},
      year         = {2016},
      abstract     = {Despite novel therapeutic agents, most multiple myeloma
                      (MM) patients eventually relapse. Two large phase III trials
                      have shown significantly improved response rates (RR) of
                      lenalidomide/dexamethasone compared with
                      placebo/dexamethasone in relapsed MM (RMM) patients. These
                      results have led to the approval of lenalidomide for RMM
                      patients and lenalidomide/dexamethasone has since become a
                      widely accepted second-line treatment. Furthermore, in RMM
                      patients consolidation with high-dose chemotherapy plus
                      autologous stem cell transplantation has been shown to
                      significantly increase progression free survival (PFS) as
                      compared to cyclophosphamide in a phase III trial. The
                      randomized prospective ReLApsE trial is designed to evaluate
                      PFS after lenalidomide/dexamethasone induction, high-dose
                      chemotherapy consolidation plus autologous stem cell
                      transplantation and lenalidomide maintenance compared with
                      the well-established lenalidomide/dexamethasone regimen in
                      RMM patients.ReLApsE is a randomized, open, multicenter
                      phase III trial in a planned study population of 282 RMM
                      patients. All patients receive three
                      lenalidomide/dexamethasone cycles and--in absence of
                      available stem cells from earlier harvesting--undergo
                      peripheral blood stem cell mobilization and harvesting.
                      Subsequently, patients in arm A continue on consecutive
                      lenalidomide/dexamethasone cycles, patients in arm B undergo
                      high dose chemotherapy plus autologous stem cell
                      transplantation followed by lenalidomide maintenance until
                      discontinuation criteria are met. Therapeutic response is
                      evaluated after the 3(rd) (arm A + B) and the 5(th)
                      lenalidomide/dexamethasone cycle (arm A) or 2 months after
                      autologous stem cell transplantation (arm B) and every 3
                      months thereafter (arm A + B). After finishing the study
                      treatment, patients are followed up for survival and
                      subsequent myeloma therapies. The expected trial duration is
                      6.25 years from first patient in to last patient out. The
                      primary endpoint is PFS, secondary endpoints include overall
                      survival (OS), RR, time to best response and the influence
                      of early versus late salvage high dose chemotherapy plus
                      autologous stem cell transplantation on OS.This phase III
                      trial is designed to evaluate whether high dose chemotherapy
                      plus autologous stem cell transplantation and lenalidomide
                      maintenance after lenalidomide/dexamethasone induction
                      improves PFS compared with the well-established continued
                      lenalidomide/dexamethasone regimen in RMM
                      patients.ISRCTN16345835 (date of registration 2010-08-24).},
      keywords     = {Thalidomide (NLM Chemicals) / Dexamethasone (NLM Chemicals)
                      / lenalidomide (NLM Chemicals)},
      cin          = {G330 / C060},
      ddc          = {610},
      cid          = {I:(DE-He78)G330-20160331 / I:(DE-He78)C060-20160331},
      pnm          = {317 - Translational cancer research (POF3-317)},
      pid          = {G:(DE-HGF)POF3-317},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:27114074},
      pmc          = {pmc:PMC4845347},
      doi          = {10.1186/s12885-016-2321-2},
      url          = {https://inrepo02.dkfz.de/record/125464},
}