<> "The repository administrator has not yet configured an RDF license."^^ . <> . . . "Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma"^^ . "Background: 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.\r\n\r\nMethods: 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.\r\n\r\nResults: Since this is the publication of a study protocol of an ongoing study, no results can be presented.\r\n\r\nDiscussion: 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.\r\n\r\nTrial registration: NCT02495922 on June 24th, 2015."^^ . "2019" . . "19" . "504" . . "BioMed Central ; Springer"^^ . . . "BMC Cancer"^^ . . . "14712407" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "Hans"^^ . "Salwender"^^ . "Hans Salwender"^^ . . "Anna"^^ . "Jauch"^^ . "Anna Jauch"^^ . . "Andrea"^^ . "Seidel-Glaetzer"^^ . "Andrea Seidel-Glaetzer"^^ . . "Timon"^^ . "Hansen"^^ . "Timon Hansen"^^ . . "Roland"^^ . "Fenk"^^ . "Roland Fenk"^^ . . "Stefanie"^^ . "Huhn"^^ . "Stefanie Huhn"^^ . . "Katja"^^ . "Weisel"^^ . "Katja Weisel"^^ . . "Ullrich"^^ . "Graeven"^^ . "Ullrich Graeven"^^ . . "Hans-Walter"^^ . "Lindemann"^^ . "Hans-Walter Lindemann"^^ . . "Manfred"^^ . "Hensel"^^ . "Manfred Hensel"^^ . . "Stefan"^^ . "Fronhoffs"^^ . "Stefan Fronhoffs"^^ . . "Axel"^^ . "Benner"^^ . "Axel Benner"^^ . . "Hartmut"^^ . "Goldschmidt"^^ . "Hartmut Goldschmidt"^^ . . "Mathias"^^ . "Haenel"^^ . "Mathias Haenel"^^ . . "Christof"^^ . "Scheid"^^ . "Christof Scheid"^^ . . "Marc Steffen"^^ . "Raab"^^ . "Marc Steffen Raab"^^ . . "Jan"^^ . "Duerig"^^ . "Jan Duerig"^^ . . "Uta"^^ . "Bertsch"^^ . "Uta Bertsch"^^ . . "Christina"^^ . "Kunz"^^ . "Christina Kunz"^^ . . "Markus"^^ . "Munder"^^ . "Markus Munder"^^ . . "Dirk"^^ . "Hose"^^ . "Dirk Hose"^^ . . "Igor W."^^ . "Blau"^^ . "Igor W. Blau"^^ . . "Mohammed"^^ . "Wattad"^^ . "Mohammed Wattad"^^ . . "Uwe"^^ . "Martens"^^ . "Uwe Martens"^^ . . "Michael"^^ . "Hundemer"^^ . "Michael Hundemer"^^ . . "Jens"^^ . "Hillengass"^^ . "Jens Hillengass"^^ . . "Mindaugas"^^ . "Andrulis"^^ . "Mindaugas Andrulis"^^ . . . . . . "Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma (PDF)"^^ . . . "12885_2019_Article_5600.pdf"^^ . . . "Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma (Other)"^^ . . . . . . "indexcodes.txt"^^ . . "HTML Summary of #26512 \n\nRationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma\n\n" . "text/html" . . . "610 Medizin"@de . "610 Medical sciences Medicine"@en . .