title: 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
creator: Salwender, Hans
creator: Bertsch, Uta
creator: Weisel, Katja
creator: Duerig, Jan
creator: Kunz, Christina
creator: Benner, Axel
creator: Blau, Igor W.
creator: Raab, Marc Steffen
creator: Hillengass, Jens
creator: Hose, Dirk
creator: Huhn, Stefanie
creator: Hundemer, Michael
creator: Andrulis, Mindaugas
creator: Jauch, Anna
creator: Seidel-Glaetzer, Andrea
creator: Lindemann, Hans-Walter
creator: Hensel, Manfred
creator: Fronhoffs, Stefan
creator: Martens, Uwe
creator: Hansen, Timon
creator: Wattad, Mohammed
creator: Graeven, Ullrich
creator: Munder, Markus
creator: Fenk, Roland
creator: Haenel, Mathias
creator: Scheid, Christof
creator: Goldschmidt, Hartmut
subject: 610
subject: 610 Medical sciences Medicine
description: 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.    Methods: 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.    Results: Since this is the publication of a study protocol of an ongoing study, no results can be presented.    Discussion: 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.    Trial registration:  NCT02495922  on June 24th, 2015.
publisher: BioMed Central ; Springer
date: 2019
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/26512/1/12885_2019_Article_5600.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-265124
identifier:   Salwender, Hans ; Bertsch, Uta ; Weisel, Katja ; Duerig, Jan ; Kunz, Christina ; Benner, Axel ; Blau, Igor W. ; Raab, Marc Steffen ; Hillengass, Jens ; Hose, Dirk ; Huhn, Stefanie ; Hundemer, Michael ; Andrulis, Mindaugas ; Jauch, Anna ; Seidel-Glaetzer, Andrea ; Lindemann, Hans-Walter ; Hensel, Manfred ; Fronhoffs, Stefan ; Martens, Uwe ; Hansen, Timon ; Wattad, Mohammed ; Graeven, Ullrich ; Munder, Markus ; Fenk, Roland ; Haenel, Mathias ; Scheid, Christof ; Goldschmidt, Hartmut  (2019) 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.  BMC Cancer, 19 (504).  pp. 1-11.  ISSN 1471-2407     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/26512/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng