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 and 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. LONDON: BMC. ISSN 1471-2407

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Abstract

BackgroundDespite 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 (200mg/m(2)), 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.MethodsGMMG-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 2cycles 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.ResultsSince this is the publication of a study protocol of an ongoing study, no results can be presented.DiscussionThis 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 registrationNCT02495922 on June 24th, 2015.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Salwender, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bertsch, UtaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weisel, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duerig, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kunz, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benner, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blau, Igor W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Raab, Marc SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hillengass, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hose, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huhn, StefanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hundemer, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andrulis, MindaugasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jauch, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seidel-Glaetzer, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lindemann, Hans-WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hensel, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fronhoffs, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martens, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hansen, TimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wattad, MohammedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graeven, UllrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Munder, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fenk, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goldschmidt, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-147828
DOI: 10.1186/s12885-019-5600-x
Journal or Publication Title: BMC Cancer
Volume: 19
Date: 2019
Publisher: BMC
Place of Publication: LONDON
ISSN: 1471-2407
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STEM-CELL TRANSPLANTATION; MULTIPLE-MYELOMA; OPEN-LABEL; AUTOLOGOUS TRANSPLANTATION; DEXAMETHASONE COMBINATION; FOLLOW-UP; BORTEZOMIB; THERAPY; SURVIVALMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14782

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