eprintid: 26512
rev_number: 14
eprint_status: archive
userid: 1589
dir: disk0/00/02/65/12
datestamp: 2019-08-06 12:45:08
lastmod: 2019-08-22 10:13:51
status_changed: 2019-08-06 12:45:08
type: article
metadata_visibility: show
creators_name: Salwender, Hans
creators_name: Bertsch, Uta
creators_name: Weisel, Katja
creators_name: Duerig, Jan
creators_name: Kunz, Christina
creators_name: Benner, Axel
creators_name: Blau, Igor W.
creators_name: Raab, Marc Steffen
creators_name: Hillengass, Jens
creators_name: Hose, Dirk
creators_name: Huhn, Stefanie
creators_name: Hundemer, Michael
creators_name: Andrulis, Mindaugas
creators_name: Jauch, Anna
creators_name: Seidel-Glaetzer, Andrea
creators_name: Lindemann, Hans-Walter
creators_name: Hensel, Manfred
creators_name: Fronhoffs, Stefan
creators_name: Martens, Uwe
creators_name: Hansen, Timon
creators_name: Wattad, Mohammed
creators_name: Graeven, Ullrich
creators_name: Munder, Markus
creators_name: Fenk, Roland
creators_name: Haenel, Mathias
creators_name: Scheid, Christof
creators_name: Goldschmidt, Hartmut
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
subjects: 610
divisions: 850300
divisions: 911500
divisions: 913000
keywords: Multiple myeloma, elotuzumab, autologous stem cell transplant, high-dose chemotherapy
abstract: 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.
date: 2019
publisher: BioMed Central ; Springer
id_scheme: DOI
ppn_swb: 1671852923
own_urn: urn:nbn:de:bsz:16-heidok-265124
language: eng
bibsort: SALWENDERHRATIONALEA2019
full_text_status: public
publication: BMC Cancer
volume: 19
number: 504
place_of_pub: London ; Berlin, Heidelberg
pagerange: 1-11
issn: 1471-2407
citation:   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     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/26512/1/12885_2019_Article_5600.pdf