TY  - JOUR
PB  - BioMed Central ; Springer
KW  - Multiple myeloma
KW  -  elotuzumab
KW  -  autologous stem cell transplant
KW  -  high-dose chemotherapy
A1  - Salwender, Hans
A1  - Bertsch, Uta
A1  - Weisel, Katja
A1  - Duerig, Jan
A1  - Kunz, Christina
A1  - Benner, Axel
A1  - Blau, Igor W.
A1  - Raab, Marc Steffen
A1  - Hillengass, Jens
A1  - Hose, Dirk
A1  - Huhn, Stefanie
A1  - Hundemer, Michael
A1  - Andrulis, Mindaugas
A1  - Jauch, Anna
A1  - Seidel-Glaetzer, Andrea
A1  - Lindemann, Hans-Walter
A1  - Hensel, Manfred
A1  - Fronhoffs, Stefan
A1  - Martens, Uwe
A1  - Hansen, Timon
A1  - Wattad, Mohammed
A1  - Graeven, Ullrich
A1  - Munder, Markus
A1  - Fenk, Roland
A1  - Haenel, Mathias
A1  - Scheid, Christof
A1  - Goldschmidt, Hartmut
TI  - 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
IS  - 504
SP  - 1
AV  - public
N2  - 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.
CY  - London ; Berlin, Heidelberg
VL  - 19
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/26512/
SN  - 1471-2407
JF  - BMC Cancer
ID  - heidok26512
Y1  - 2019///
EP  - 11
ER  -