TY  - JOUR
A1  - Bärtsch, Marc-Andrea
A1  - Schlenzka, Jana
A1  - Mai, Elias K.
A1  - Merz, Maximilian
A1  - Hillengaß, Jens
A1  - Raab, Marc-Steffen
A1  - Hose, Dirk
A1  - Wuchter, Patrick
A1  - Ho, Anthony Dick
A1  - Jauch, Anna
A1  - Hielscher, Thomas
A1  - Kunz, Christina
A1  - Luntz, Steffen
A1  - Klein, Stefan
A1  - Schmidt-Wolf, Ingo Gustav Hermann
A1  - Görner, Martin
A1  - Schmidt-Hieber, Martin
A1  - Reimer, Peter
A1  - Graeven, Ullrich
A1  - Fenk, Roland
A1  - Salwender, Hans
A1  - Scheid, Christof
A1  - Nogai, Axel
A1  - Hänel, Mathias
A1  - Lindemann, Hans-Walter
A1  - Martin, Hans
A1  - Noppeney, Richard
A1  - Weisel, Katja
A1  - Goldschmidt, Hartmut
T1  - Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE : a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantation and lenalidomide maintenance in patients with relapsed multiple myeloma
T2  - BMC cancer
N2  - Background: Despite novel therapeutic agents, most multiple myeloma (MM) patients eventually relapse. Two large phase III trials have shown significantly improved response rates (RR) of lenalidomide/dexamethasone compared with placebo/dexamethasone in relapsed MM (RMM) patients. These results have led to the approval of lenalidomide for RMM patients and lenalidomide/dexamethasone has since become a widely accepted second-line treatment. Furthermore, in RMM patients consolidation with high-dose chemotherapy plus autologous stem cell transplantation has been shown to significantly increase progression free survival (PFS) as compared to cyclophosphamide in a phase III trial. The randomized prospective ReLApsE trial is designed to evaluate PFS after lenalidomide/dexamethasone induction, high-dose chemotherapy consolidation plus autologous stem cell transplantation and lenalidomide maintenance compared with the well-established lenalidomide/dexamethasone regimen in RMM patients.
Methods/Design: ReLApsE is a randomized, open, multicenter phase III trial in a planned study population of 282 RMM patients. All patients receive three lenalidomide/dexamethasone cycles and - in absence of available stem cells from earlier harvesting - undergo peripheral blood stem cell mobilization and harvesting. Subsequently, patients in arm A continue on consecutive lenalidomide/dexamethasone cycles, patients in arm B undergo high dose chemotherapy plus autologous stem cell transplantation followed by lenalidomide maintenance until discontinuation criteria are met. Therapeutic response is evaluated after the 3rd (arm A + B) and the 5th lenalidomide/dexamethasone cycle (arm A) or 2 months after autologous stem cell transplantation (arm B) and every 3 months thereafter (arm A + B). After finishing the study treatment, patients are followed up for survival and subsequent myeloma therapies. The expected trial duration is 6.25 years from first patient in to last patient out. The primary endpoint is PFS, secondary endpoints include overall survival (OS), RR, time to best response and the influence of early versus late salvage high dose chemotherapy plus autologous stem cell transplantation on OS.
Discussion: This phase III trial is designed to evaluate whether high dose chemotherapy plus autologous stem cell transplantation and lenalidomide maintenance after lenalidomide/dexamethasone induction improves PFS compared with the well-established continued lenalidomide/dexamethasone regimen in RMM patients. Trial registration: ISRCTN16345835 (date of registration 2010-08-24).
KW  - Multiple myeloma
KW  - Relapse
KW  - Second-line treatment
KW  - Lenalidomide
KW  - Autologous stem cell transplantation
KW  - High-dose chemotherapy
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/44102
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-441021
SN  - 1471-2407
N1  - Copyright: © Baertsch et al. 2016. Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
VL  - 16
IS  - Art. 290
SP  - 1
EP  - 10
PB  - BioMed Central ; Springer
CY  - London ; Berlin ; Heidelberg
ER  -