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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

Bärtsch, Marc-Andrea ; Schlenzka, Jana ; Mai, Elias Karl ; Merz, Maximilian ; Hillengaß, Jens ; Raab, Marc S. ; Hose, Dirk ; Wuchter, Patrick ; Ho, Anthony D. ; Jauch, Anna ; Hielscher, Thomas ; Kunz, Christina ; Luntz, Steffen ; Klein, Stefan ; Schmidt-Wolf, Ingo G. H. ; Görner, Martin ; Schmidt-Hieber, Martin ; Reimer, Peter ; Graeven, Ullrich ; Fenk, Roland ; Salwender, Hans ; Scheid, Christof ; Nogai, Axel ; Hänel, Mathias ; Lindemann, Hans W. ; Martin, Hans ; Noppeney, Richard ; Weisel, Katja ; Goldschmidt, Hartmut

In: BMC Cancer, 16 (2016), Nr. 290. pp. 1-10. ISSN 1471-2407

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Download (669kB) | Lizenz: Creative Commons LizenzvertragRationale 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 by Bärtsch, Marc-Andrea ; Schlenzka, Jana ; Mai, Elias Karl ; Merz, Maximilian ; Hillengaß, Jens ; Raab, Marc S. ; Hose, Dirk ; Wuchter, Patrick ; Ho, Anthony D. ; Jauch, Anna ; Hielscher, Thomas ; Kunz, Christina ; Luntz, Steffen ; Klein, Stefan ; Schmidt-Wolf, Ingo G. H. ; Görner, Martin ; Schmidt-Hieber, Martin ; Reimer, Peter ; Graeven, Ullrich ; Fenk, Roland ; Salwender, Hans ; Scheid, Christof ; Nogai, Axel ; Hänel, Mathias ; Lindemann, Hans W. ; Martin, Hans ; Noppeney, Richard ; Weisel, Katja ; Goldschmidt, Hartmut underlies the terms of Creative Commons Attribution 3.0 Germany

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Abstract

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).

Item Type: Article
Journal or Publication Title: BMC Cancer
Volume: 16
Number: 290
Publisher: BioMed Central; Springer
Place of Publication: London; Berlin; Heidelberg
Date Deposited: 26 Apr 2016 08:28
Date: 2016
ISSN: 1471-2407
Page Range: pp. 1-10
Faculties / Institutes: Medizinische Fakultät Mannheim > Medizinische Klinik - Lehrstuhl für Innere Medizin III
Service facilities > German Cancer Research Center (DKFZ)
Medizinische Fakultät Heidelberg > Medizinische Universitäts-Klinik und Poliklinik
Medizinische Fakultät Heidelberg > Institut für Humangenetik
Medizinische Fakultät Heidelberg > Koordinierungszentrum für Klinische Studien
Subjects: 610 Medical sciences Medicine
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