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
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 ap...
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| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
25 April 2016
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| In: |
BMC cancer
Year: 2016, Volume: 16 |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/s12885-016-2321-2 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s12885-016-2321-2 Verlag, kostenfrei, Volltext: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-016-2321-2 
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| Author Notes: | Marc-Andrea Baertsch, Jana Schlenzka, Elias K. Mai, Maximilian Merz, Jens Hillengaß, Marc S. Raab, Dirk Hose, Patrick Wuchter, Anthony D. Ho, Anna Jauch, Thomas Hielscher, Christina Kunz, Steffen Luntz, Stefan Klein, Ingo G.H. Schmidt-Wolf, Martin Goerner, Martin Schmidt-Hieber, Peter Reimer, Ullrich Graeven, Roland Fenk, Hans Salwender, Christof Scheid, Axel Nogai, Mathias Haenel, Hans W. Lindemann, Hans Martin, Richard Noppeney, Katja Weisel and Hartmut Goldschmidt |
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| 245 | 1 | 0 | |a Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE |b 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 |c Marc-Andrea Baertsch, Jana Schlenzka, Elias K. Mai, Maximilian Merz, Jens Hillengaß, Marc S. Raab, Dirk Hose, Patrick Wuchter, Anthony D. Ho, Anna Jauch, Thomas Hielscher, Christina Kunz, Steffen Luntz, Stefan Klein, Ingo G.H. Schmidt-Wolf, Martin Goerner, Martin Schmidt-Hieber, Peter Reimer, Ullrich Graeven, Roland Fenk, Hans Salwender, Christof Scheid, Axel Nogai, Mathias Haenel, Hans W. Lindemann, Hans Martin, Richard Noppeney, Katja Weisel and Hartmut Goldschmidt |
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| 520 | |a 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. | ||
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