Two pivotal phase III trials (MM-009 and MM-010) have demonstrated highly significant improvement of response rates with lenalidomide/dexamethasone compared with placebo/dexamethasone in a total of 704 RMM patients and subsequently led to regulatory approval of lenalidomide in the USA and the EU.
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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.
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