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In September 2014 the results from a double-blind, multi-center, phase 3 trial (MM-015), comparing melphalan–prednisone–lenalidomide induction therapy, followed by lenalidomide maintenance therapy (MPR-R), with melphalan–prednisone–lenalidomide (MPR) or melphalan–prednisone (MP) followed by placebo, were published in the New England Journal of Medicine. Patients who were 65 years of age or older with Newly Diagnosed Multiple Myeloma (NDMM) and ineligible for stem-cell transplantation, were recruited from February 2007 to September 2008. The primary endpoint was progression-free survival (PFS) and the primary comparison was between MPR and MP; secondary endpoints included overall survival (OS) (although the study was not specifically empowered to assess OS), as well as response rate, time to response, duration of response and safety profile.
This study indicated that the use of lenalidomide in both the induction treatment phase, as well as the maintenance phase, was highly effective; in particular, lenalidomide maintenance was associated with higher PFS regardless of age, and had a favourable safety profile. However, the use of lenalidomide in the induction phase only conferred benefits to patients aged 65-75. Consequently, lenalidomide maintenance therapy was approved for use in patients with NDMM ineligible for transplantation by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), following this trial.
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