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Background: The incorporation of new drugs into induction,consolidation,and maintenance therapy is changing the treatment paradigm of MM.Methods: At diagnosis,402 pts(< 65 years)were randomly assigned to receive six MPR cycles(N=202)or tandem MEL200(N=200).After MPR or MEL200,pts were further randomized,within each group,for no maintenance(N=204)or lenalidomide maintenance(N=198).A 2x2 factorial randomized trial was designed.The primary end point was PFS.An enrolment of 170 pts/arm was required to demonstrate a 15%improvement of PFS at 2 years(2-sides a = 0.05,1-β 80%).Results: After a median follow-up of 45 mos from diagnosis,the median PFS was 25 mos with MPR and 39 mos with MEL200(p=.0002).Median PFS were 37.5 mos for maintenance and 25.7 mos for no maintenance(p=.0008).The 4-year OS from diagnosis was 71%with MPR and 72%with MEL200(p=0.71),76%for maintenance and 68%for no maintenance(p=.08).After a median follow-up of 32 mos from start of maintenance,the median PFS was for 41 mos for maintenance and 18 mos for no maintenance(p<.0001).The 3-year OS from start of maintenance was 81%for maintenance and 72%for no maintenance(p=.04).Conclusions: MEL200 significantly prolonged PFS in comparison with MPR.Lenalidomide maintenance significantly reduced the risk of progression independently from the previous treatment.OS is similar between MPR and MEL200,with a trend for an improved OS in pts receiving lenalidomide as maintenance therapy.