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Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) plus lenalidomide maintenance or no maintenance in newly diagnosed multiple myeloma (MM) patients.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
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. Clinical trial information: NCT00551928.
|MPR||MEL200||HR (95%CI; p value)||MAINT||No MAINT||HR (95%CI; p value)|
|Median PFS (mos)||25||39||1.66 (1.27-2.18; .0002)||37.5||25.7||0.63 (0.48-0.83;.0008)|
|4-ys OS||71||72||1.08 (0.72-1.63;.71)||76||68||0.68 (0.45-1.04;.08)|
|First randomization||Second randomization|
|Start of maintenance||MPR||MEL200||HR (95%CI;p value)||MAINT||No MAINT||HR (95%CI; p value)|
|Median PFS (mos)||18||41||2.01 (1.45-2.79;<.0001)||41||18||0.50 (0.36-0.69;<.0001)|
|3-ys OS||77||76||0.98 (0.61-1.58;.94)||81||72||0.60 (0.37-0.97;.04)|
Abstracts by M. Boccadoro:
Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) in newly diagnosed multiple myeloma (MM) patients: A phase III trial.Meeting: 2011 ASCO Annual Meeting | Abstract No: 8020
A phase III trial of melphalan/prednisone/lenalidomide (MPR) versus melphalan (200 mg/m2) and autologous transplantation (MEL200) in newly diagnosed myeloma patients.Meeting: 2010 ASCO Annual Meeting | Abstract No: 8015