J Clin Oncol 31, 2013 (suppl; abstr 8509)
Mario Boccadoro, Federica Cavallo, Francesca Maria Gay, Francesco Di Raimondo, Arnon Nagler, Vittorio Montefusco, Francesca Patriarca, Paola Tacchetti, Tommasina Guglielmelli, Pellegrino Musto, Luca Baldini, Claudia Crippa, Marina Ruggeri, Fabiana Gentilini, Maide Cavalli, Dina Ben Yehuda, Tommaso Caravita, Giovannino Ciccone, Izhar Hardan, Antonio Palumbo; Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy; Italian Multiple Myeloma Network, GIMEMA, Italy, Italy; Hematology Division, BMT and Cord Blood Bank, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Hematology Division, Hadassah Medical Center, Jerusalem, Israel; Cancer Epidemiology Unit, CeRMS and CPO Piemonte, Città della Salute e della Scienza, University of Torino, Torino, Italy; Hematology Division, Meir Medical Center, Kfar-Saba, Israel; Division of Hematology, University of Turin, Turin, Italy
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