Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

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Boccadoro M et al. Proc ASCO 2011;Abstract 8020. Melphalan, Prednisone, Lenalidomide (MPR) versus High Dose Melphalan and Autologous Transplantation (MEL 200) in Newly Diagnosed Multiple Myeloma (MM) Patients: A Phase III Trial Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

R1 R2 Study Design INDUCTION (q4wk x 4) R: 25 mg/d d1-21 d: 40 mg/d d1, 8, 15, 22 All Pts < 65 years old R1 (N = 202) M: 0.18 mg/kg d1-4 P: 2 mg/kg d1-4 R: 10 mg d1-21 q4wk x 6 (N = 200) M: Tandem 200 mg/m2 Stem cell support ASCT R2 No maintenance Relapse R: 10 mg/d d1-21 M = melphalan; P = prednisone; R = lenalidomide; d = low-dose dexamethasone Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

MPR vs MEL200: Response and Survival p-value Response ORR 94% 95% — CR 20% 25% 0.49 >VGPR 60% 58% 0.24 PR 34% 37% Survival 24-month progression-free survival 59% 75% 0.005 24-month overall survival 97% 0.18 Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

MPR vs MEL200: Grade 3-4 Adverse Events MEL200 (n = 143) MPR (n = 130) p < 0.001 p < 0.001 p < 0.001 p < 0.001 p < 0.001 Patients (%) Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

Conclusions First report showing PFS advantage for ASCT in comparison with combinations including novel agents Longer follow-up needed to assess OS No difference in early deaths between MPR and MEL200 Less Grade 3-4 hematologic toxicity with MPR (p < 0.001) Less mucositis and infections with MPR (p < 0.001) Boccadoro M et al. Proc ASCO 2011;Abstract 8020.

Investigator Commentary: A Phase III Study of MPR versus MEL200 in Younger Patients with Newly Diagnosed MM This is the first of 3 studies that will evaluate the role of early versus late transplantation in the context of IMiDs and bortezomib. In this study every patient received induction Rd prior to being randomly assigned to MPR or MEL200. Importantly, this was a well-powered study, with approximately 400 patients. A dramatic improvement in response rate was not observed with MEL200, but a median follow-up approaching 2 years showed a significant improvement in PFS with MEL200. So, after completion of induction therapy, patients receiving MEL200 would have a 1-in-4 chance of having to deal with their disease in 2 years compared to a 1-in-3 chance if they received MPR. This study does not translate completely to the North American experience, in which most patients would likely receive bortezomib as a part of induction therapy, possibly as part of triplet regimen, prior to transplant. Additionally, many patients will receive maintenance therapy. I always advise patients that “transplant is a choice, not a necessity,” but I believe the preponderance of data suggests that early transplantation may be beneficial and certainly does not appear to be deleterious. Sergio Giralt, MD