ASH 2013 - Newly Diagnosed Multiple Myeloma

Newly Diagnosed Multiple Myeloma

ASH 2013 Abstract #2: Initial Phase 3 Results of the First (Frontline Investigation Of Lenalidomide + Dexamethasone Versus Standard Thalidomide) Trial (MM-020/IFM 07 01) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Stem Cell Transplantation (SCT). T. Facon et al.

Background: Melphalan, prednisone and thalidomide (MPT) is a standard therapy for NDMM recognized worldwide based on a statistically significant advantage in overall survival (OS) and progression-free survival (PFS) vs. MP (Facon Lancet 2007; Fayers Blood 2011; NCCN 2013). The combination of lenalidomide and low-dose dexamethasone (Rd) increased OS with fewer adverse events (AEs) than treatment with lenalidomide and high-dose dexamethasone in NDMM pts (ECOG E4A03) (Rajkumar Lancet Oncol 2010). The FIRST trial is a multicenter, open-label, phase 3 trial comparing the efficacy and safety of Rd versus MPT in transplant-ineligible NDMM pts.

Conclusions: Continuous treatment with the all oral doublet Rd significantly improved the primary endpoint of PFS compared with the standard triplet, MPT. All secondary endpoints support the clinical benefit of continuous Rd treatment. The safety profile of Rd was manageable, with reduced hematologic SPM compared to MPT. 

This was a very exciting trial with a large number of patients (n = 1,623) enrolled. Anticipation for the results of this trial has been high as there were a number of Canadian centres who participated and with Canada having the second-largest number of patients enrolled. Interim results presented at this meeting revealed that the arm which received lenalidomide with dexamethasone (Rd) until progression is superior to the arm which received melphalan, prednisone and thalidomide combination in terms of progression-free and overall survival. Rd until progression has superior progression-free survival compared to Rd for 18 months but overall survival was not significant at this time. What was reassuring was that that Rd is well tolerated with an acceptable risk of secondary malignancies. These results are strongly suggestive that Rd will become a new standard of treatment for patients with newly diagnosed multiple myeloma who are not transplant eligible although costs of the treatment will remain a factor. Given the size of this trial and the amount of data that has been collected we can anticipate a wealth of information forthcoming from this study in the near future. This will give further insights into how to treat myeloma.
— CARE Hematology Faculty