Results of two phase III trials for Revlimid (lenalidomide) in multiple myeloma presented at ASH - Celgene

Celgene Corp has announced results from two studies evaluating the investigational use of Revlimid (lenalidomide) maintenance therapy in patients with multiple myeloma. The Myeloma XI trial is a UK-based, large, randomized, open-label phase III study that included a comparison of investigational lenalidomide maintenance treatment versus no maintenance for patients with newly diagnosed multiple myeloma. Overall, the primary endpoint of progression-free survival (PFS) was 36 months for patients receiving lenalidomide (n=857) and 18 months for observation (n=694) in the maintenance phase of the study. For patients 100 days after transplant, median PFS was 50 months for lenalidomide (n=451) and 28 months for observation (n=377). For patients under observation after achieving maximum response, median PFS was 24 months for lenalidomide (n=406) and 11 months for observation (n=317). Grade 3-4 adverse events for patients receiving lenalidomide (n=864) included neutropenia (34%), thrombocytopenia (7%) and anemia (4%).

In the phase III BMT CTN 0702 StaMINA trial, patients 100 days after transplant were randomized following transplant between three arms to receive either 4 cycles of lenalidomide-bortezomib-dexamethasone (RVD) consolidation (ACM) (n=254), tandem melphalan 200mg/m2 autologous stem cell transplant (TAM) consolidation (n=247), or no consolidation (AM) (n=257). At a median follow-up of 38 months, all three arms demonstrated comparable PFS and OS. The addition of RVD consolidation or a second ASCT was not superior to a single ASCT followed by lenalidomide maintenance.

The estimated PFS rates were 57%, 56% and 52% for ACM, TAM and AM arms, respectively (ACM vs TAM p=0.75, ACM vs AM p=0.21, TAM vs AM p=0.37). The estimated overall survival (OS) rates were 86% (95% CI: 80-90%), 82% (95% CI: 76-87%) and 83% (95% CI: 78-88%). Median OS had not been reached. There were 39 cases of SPM reported in 36 patients and the cumulative incidences for first SPM were 6.0%, 5.9% and 4.0% for the ACM, TAM and AM arms, respectively. These studies were presented at the 58th American Society of Hematology (ASH) Annual Meeting.