Lenalidomide (Revlimid) Plus Dexamethasone Compared with Dexamethasone Alone in Patients with Newly Diagnosed Multiple Myeloma

Clinical Trial Reports from ASCO

In an oral presentation, Jeffrey A. Zonder, MD, Division of Hematology-Oncology, Karmanos Cancer Center, Wayne State University School of Medicine, Detroit, Michigan, reported updated results of SWOG 0232, a study of lenalidomide (Revlimid) plus dexamethasone compared with dexamethasone alone in patients with newly diagnosed multiple myeloma (MM).

Highlighted in the presentation was a combined complete response (CR) rate plus very good partial response (VGPR) rate of 62% for lenalidomide plus dexamethasone, compared with 19% for dexamethasone alone (P <.002). In addition, patients in the lenalidomide plus dexamethasone arm of the study had a progression-free survival rate of 77% after one year, compared with 55% for dexamethasone alone (P = .002). At one year, overall survival for patients in the lenalidomide plus dexamethasone arm was 93%, compared with 91% for dexamethasone alone. These data were confounded by the fact that patients in the dexamethasone-alone arm were given the option to cross over into the lenalidomide plus dexamethasone- arm after the study was halted early.

Grade 3/4 adverse events were more frequent in patients with MM who received the combination of lenalidomide-plus dexamethasone compared with dexamethasone alone. Neutropenia (13.8% vs 2.4%) and infections (18.9% vs 9.8%) were the most frequently reported adverse events. Deep vein thrombosis occurred in 27% of patients receiving lenalidomide plus dexamethasone, compared with 14.6% in those receiving dexamethasone alone.