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| |  Neutropenia Not a Barrier to Long-Term Lenalidomide/Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma: Presented at ASH By Betty S. Riggs NEW ORLEANS -- December 7, 2009 -- In patients with relapsed/refractory multiple myeloma treated with lenalidomide plus dexamethasone, half experience their highest grade of neutropenia early -- within the first 6 months -- according to a study presented here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. Sagar Lonial, MD, Emory University School of Medicine, Atlanta, Georgia, reported the findings on December 6. Because neutropenia is one of the most common haematological events occurring in patients treated with lenalidomide and dexamethasone, the investigators evaluated the incidence, onset, duration, and severity of neutropenic events in patients with relapsed/refractory multiple myeloma receiving long-term therapy with the combination. They pooled data from 2 randomised, double-blind, placebo-controlled, phase 3 trials (MM-009 [n = 353] and MM-010 [n = 351]); 353 patients were included in this subanalysis. Overall, 46% (n = 164) of patients experienced a neutropenic event of any grade at some point during the course of the study, with 52% and 76% of patients experiencing their most severe event within 6 and 12 months of therapy, respectively. Only 24% of patients who experienced neutropenia experienced their highest grade of event after 12 months of therapy. The median duration of neutropenia overall was 10 days. Sixty percent of patients who experienced a neutropenic event had more than 1 event. A grade 3 or 4 event occurred in 137 (39%) patients, with the majority being grade 3. Of these, 65% (n = 89) received granulocyte-colony stimulating factor (G-CSF) during treatment with lenalidomide and dexamethasone. Febrile neutropenia was less common with 11 (3%) patients reporting 12 events. Of these, 7 experienced their first febrile neutropenic event within the first 6 months. Only 3.3% (n = 12) of patients discontinued treatment due to a neutropenic event, and the median time to discontinuation was 7 months. A mean baseline absolute neutrophil count (SD) of 2.78 x 103/µL (1.22) was the only significant factor predictive of developing grade 3/4 neutropenic events during the lenalidomide/dexamethasone treatment period. The prior number of therapies was not a significant predictor. Overall, the incidence, duration, and severity of neutropenic events did not change over time during therapy. These data demonstrate the predictable safety profile of lenalidomide plus dexamethasone and support the long-term use of this combination therapy in patients with relapsed/refractory multiple myeloma. The study was supported by the Celgene Corporation. [Abstract title: Neutropenia Is a Predictable and Early Event in Affected Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide in Combination With Dexamethasone. Abstract 2879]
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