The University of Texas MD Anderson Cancer Center
Houston, TX, USA
NOTE: The IMF did not receive permission to publish either Dr. Weber's slides or the audio of her presentation, so we are bringing you a summary by our medical writer, Lynne Lederman, PhD.
Dr. Weber reported on updated results of two phase III double-blind, randomized trials of lenalidomide plus dexamethasone vs. dexamethasone in North America (MM-009) and Europe, Australia, and Israel (MM-010). Because of the similarity of these trials, data were pooled for analysis. The increased side effect profile in patients with renal dysfunction suggests the need for dose reduction, e.g., from 25 mg daily to 10 mg daily, and to 15 mg every 48 hours in patients with end stage renal disease. Although there was no significant difference between treatment groups in time to progression in the subpopulation of patient who had prior autologous stem cell transplant (SCT), there was increased myelosuppression. In addition to myelosuppression, common side effects included peripheral neuropathy, but to a lesser extent than seen with thalidomide, and thrombotic events (TE), which occurred despite aspirin prophylaxis. Those patients receiving erythropoietic stimulating agents were more likely to have a TE, particularly those taking the combination of lenalidomide plus dexamethasone. Dr. Weber expected the future to bring more combination therapies, trials of novel agents vs. bone marrow transplantation, further examination of deletion 13 and other cytogenetic abnormalities in the setting of different treatment options, and studies on patient quality of life.