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Patients were eligible if they had measurable disease, a platelet count <jats:styled-content>&gt;<\/jats:styled-content>75,000 \u00d7 10<jats:sup>6<\/jats:sup>\/L, an absolute neutrophil count <jats:styled-content>&gt;<\/jats:styled-content>1,000 \u00d7 10<jats:sup>6<\/jats:sup>\/L. Patients received everolimus 10 mg PO daily and were evaluated monthly. A success was defined as a complete or partial response (PR); minor responses (MR) were recorded and considered to be of clinical benefit. Sixty patients were enrolled and treated. The overall response rate (ORR) was 50% (all PR); the clinical benefit rate including MR or better was 73% (95% CI: 60\u201384%) with 23% MR. The median time to response for patients who achieved PR was 2 months (range, 1\u201326). The median duration of response has not been reached and median progression\u2010free survival (PFS) was 21 months. Grade 3 or higher toxicities (at least possibly related to everolimus) were observed in 67% of patients. The most common grade 3 or 4 toxicities were anemia (27%), leukopenia (22%), and thrombocytopenia (20%). Other nonhematological toxicities were diarrhea (5%), fatigue (8%), stomatitis (8%) and pulmonary toxicity (5%). Everolimus has a high single\u2010agent activity of 73% including MR, with a progression free survival of 21 months, indicating that this agent is active in relapsed\/refractory WM. Am. J. 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