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Celgene International Sàrl
today announced results from the
“EMERGE” study (MCL-001), a phase II, multi-center, single-arm trial
evaluating REVLIMID^® (lenalidomide) in patients with previously treated
mantle cell lymphoma (MCL).
In the study, 134 patients who had failed prior treatment with rituximab,
cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib received
25 mg of lenalidomide on days 1-21 of each 28-day cycle. The primary endpoints
of the study were overall response rate and duration of response. Secondary
endpoints included complete response, progression-free survival, time to
progression, overall survival, and safety.
The overall response rate in the study for lenalidomide was 28% (37/134) with
a complete response rate (CR/CRu) of 8% (10/134). The median duration of
response was 16.6 months (95% CI, 7.7-26.7). Additionally, the median
progression-free survival for patients in the study was 4.0 months (95% CI,
3.6-5.6).
The most common grade 3/4 adverse events were neutropenia (43%),
thrombocytopenia (27%), anemia (11%), pneumonia (8%), fatigue (7%), leukopenia
(7%) and febrile neutropenia (7%). Other adverse events included tumor flare
reaction (10%), deep vein thrombosis (4%), pulmonary embolism (2%) and
invasive second primary malignancies (2%).
These data are from an investigational study. REVLIMID® is not approved for
the treatment of mantle cell lymphoma.
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