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news.Celgene International Sarl has reported early evidence of efficacy from a Phase I/II study evaluating lenalidomide with rituximab for the treatment of relapsed/refractory mantle cell lymphoma. The study indicated that 70% of patients achieved responses with 30% of patients achieving complete responses when given the combination therapy.
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The data presented showed that seven out of ten patients achieved responses including three complete remissions (30%), four partial remissions (40%), one patient with stable disease, and two patients with progressive disease. The most common grade 3/4 adverse events observed were neutropenia, febrile neutropenia, thrombocytopenia and myalgia.
18 patients were involved in the trial, all of whom had previously been treated with rituximab, and were given lenalidomide daily for the first 21 days of a 28 day cycle and rituximab (375mg/m2) by IV infusion weekly for four weeks only during the first cycle with the first dose on day 1 in cycle 1. A standard dose escalation was used to determine that the maximum tolerated dose of lenalidomide was 20mg.
Revlimid is approved for use as an oral treatment in multiple myeloma in combination with dexamethasone by the European Medicines Agency.