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REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
The efficacy and safety of REVLIMID were evaluated in a multicenter, single-arm, single-agent, open-label clinical trial (N=134). The patient population relapsed after bortezomib or a bortezomib-containing regimen, or were refractory to bortezomib or a bortezomib-containing regimen before entering the trial. The efficacy end points were overall response rate (ORR) and duration of response (DOR). Other end points included time to response (TTR).