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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.
Efficacy and safety of REVLIMID were evaluated in the MCL clinical trial1
Trial design highlights:
MCL Trial.
- A multicenter, single-arm, single-agent, open-label study
- Patients received REVLIMID 25 mga once daily for 21 days every 28 days
- Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent
Key Inclusion Criteria.b
- Biopsy-proven MCL with measurable disease by CT scan
- Disease that is relapsedc after or refractoryd to bortezomib or a bortezomib-containing regimene
- Creatinine clearance ≥30 mL/mina
Efficacy Endpoints.
- Overall response rate (ORR)f,g
- Duration of response (DOR)f,h
Other Endpoints Included.
- Time to response (TTR)f
aPatients with creatinine clearance (CrCl) ≥60 mL/min; patients with CrCl ≥30 mL/min and <60 mL/min were given REVLIMID 10 mg once daily for 21 days every 28 days.
bAdditional inclusion and exclusion criteria apply.
cDefined as progression within 1 year after treatment with bortezomib or a bortezomib-containing regimen.
dDefined as without any response of partial response (PR) or better during treatment with bortezomib or bortezomib-containing regimen.
eHad received prior treatment with anthracycline or mitoxantrone, cyclophosphamide, rituximab, and bortezomib, alone or in combination.
fBased on all evaluable patients who received ≥1 dose of REVLIMID.
gBased on review of radiographic scans by an independent review committee, according to a modified version of the International Workshop Lymphoma Response Criteria (Cheson, 1999); ORR was defined as: CR + CRu + PR.
hThe DOR is defined as the time from the initial response (at least PR) to documented disease progression.
REVLIMID was studied in previously treated patients with relapsed or
refractory disease.1
See Patient Demographics
