A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

Inclusion Criteria:

- Histologically-proven mantle cell non-Hodgkin's lymphoma,

- One of the following first-line induction chemotherapy regimens with rituximab: (1)
combination regimen containing all of the following components: cyclophosphamide,
vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen
such as FC (fludarabine, cyclophosphamide)

- Achieved a PR or better response after the first-line induction chemotherapy regimen
(assessed by 2007 Revised Response Criteria for Malignant Lymphoma)

- ECOG performance status score of ≤ 2

- Willing to follow pregnancy precaution

Exclusion Criteria:

- Patients who have received more than 1 line of induction chemotherapy;

- Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are
ineligible;

- Patients who achieved stable disease or progressive disease as best response with
first line-induction chemotherapy;

- Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)

- Platelet count < 60,000/mm^3 (60*10^9/L)

- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0
times upper limit of normal (ULN), except in patients with documented liver
involvement by lymphoma

- Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented
liver involvement by lymphoma

- Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min

- Active or any history of central nervous system (CNS) lymphoma or leptomeningeal
involvement by lymphoma

- Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT
prophylaxis

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)