Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

This research study is for patients who have been diagnosed with Diffuse Large B-cell
Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after
chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called
lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different
subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell
surface marker tests or by gene expression tests. Scientists can look at cells and genes in
the laboratory and see that the two kinds are different, but they don't know yet what the
difference means. To patients and doctors these two kinds seem the same. Right now doctors
don't usually do tests to find out which kind a patient has because the treatment is the same
for both.

This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients
by subtype and then test whether patients taking lenalidomide or any one of four other drugs
have a better response. It is possible that lenalidomide will work better than one of the
other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s)
from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to
test how long patients are disease free on lenalidomide compared to one of the four other
drugs.

On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and
enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013
data cutoff date. According to the Stage 1 results as assessed by the independent response
adjudication committee (IRAC), neither subtype met the pre specified requirement to be
further studied in Stage 2. Additionally, a suitable assay for the selection of participants
for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not
open Stage 2.

Inclusion Criteria:

- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).

- Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab
and an anthracycline, and one additional combination chemotherapy or stem cell
transplant.

- Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining
(MRI).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

- Diagnosis of lymphoma histologies other than DLBCL.

- History of malignancies, other than DLBCL, unless the patient has been disease free
for 3 years or more.

- Eligible for autologous stem cell transplant.

- Known seropositive for, or history of, active human immunodeficiency virus (HIV)
hepatitis B virus (HBV), hepatitis C virus (HCV)

- Neuropathy grade 4.