A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant

Inclusion Criteria:

- Male or female patients 18 years or older.

- Diagnosis of mantle cell lymphoma (Stage II, III or IV).

- At least 1 measurable site of disease.

- No prior therapies for mantle cell lymphoma.

- Not eligible for bone marrow transplantation.

Exclusion Criteria:

- Prior treatment with VELCADE.

- Prior anti-neoplastic (including unconjugated therapeutic antibodies), experimental
or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the
treatment of mantle cell lymphoma.

- Major surgery.

- Active systemic infection requiring treatment and patients with known diagnosis of
HIV or active Hepatitis B.

- Peripheral neuropathy or neuropathic pain of Grade 2 or worse.

- Diagnosed or treated for a malignancy other than mantle cell lymphoma (MCL) within 1
year of randomization, or who were previously diagnosed with a malignancy other than
MCL and have any radiographic or biochemical marker evidence of malignancy.