Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Inclusion Criteria:

• Male or female patients 18 years or older.
• Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).
• At least 1 measurable site of disease.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
• Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

• Prior treatment with VELCADE.
• Prior extended radiotherapy or chemotherapy for lymphoma
• More than 150 mg/m2 of prior doxorubicin
• Major surgery within 3 weeks of study.
• Peripheral neuropathy or neuralgia of Grade 2 or worse.
• Active CNS lymphoma
• Diagnosed or treated for a malignancy other than NHL, with some exceptions
• Pregnant or breast feeding
• Active systemic infection
• Documented of suspected human immunodeficiency virus (HIV)/AIDS
• Uncontrolled or severe cardiovascular disease
• Known allergies, hypersensitivity or intolerance to study drugs
• Serious medical condition that could interfere with study
• Concurrent treatment with another investigational agent