Trial Information

PYRAMID™- A Clinical Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

In this Phase II study sponsored by Millennium Pharmaceuticals Inc, a combination of 5 or 6 drugs will be given to patients who have previously untreated non-Germinal B-Cell like Diffuse large B-Cell Lymphoma to see if the drug combinations are safe and effective. The drugs being studied are VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone. This study will help determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). Up to 190 patients will participate in the study at approximately 50 centers across the United States. Treatment in both arms of the study is scheduled for 6 months and the follow up period is planned for a maximum of 42 additional months.

Inclusion Criteria**:

Male or female patients 18 years of age or older
Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
At least 1 measurable tumor mass.
Availability of paraffin block with sufficient tumor tissue.
No evidence of central nervous system lymphoma.
Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2.
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Exclusion Criteria:

Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
Peripheral neuropathy of Grade 2 or greater.
Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
Active infection requiring systemic therapy.
Major surgery within 2 weeks before first dose.
Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
Myocardial infarction within 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.

** This is a partial listing of the study eligibility criteria. For additional eligibility criteria or information about the study, please contact the research site(s) listed below.

Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-866-VELCADE or email medical@mlnm.com

Hematology Oncology Associates of South Jersey Dr. Lee's Office
Virtua Memorial Hospital Burlington County
175 Madison Avenue
Mount Holly, NJ 08060
Phone: 1-866-VELCADE
Email: medical@mlnm.com

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