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Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients
Date:12/7/2008

(60 percent) and nausea (52 percent).

-- There were no reports of deep-vein thrombosis or pulmonary embolism.

-- As initial therapy, all patients had a partial response or better, with 36% of patients achieveing a CR.

"We are committed to advancing multiple myeloma treatment that delivers the best patient outcomes," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The tolerability of this novel four-drug combination allows us to study its efficacy relative to two of the most active three-drug regimens for previously untreated multiple myeloma patients."

During Phase I, patients received VELCADE at 1.3 mg/m(2) on days 1, 4, 8 and 11 on a 21-day cycle for up to eight cycles; dexamethasone at 40 mg on days 1, 8 and 15; lenalidomide at 15 mg on days 1 through 14; and cyclophosphamide at 100, 200, 300, 400 or 500 mg/m(2) on days 1 and 8 for up to eight 21-day cycles. This was followed by VELCADE at 1.3 mg/m(2) on days 1, 8, 15 and 22 for four 42-day maintenance cycles. The primary endpoint of this Phase I trial was the determination of the maximum tolerated dose of cyclophosphamide in combination with VcDR. The primary endpoints of the ongoing Phase II portion of the trial are complete response and very good partial response rates, while the secondary endpoints include progression-free survival, overall survival, safety and tolerability.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

About VELCADE

VELCADE is co-developed by Mi
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SOURCE Millennium: The Takeda Oncology Company
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