Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myelom...( SAN FRANCISCO Dec. 7 /- Millennium: T...),Health

SAN FRANCISCO, Dec. 7 /PRNewswire/ -- Millennium: The Takeda Oncology Company today reported the Phase I results from a randomized, multi-center, Company-sponsored Phase I/II study of VELCADE, dexamethasone, cyclophosphamide and lenalidomide (VcDCR) in patients with previously untreated multiple myeloma (MM). The preliminary analysis of the safety data showed that the combination of four drugs was generally well tolerated in patients who had received no prior therapies and response rates were encouraging. These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH), held December 5-9, 2008 in San Francisco, California.

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This trial, called EVOLUTION(1), builds on positive results from previous studies of VELCADE based combinations in this setting. The presentation reported the first clinical data with the novel four-drug combination. The safety results allow the trial to proceed to Phase II, which will randomize patients to receive VcDR, VcDC or VcDCR.

Results from the 25 patients treated in this trial with VcDCR for a median of four cycles (range: 2-11 cycles), which were presented by Shaji Kumar, M.D., Mayo Clinic, showed:

-- The maximum tolerated dose of cyclophosphamide in the VcDCR regimen was not reached. The recommended doses for the Phase II portion of the trial include 500 mg/m(2) of cyclophosphamide, the highest planned dose, 1.3 mg/m(2) of VELCADE, 40 mg of dexamethasone and 15 mg of lenalidomide.

-- The only two dose-limiting toxicities reported were febrile neutropenia and reactivation of the Herpes Zoster virus infection.

-- The overall rate of serious adverse events (AEs) was 40 percent. The most common treatment-emergent AEs were constipation (64 percent), fatigue
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