( CR rate of 43 percent. At 38 months 8...)Velcade (bortezomib) for Injection Based Therapies Achieved,Survival Rates as High as 100 Percent in Newly Diagnosed Multiple,Myeloma Patients,Health

Long Term Follow-Up of VcAD (or PAD) for Untreated Multiple Myeloma (Abstract #PO-725)

The open-label Phase I / II study investigated the efficacy of VcAD combination therapy in untreated MM patients. The trial included 40 evaluable patients, who were treated for four cycles prior to SCT. Patients received either VELCADE at 1.3 mg/m(2) (VcAD-1) or 1.0 mg/m(2) (VcAD-2) on days 1, 4, 8 and 11 of a 21-day schedule. Patients also received doxorubicin at 9 mg/m(2) on days 1 through 4 and dexamethasone at 40 mg on days 1 through 4, 8 through 11, and 15 through 18 during cycle one and on days 1 through 4 during cycles two through four. Responses were classified using the EBMT criteria. Results were presented by Rakesh Popat, M.D., St. Bartholomew's Hospital, and showed in the VcAD-1 arm a CR rate of 29 percent prior to SCT, which improved to 57 percent following SCT. At one year, 100 percent of patients were alive with 95 percent of patients alive at two years. Median OS has not yet been reached after four years. Side effects, including peripheral neuropathy, were predictable and manageable, similar to those seen in previous VELCADE clinical trials.

Combination Therapy with VELCADE, DOXIL and Dexamethasone in Newly Diagnosed Myeloma: Updated Results of a Phase II Clinical Trial (Abstract #PO- 721)

The Phase II trial evaluated the efficacy of VDD combination therapy in untreated MM patients. The trial enrolled 40 patients, who received VELCADE at 1.3 mg/m(2) on days 1, 4, 8 and 11 of a 21-day schedule. Patients also received DOXIL at 30 mg/m(2) on day 4 and dexamethasone at 40 mg on days 1 through 4 or 20 mg corresponding with the VELCADE schedule. After four cycles of VDD, patients proceeded to SCT or continued VDD maintenance therapy. Responses were determined based on
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