Millennium reports positive results from Phase III study of myeloma drug

Results showed high complete remission (CR) rates of 19% in the Velcade and dexamethasone (VcD) arm as induction therapy and 35% post-transplantation. These high CR rates contributed to 141 patients not requiring a second transplant. In addition, data showed 95% of patients in the VcD arm were alive at one year.

Patients in the VcD arm received four cycles of Velcade at 1.3mg/m2 on days one, four, eight and 11 of a 21-day cycle. Patients also received dexamethasone at 40mg on days one through four during cycles one through four and on days nine through 12 during cycles one and two only. The patients in the vincristine, adriamycin and dexamethasone (VAD) arm were treated for four 28-day cycles with vincristine at 0.4mg/m2 on days one through four; adriamycin at 9mg/m2 on days one through four; and dexamethasone at 40mg on days one through four, days nine through 12 during cycles one through four and on days 17 through 20 during cycles one and two only. Half of the patients in each arm received dexamethasone, cyclophosphamide, etoposide and cisplatinum (DCEP) consolidation pre-transplant. VcD was well tolerated with the incidence of grade 3 and grade 4 adverse events similar in each arm.

Nancy Simonian, chief medical officer of Millennium, said: ” The updated results from the IFM, combined with the pending approval by the FDA, bring us one step further in establishing Velcade as the foundation of therapy for patients with newly diagnosed multiple myeloma.”