The Phase I/II international trial examined the use of single-agent VELCADE in patients with relapsed or refractory systemic AL amyloidosis who required further treatment. The trial was an open-label, non-randomized, dose-escalation study evaluating VELCADE in 70 patients. In the Phase II portion of the trial, 52 patients were treated at the maximum planned dose of 1.6 mg/m2 weekly or 1.3 mg/m2 twice-weekly. Primary and secondary objectives are safety and hematologic response rate, respectively. Donna Reece, M.D., Princess Margaret Hospital, Toronto, Canada, presented the following results:

Hematologic overall response rates (CR+PR), as measured by serum and urine M-protein levels, in the weekly and twice-weekly groups were 69% and 67%; complete response rates were 37% and 24%, respectively More than 76% of patients had a duration of response of one year or longer The rate of serious adverse events (AE) was 44% and 41% and discontinuation due to AEs was 28% and 38% in the weekly and twice-weekly schedules, respectively. The most common AEs ?‰? Grade 3 included fatigue, thrombocytopenia, vomiting, diarrhea and pneumonia. No peripheral neuropathy ?‰? Grade 3 was seen

Fifty-two patients received single-agent VELCADE either weekly>2 on days 1, 8, 15 and 22 of 35-day cycles or twice-weekly>2 on days 1, 4, 8 and 11 of 21-day cycles.

SOURCE Millennium: The Takeda Oncology Company