Table 2.

Treatment-related toxicities observed at different dose levels during cycle 1

Dose level (# Patients)Paclitaxel mg/m2Bortezomib mg/m2Study drug-related toxicities, # EventsDose modification
1 (4)400.7Grade 2 anemia, 210% increment
Grade 2 fatigue, 1
2 (3)450.75≥Grade 2, 014% increment
3 (3)51 (rounded from 51.4 mg/m2)0.86 (rounded from 0.856 mg/m2)≥Grade 2, 012% increment
4 (3)60 (rounded from 58 mg/m2)1.0 (rounded from 0.96 mg/m2)Grade 3 myalgias lasting 7 days before resolution, 14% decrement
Grade 2 anemia, 1
5 (3)60 (rounded from 58 mg/m2)1.0 (rounded from 0.96 mg/m2)Grade 3 anemia, 16.3% decrement
Grade 2 anemia, 1