22
Participants
Start Date
August 31, 2009
Primary Completion Date
March 31, 2014
Study Completion Date
March 31, 2014
Bortezomib
Bortezomib 1.3 mg/m\^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.
Rituximab
375 mg/m\^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.
Cyclophosphamide
300 mg/m\^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle
Mesna
600 mg/m\^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.
G-CSF
5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Millennium Pharmaceuticals, Inc.
INDUSTRY
M.D. Anderson Cancer Center
OTHER