14
Participants
Start Date
May 31, 2012
Primary Completion Date
May 31, 2014
Study Completion Date
May 31, 2014
Lenalidomide
Induction Phase: 25 mg by mouth daily on Days 1-14. Maintenance Phase: at last tolerated dose from Induction Phase day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg.
Bortezomib
"Induction Phase: 1.3 mg/m2 by vein daily on Days 1, 4, 8 and 11.~Maintenance Phase: 1.3 mg/m2 by vein or last tolerated dose on Day 1 and Day 8."
Siltuximab
"Induction Phase Starting Dose: 11 mg/kg by vein on Day 1.~Maintenance Phase: 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy."
Dexamethasone
"Induction Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12.~Maintenance Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. If participant still on Dexamethasone, when entering Maintenance Phase, dose reduced to 20 mg a week."
Questionnaires
M. D. Anderson Symptom Inventory Module (MDASI-MM) completed Day 1, Day 8 of Cycle 1 - 8, and on Day 1 of Cycle 9 and beyond.
University of Texas MD Anderson Cancer Center, Houston
Janssen Services, LLC
INDUSTRY
M.D. Anderson Cancer Center
OTHER