77
Participants
Start Date
February 18, 2013
Primary Completion Date
February 28, 2019
Study Completion Date
February 28, 2019
Panobinostat
"Induction Therapy (Part A, 21-day cycles): 10 mg by mouth on Days 1, 3, 5, 8, 10, and 12 for 2 weeks with 1 week of rest at the end of each cycle.~Induction Therapy (Part B, 28-day cycles): 10 mg by mouth on Days 1, 3, 5, 15, 17, and 19 of every cycle.~Maintenance dose (Part A, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 8, 10, and 12 of each cycle.~Maintenance dose (Part B, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 15, 17, 19 of each cycle."
Bortezomib
"Induction Therapy (Part A, 21-day cycles): 1.3 mg/m\^2 by vein daily on days 1, 4, 8 and 11 of Cycles 1 - 8.~Induction Therapy (Part B, 28-day cycles): 1.3 mg/m\^2 by vein daily on days 1, 8 and 15 of Cycles 1 - 8."
Lenalidomide
"Induction Therapy (Part A, 21-day cycles): 25 mg by mouth daily on days 1-14 of every cycle.~Induction Therapy (Part B, 28-day cycles): 25 mg by mouth daily on days 1-21 of every cycle.~Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1 - 21 of each cycle."
Dexamethasone
"Induction Therapy (Part A, 21-day cycles): 20 mg by mouth daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of Cycles 1 - 8.~Induction Therapy (Part B, 28-day cycles): 20 mg by mouth daily on Days 1, 2, 8, 9, 15 and 16 of Cycles 1-8.~Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1, 8, 15, 21 of each cycle."
Symptom Questionnaire
Completed on day 1 of each cycle.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Novartis
INDUSTRY
M.D. Anderson Cancer Center
OTHER