Compassionate Use Study of Carfilzomib (2009-32)
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma|
- prevent CMV [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Carfilzomib (20mg/m2) IV push to be given at maximum rate of 10ml/minute on Days 1 and Day 2 of Cycle 1 only.
Carfilzomib (27mg/m2) IV bolus to be given at maximum rate of 10ml/minute on Day 8, 9, 15, and 16 of Cycle 1, then through Cycle 2 and beyond if initial dosing with 20mg/m2 tolerated.
For patients who tolerated 27mg/m2 through cycle 2 Days 1 and 2, Carfilzomib dose may be escalated to 36mg/m2 on days 8, 9, 15 and 16 of cycle 2. If tolerated, subsequent cycles will utilize 36mg/m2.
The protocol has been designed for relapsing or refractory multiple myeloma patients. A maximum of 30 patients may be treated on this protocol.
Since this is a compassionate use study of an investigational agent, the size is determined by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment and accrual number will be limited to N=30.
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, MD, PhD||University of Arkansas|