UARK 2009-32 Compassionate Use Study of Carfilzomib (2009-32)
|ClinicalTrials.gov Identifier: NCT00999414|
Recruitment Status : No longer available
First Posted : October 21, 2009
Last Update Posted : October 26, 2015
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: Carfilzomib|
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.
|Study Type :||Expanded Access|
|Official Title:||Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2015|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999414
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, MD, PhD||University of Arkansas|