Carfilzomib, Compassionate Use

Title:   UARK 2009-32 – Compassionate Use Protocol for the Use of Carfilzomib for Patients with Relapsing or Resistant Multiple Myeloma
Sponsor:  UAMS
PI:  Bart Barlogie, MD, PhD 
Phase:   II 
Purpose:  This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma 
Eligibility:  Participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated. Sixty research participants, male or female, age 18 and older, regardless of race or ethnicity, will take part in this study at the Myeloma Institute for Research and Therapy (MIRT).
Treatment:  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 or 36mg/m2) IV bolus to be given at maximum rate of 10ml/minute on Day 8, Day 9. Carfilzomib 27mg/m2 or 36 mg/m2 or 45/mgm2 (given as a 30 minute infusion) on, Day 15 and Day 16 of Cycle 1. Carfilzomib doses of 36 mg/m2 or 45mg/m2 will be given as a 30 minute infusion. 45 mg/m2 dose will be implemented when a subject does not have an adequate Myeloma response (stable, no response, or progressive disease) at the PI’s discretion.  
Contact:   Nathan Petty
E-mail: pettynathanm@uams.edu
Phone: 501-526-6990 ext. 2435