A Phase I Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to find out what effects, good and/or bad, the combination of panobinostat and carfilzomib have on the patient's cancer. It will determine the side effects of different dose levels of panobinostat and carfilzomib and determine the best dose and schedule of the two drugs to recommend for future studies. The study will assess the effects of the drug on multiple myeloma. In addition, tests to study the way the drugs work will also be done.
The combination of the 2 drug classes have shown both pre-clinical (studies done in the lab) and clinical (studies done with people) effects against multiple myeloma. For this reason, these 2 drugs are being studied in combination to determine the side effects and anti-myeloma effects of the 2 drugs.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed and/or Refractory Multiple Myeloma|
- the maximum tolerated dose (MTD) of the combination of panobinostat and carfilzomib [ Time Frame: 28 day cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Combination of Panobinostat and Carfilzomib
A cycle of therapy is 4 weeks (28 days in duration). Carfilzomib will be administered Intravenously infusion on days 1, 2 and 8, 9 and 15, 16 of every 28 day cycle. Panobinostat is administered orally three times per week.
standard 3+3 design Oral TIW 3 out of 4 weeksDrug: Carfilzomib
standard 3+3 design
Days 1/2, 8/9 and 15/16 every 4 weeks
Panobinostat will be supplied as 5-mg or 20-mg pink/opaque-colored, hard gelatin capsules.Panobinostat is administered orally three times per week.
Other Name: LBH589Drug: Carfilzomib
Carfilzomib in Cycle 1 will be initiated at 20 mg/m^2 on Days 1 and 2 and escalated to 27mg/m^2 for Days 8, 9, 15, and 16 of Cycle 1 and for the duration of treatment. Carfilzomib will be administered by intravenous infusion on days 1, 2 and 8, 9 and 15, 16 of every 28 day cycle.Drug: Dexamethasone
Dexamethasone (4mg) must be given prior to each carfilzomib infusion during Cycle 1. Dexamethasone pre-dose should continue through Cycle 2 if fever is observed post-dose, Cycle 2 Day 1, or thereafter associated with the infusion of carfilzomib.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549431
|Contact: Jonathan Kaufman, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Todd Zimmerman, MD|
|Principal Investigator:||Jonathan Kaufman, MD||Emory University Winship Cancer Institute|