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|
- 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:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Combo of Panobinostat and Carfilzomib
A cycle of therapy is 4 weeks (28 days in duration). Carfilzomib (with dexamethasone during cycle 1) 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.
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 intravenously at 20 mg/m² on Days 1 and 2 and escalated to 27 mg/m² for Days 8, 9, 15, and 16 of Cycle 1 and for the duration of treatment.
Other Name: KyprolisDrug: Dexamethasone
Dexamethasone (4 mg) 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.
Other Name: Decadron
This is a multi-center, open-label, phase I study of panobinostat, carfilzomib in patients with relapsed/refractory multiple myeloma. Based on the preclinical data supporting the use of combined histone de-acetylase (HDAC) and proteasome inhibition, the incidence of single-agent panobinostat and carfilzomib anti-myeloma activity, and clinical data demonstrating safety and efficacy of panobinostat with a different proteasome inhibitor (bortezomib), this study will evaluate the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma in a phase I trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549431
|Contact: Jonathan Kaufman, MDfirstname.lastname@example.org|
|Contact: Kenisha Barronemail@example.com|
|United States, California|
|UCSF-Mount Zion||Not yet recruiting|
|San Francisco, California, United States, 94115|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Kenisha Barron 404-778-5144 firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Todd Zimmerman, MD 773-834-7424 email@example.com|
|Principal Investigator:||Jonathan Kaufman, MD||Emory University Winship Cancer Institute|