MedTrace Logo

Study of the Combination of Panobinostat & Carfilzomib in Patients With Relapsed &/or Refractory Multiple Myeloma

NCT01549431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-01-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Panobinostat

Panobinostat will be supplied as 5-mg or 20-mg pink/opaque-colored, hard gelatin capsules. Panobinostat is administered orally three times per week. * Standard 3+3 design * 3 out of 4 weeks

DRUG

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. * Standard 3+3 design * Days 1/2, 8/9 and 15/16 every 4 weeks

DRUG

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.

Sponsors & Collaborators

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • Novartis

    collaborator INDUSTRY

  • Onyx Therapeutics, Inc.

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • University of California, San Francisco

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Jonathan Kaufman, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-02-29
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549431 on ClinicalTrials.gov