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Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)

NCT01651039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-04-09

Study results available
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Summary

The purpose of this clinical research study is to find out the effects of a drug called panobinostat (LBH589) when given to people like you with multiple myeloma in combination with the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will also be studied. Your physical state, changes in the state of your multiple myeloma, and laboratory findings taken while on-study will help us decide if panobinostat combined with dexamethasone and lenalidomide is safe and effective.

This goal of this study therefore is to determine the activity of the combination of panobinostat thrice weekly every other week, lenalidomide, and weekly dexamethasone in a similar group of subjects. The doses of lenalidomide and dexamethasone will be that which is approved by the FDA for multiple myeloma and you will take each drug at a specific frequency over a 4 week (28 day) period. This period is called a "study cycle".

Conditions

Interventions

DRUG

Panobinostat

Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19.

DRUG

Lenalidomide

Each cycle is 28 days. Lenalidomide will be given 25 mg: Days 1-21.

DRUG

Dexamethasone

Each cycle is 28 days. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.

Sponsors & Collaborators

Principal Investigators

  • Ajai Chari, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-12-21
Completion
2016-12-21

Countries

  • United States

Study Locations

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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 NCT01651039 on ClinicalTrials.gov