drugset / Trial / NCT01651039

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

NCT01651039

Phase 2 Completed 32 enrolled Ajai Chari Novartis Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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".

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Panobinostat Small molecule 20 mg Oral

Indications