At a glance
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A Phase II, Single-Center, Open-Label Study Of Oral Panobinostat (LBH589) When Administered In Combination With Lenalidomide And Weekly Dexamethasone In Patients With Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Panobinostat, Lenalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 32 participants across 1 site.
Detailed 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".
Study Details
Timeline
Interventions
Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19.
Each cycle is 28 days. Lenalidomide will be given 25 mg: Days 1-21.
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.