Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)
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".
Drug: Panobinostat, Lenalidomide and Dexamethasone
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The best overall response rate (ORR) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]The primary endpoint will be the best overall response rate (ORR), including sCR, CR, VGPR, and PR. Subjects will be evaluated for disease response during each cycle and at the End of Study.
- time to progression (TTP) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- duration of response (DOR) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- clinical benefit response (CBR) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- progression free survival (PFS) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
- overall survival (OS) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Panobinostat, Lenalidomide and Dexamethasone
All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.
Drug: Panobinostat, Lenalidomide and Dexamethasone
Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. 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.
Other Name: Panobinostat (LBH589), Lenalidmide (Revlimid), Dexamethasone
The study drug, panobinostat, is made by Novartis Pharmaceuticals Corporation. Panobinostat has not yet been approved by the Food and Drug Administration (FDA) and thus is considered an experimental drug in this research study. Panobinostat is not available to you "on the market" (available for you to buy). It is only available in clinical trials for patients like you with your medical condition. Panobinostat is a drug that may slow down the growth of multiple myeloma or kill multiple myeloma cells by blocking certain enzymes (proteins produced by cells). Panobinostat has shown effects against cancers such as multiple myeloma in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans. As of 31st December 2009, a total of 1116 patients have already received treatment with panobinostat.
Unlike panobinostat, lenalidomide (Revlimid©) and dexamethasone are approved by the FDA and are already available for purchase on the US market. Clinical trials have shown that lenalidomide, especially taken with dexamethasone, produces positive clinical responses with manageable side effects when given to subjects with multiple myeloma.
In this study, subjects will take panobinostat capsules, lenalidomide, and dexamethasone all orally. The purpose of this combination is to interfere with the cancerous cells in multiple and different ways as each of these drugs acts differently on cancer cells. By combining the drugs and giving them at the same time, it might be possible to slow the progression of your disease, rather than if study drugs were given separately. Researchers have combined laboratory studies on animals with this drug combination and the combined effect has been shown to be worthwhile to justify clinical trials in humans.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651039
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Ajai Chari, MD||Icahn School of Medicine at Mount Sinai|