Multiple Myeloma Clinical Trial
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 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".
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.
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