Novartis Pharmaceuticals – Multiple Myeloma

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This will be a multi-center, open label, expanded treatment protocol of panobinostat,
bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
Panobinostat will be administered at a starting dose of 20mg orally three times a week
(every other day) for two weeks on and one week off, with dose adjustments permitted based
on observed toxicity. Bortezomib will be administered either intravenously or
sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of
treatment, patients who have achieved stable disease or better by modified EBMT 1998
criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of
a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks)
patients with stable disease or better may continue on therapy at the discretion of their
investigator until September 2015 or until drug is commercially available, whichever comes
first. Patients who have not achieved at least stable disease by 8 cycles must discontinue
from study treatment. Dexamethasone will be administered on the day of and the day
immediately following bortezomib treatment. Patients will not receive any study treatment
during the third week of each cycle. Cycles will be defined as 21 days of treatment.
Investigators may not add any other anti-myeloma agents (with the exception of
bisphosphonates) while patients remain on study treatment. Patients will remain on study
until disease progression, unacceptable toxicity, or end of the study

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