Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2009
End Date:July 2015

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A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of
HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded
protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease
inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated
synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore,
clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat
and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and
manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously
treated and relapsed MM, the purpose of this prospective, multinational, randomized,
double-blind, placebo-controlled, parallel group Phase III study is to compare the results
in progression-free survival of 2 combination therapies, panobinostat with bortezomib and
dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously
treated MM whose disease has recurred or progressed.


Inclusion Criteria:

1. Patient has a previous diagnosis of multiple myeloma.

2. Patient requires retreatment for multiple myeloma

3. Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

1. Patient who has progressed under all prior lines of anti MM therapy

2. Patient who has been treated by bortezomib before, and did not reach at least a minor
response under this therapy, or progressed under it or within 60 days of last dose

3. Patient has shown intolerance to bortezomib or to dexamethasone or components of
these drugs or has any contraindication to one or the other drug , following locally
applicable prescribing information

4. Patient received prior treatment with DAC inhibitors including panobinostat

5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG

6. Patient taking medications with relative risk of prolonging the QT interval or
inducing Torsade de pointes

7. Female patient who is pregnant or breast feeding or with childbearing potential and
not willing to use a double method of contraception up to 3 months after the end of
study treatment. Male patient who is not willing to use a barrier method of
contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
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Marywood, Illinois 60153
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601 N. 5th Street
Bismarck, North Dakota 58501
701-751-1128
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3918 Via Poinciana # 1
Lake Worth, Florida 33467
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Amarillo, Texas 79106
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Anaheim, California 92801
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Boca Raton, Florida 33486
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Concord, California 94520
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3123 Research Boulevard Suite 150
Dayton, Ohio 45420
(937) 775-1350
Dayton CCOP We are a regional non-profit cancer research consortium serving the Miami Valley area...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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East Orange, New Jersey 07018
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East Providence, Rhode Island 02915
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Kennewick, Washington 99336
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La Plata, Buenos Aires
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Los Angeles, California 90027
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Middletown, Ohio 45042
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Mt. Kisco, New York 10549
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Nashville, Tennessee 37232
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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Quincy, Illinois 62301
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Rockville, Maryland 20850
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San Diego, California 92120
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Seattle, Washington 98104
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Walla Walla, Washington 99362
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