Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

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Dexamethasone

Bortezomib

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Panobinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Panobinostat (PAN \[LBH589\]) is an orally administered pan-deacetylase inhibitor (DACi) belonging to a structurally novel class of compounds deregulating cell proliferation and survival mechanisms of cancer cells.

Novartis Pharmaceuticals

The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or relapsed and refractory multiple myeloma patients who are without satisfactory treatment alternatives prior to the commercial availability\* and reimbursement of panobinostat during the regulatory approval process. This protocol will acquire additional safety data on the use of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be administered in the defined regimen in combination with both BTZ and DEX.

\*(Note: throughout this protocol "commercially available" means local health authority approval and a functional method for reimbursement)

This is an open-label, single arm, multi-center study of oral panobinostat administered in combination with bortezomib and dexamethasone in patients with relapsed, and relapsed and refractory multiple myeloma.

* Panobinostat will be administered in combination with bortezomib and dexamethasone over 2 weeks in each 21 day cycle; the third week will be without administration of any drug.
* Treatment phase 1 will consist of 8, 21 day cycles (24 weeks). Patients with clinical benefit at the end of cycle 8 as per investigator assessment may continue to receive study treatment in phase 2 for a maximum of an additional 24 weeks.
* Patients who have not achieved or maintained at least "no change" (EBMT response criterion) by 8 cycles must discontinue from study treatment
* The protocol will remain open in each participating country until drug is commercially available and reimbursable or until July 2017, whichever comes first (except in Norway where this protocol will end by March 2016).

Dosing schedule for treatment is detailed below:

Treatment Phase 1 (weeks 1-24 starting C1D1)

* PAN given three times per week (TIW), weeks 1 \& 2 of each 3-week cycle (Cycle days 1,3,5,8,10, and 12)
* BTZ given twice a week (BIW) weeks 1 \& 2 of each 3-week cycle (Cycle days 1,4,8, and 11)
* Dex given for 2 days twice a week (BIW), with BTZ on weeks 1 \& 2 of each 3-week cycle (Cycle days 1,2,4,5,8,9,11, and 12)

Treatment Phase 2 (24 weeks starting C9D1)

* PAN given TIW, weeks 1 \& 2 of each 3-week cycle (Cycle days 1,3,5,8,10, and 12)
* BTZ given once a week, weeks 1 \& 2 of each 3 week cycle (Cycle days 1 and 8)
* Dex for 2 days once a week with BTZ, weeks 1 \& 2 of each 3-week cycle (Cycle days 1,2,8, and 9)

An Expanded Treatment Protocol of Panobinostat in Combination Therapy for Relapsed, and Relapsed and Refractory Multiple Myeloma

An Open-label, Multi-center, Expanded Treatment Protocol of Oral Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed, and Relapsed and Refractory Multiple Myeloma

Spots Global Cancer Trial Database for multiple myelome, mm, expanded treatment, panobinostat, bortezomib, dexamethasone, relapsed, refractory, lbh589