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

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)