Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

A Phase II, Multi-center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.

Inclusion Criteria:

• Patient had a previous diagnosis of multiple myeloma
• Patient required retreatment for multiple myeloma
• Patient had measurable M component in serum or urine at study screening

Exclusion Criteria:

• Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
• Patient who had 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
• Patient received prior treatment with DAC inhibitors including panobinostat
• Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG