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

• Status: Completed
• Trial end date: 2018-12-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Panobinostat

Criteria

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