NCT02290431

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapse/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	LBH589 (panobinostat)	Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days)
DRUG	bortezomib	Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) \& treatment phase 2 (42 days).
DRUG	dexamethasone	Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days \& treatment phase 2 (42 days)

Timeline

• Start date: 2014-12-16
• Primary completion: 2017-12-29
• Completion: 2018-12-25
• First posted: 2014-11-14
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

20 sites across 1 country: Japan