NCT01083602

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

A Phase II, Multi-center, Single Arm, Open Label Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the effectiveness of the combination of Panobinostat plus Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple Myeloma.

Detailed description

This is a phase II, two stage, single arm, open label, multi-center study of oral PAN in combination with BTZ/Dex in patients with relapsed and refractory multiple myeloma, who are bortezomib-refractory and have received at least 2 prior lines of therapy. Patients must have been exposed to an iMID (lenalidomide or thalidomide) and progressed on or within 60 days of their last BTZ-containing line of therapy.

Conditions

• Relapsed and Bortezomib Refractory Multiple Myeloma
• Refractory Multiple Myeloma
• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
DRUG	panobinostat	PAN 20 mg PO given TIW, weeks 1\&2 of each 3-week cycle;• BTZ 1.3 mg/m2 IV push given BIW weeks 1\&2 of each 3 week cycle (days 1,4,8 and 11);• Dex 20 mg PO given QIW, weeks 1\&2 of each 3-week cycle (days 1,2,4,5,8,9,11 and 12)
DRUG	bortezomib
DRUG	dexamethasone

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2010-03-10
• Last updated: 2017-12-21
• Results posted: 2015-03-27

Locations

13 sites across 1 country: United States