Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: LBH589

• Registration Number: NCT00532389
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study comprises of a dose-escalation and dose expansion phase and will determine the maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in combination with bortezomib. Safety, tolerability, PK and PD profile of the combined treatments will be assessed as secondary objectives. Dose expansion phase will explore in a non continuous Panobinostat schedule with bortezomib and dexamethasone, safety and tolerability and PK profile of Panobinostat and Bortezomib with and without Dexamethasone

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-20
• Study Start: 2007-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Panobinostat (LBH589)	LBH589	-

Primary Outcome Measures

Name	Time	Method
To determine the MTD of panobinostat with bortezomib	throughout the study

Secondary Outcome Measures

Name	Time	Method
The safety and tolerability of the study continuous Panobinostat treatment in dose escalation phase and non continuous schedule of panobinostat in dose expansion phase	throughtout the study
To characterize the PK profile of bortezomib; the PK profile of panobinostat with and without bortezomib; the PK profile of bortezomib and panobinostat with and without dexamethasone	cycle 1 & cycle 2
To assess the preliminary efficacy of the study treatment	throughout the study

Trial Locations

Locations (5)

Innovative Medical Research of South Florida Dept.ofInnovativeMedResearch; 🇺🇸 Miami Shores, Florida, United States

Dana Farber Cancer Institute Clinical Research Coordinator; 🇺🇸 Boston, Massachusetts, United States

Hackensack University Medical Center Multiple Myeloma Division; 🇺🇸 Hackensack, New Jersey, United States

Swedish Medical Center Dept.ofSwedishMedicalCtr.; 🇺🇸 Seattle, Washington, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Catalunya, Spain