Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: LBH589; Combination Product: Lenalidomide

• Registration Number: NCT00532675
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

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: 2008-04-22
• Primary Completion: 2017-11-08
• Study Completion: 2017-11-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAN 10 mg	LBH589	Panobinostat 10 mg
PAN 25 mg	Lenalidomide	Panobinostat 25 mg
PAN 20 mg	Lenalidomide	Panobinostat 20 mg
PAN 25 mg	LBH589	Panobinostat 25 mg
PAN 5 mg	LBH589	Panobinostat 5 mg
PAN 5 mg	Lenalidomide	Panobinostat 5 mg
PAN 20 mg	LBH589	Panobinostat 20 mg
PAN 10 mg	Lenalidomide	Panobinostat 10 mg

Primary Outcome Measures

Name	Time	Method
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone	24 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment	Da1 to Day 3 (week 1 of first cycle)

Trial Locations

Locations (4)

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.; 🇺🇸 Atlanta, Georgia, United States

St. Vincent's Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Novartis Investigative Site; 🇪🇸 Valencia, Comunidad Valenciana, Spain