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
- 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
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
Novartis Investigative Site
🇪🇸Valencia, Comunidad Valenciana, Spain
St. Vincent's Comprehensive Cancer Center
🇺🇸New York, New York, United States