Spots Global Cancer Trial Database for Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma
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Trial Identification
Brief Title: Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma
Official Title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Bortezomib in Adult Patients With Multiple Myeloma
Study ID: NCT00532389
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Canberra, Australian Capital Territory, Australia
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, München, , Germany
Novartis Investigative Site, Wuerzburg, , Germany
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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