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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00532675

Run by

Novartis Pharmaceuticals

People needed

46

Starts

2008-04-22

Expected to finish

2017-11-08

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of active multiple myeloma
• Patients must have received at least one prior line of therapy and their disease has relapsed..
• Patients must be suitable for treatment with lenalidomide \& dexamethasone.
• Adults ≥ 18 years old
• ECOG Performance Status ≤ 2
• Life expectancy > 12 weeks
• Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
• Able to sign informed consent and to comply with the protocol

You may not qualify if…

• Primary refractory MM
• Peripheral neuropathy ≥ CTCAE grade 2
• Impaired cardiac function or clinically significant cardiac diseases
• Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
• Patients with diarrhea > CTCAE grade 1
• Patients using medications that have a relative risk of prolonging the QT interval
• Concomitant use of CYP3A4 inhibitors
• Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment
• Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
• Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy)
• Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.
• Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• 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 — South Brisbane, Queensland, Australia
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Salamanca, Castille and León, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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