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

Novartis

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Combination Product: Lenalidomide; Drug: LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532675

CLBH589B2206

2006-007030-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

PAN 5 mg

Experimental group

Description:

Panobinostat 5 mg

Treatment:

Combination Product: Lenalidomide

Drug: LBH589

PAN 10 mg

Experimental group

Description:

Panobinostat 10 mg

Treatment:

Combination Product: Lenalidomide

Drug: LBH589

PAN 20 mg

Experimental group

Description:

Panobinostat 20 mg

Treatment:

Combination Product: Lenalidomide

Drug: LBH589

PAN 25 mg

Experimental group

Description:

Panobinostat 25 mg

Treatment:

Combination Product: Lenalidomide

Drug: LBH589