A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma

Inclusion Criteria

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