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

• Status: Completed
• Trial end date: 2017-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Panobinostat

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