Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma
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This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults ≥ 18 years old
Diagnosis of symptomatic multiple myeloma (per IMWG see Kyle et al 2003)
Subjects must have received at least two prior lines of therapy and be refractory to the most recent line of therapy
Subjects must have previously been treated with : bortezomib or lenalidomide
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Patients must have adequate laboratory values
Baseline left ventricular ejection fraction LVEF ≥ the lower limit of the institutional normal
Prior therapy with a histone deacetylase inhibitor (HDAC)
Impaired cardiac function or clinically significant cardiac diseases
Impairment of gastrointestinal function (GI) function or GI disease that may significantly alter the absorption of LBH589
Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Concomitant use of certain medications
Patients who have received chemotherapy, radiation therapy or any investigational drugs, bortezomib or other immunomodulatory therapy or immunotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received steroids ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy.
Patients who have received high-dose corticosteroids as the only component of their most recent line of therapy
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 not using an effective method of birth control.
Other protocol-defined inclusion/exclusion criteria may apply