Panobinostat maintenance in patients with multiple myeloma that have achieved less than complete remission following autologous stem cell transplantation.

Exclusion Criteria42

• Patients with monoclonal gammopathy of uncertain significance (MGUS)
• Patient has been treated with allogeneic transplant
• Patient has received any anti-MM therapy after ASCT including but not limited to:
• chemotherapy prior to start of study
• biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
• radiation therapy
• Patients with progressive MM post-ASCT
• Patient has received prior treatment with DAC in ihibitors including panobinostat
• Patient has received an investigational agent of any kind within 28 days of ASCT
• Patient is taking any anti-cancer therapy concomitantly
• Patient needs valproic acid within 5 days prior to first administration of panobinostat
• Patients with evidence of another malignancy not in remission, or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma,
• or in situ cancer of the cervix)
• Patient has undergone major surgery < 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to < grade 1 CTCAE 4.0 or baseline
• Patient has impaired cardiac function, including any one of the following:
• Left Ventricular Ejection Fraction < the lower limit of institutional norm
• Complete left bundle branch block, bifascicular block
• Obligate use of a permanent cardiac pacemaker
• Congenital long QT syndrome
• History or presence of ventricular tachy-arrhythmias
• Resting bradycardia defined as < 50 bpm
• QTcF > 480 msec on screening ECG
• Any clinically significant ST segment and/or T-wave abnormalities
• Myocardial infarction or unstable angina pectoris < 6 months prior to starting the study drug
• Congestive cardiac failure (New York Heart Association class III-IV)
• Other clinically significant heart disease and vascular disease (eg. uncontrolled hypertension)
• Patient is taking medications with relative risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug
• Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat, such as:
• ulcerative disease
• uncontrolled nausea
• vomiting
• diarrhoea CTCAE 4.0 Grade > 2 (despite antidiarrheal medications)
• malabsorption syndrome
• obstruction
• stomach and/or small bowel resection
• Patient has any other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol such as:
• uncontrolled diabetes
• active or uncontrolled infection
• chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause
• uncontrolled thyroid dysfunction
• recent, acute or active bleeding
• Patient has a known history of human immunodeficiency virus (HIV) seropositivity or history of active/treated hepatitis B or C (a test for screening is not required)