Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma

Inclusion Criteria

• •Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
• •Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
• •Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC \> 10 mg/dL provided serum FLC ratio is abnormal
• •Age \>18 years
• •Eastern Cooperative Oncology Group (performance status of ≤20
• •Life expectancy ≥12 weeks
• •Signed written informed consent per institutional and federal regulatory requirements
• •Did not receive chemotherapy (including systemic steroids), immunotherapy (interferon), Imids (thalidomide/lenalidomide), proteasome inhibitors (bortezomib), or radiotherapy for at least 21 days prior to Day 1 of Cycle 1
• •Did not receive any investigational treatment for at least 28 days prior to study entry
• •Absolute granulocyte count of ≥1,000/μL, platelet count ≥50,000/μL, and hemoglobin ≥8.0 g/dL, with no transfusion within the preceding 7 days
• •Adequate liver function defined by a bilirubin value ≤2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ≤2.5 times ULN
• •Adequate renal function defined by a creatinine clearance of ≥30 mL/min
• •Adequate cardiac function defined by a left ventricular ejection fraction (LVEF) ≥40%, QTc \<450 msec, and no evidence of clinically significant dysrhythmias on ECG
• •Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
• •Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry