Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy 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

Exclusion Criteria:

- Patients who never achieved at least minor response (MR) to at least one prior line
of therapy

- Clinical spinal cord compression syndromes (unless patient has undergone treatment,
for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1
and patient is off corticosteroids for spinal cord edema or on a stable regimen of <
10 mg/day prednisone equivalent

- Clinical signs of brain involvement or leptomeningeal disease

- Plasma cell leukemia (plasma cells > 2000/cubic mm)

- Women who are pregnant or breast feeding

- Other serious illness or medical condition(s) (see protocol)

- Hypersensitivity to fluphenazine or other phenothiazines

- Currently being treated with hematopoietic growth factors other than erythropoietin
(EPO). Treatment with hematopoietic growth factors may be started during the study
with development, or worsening, of cytopenia

- Concurrent use of anticholinergics

- Concurrent use of phenothiazine and atypical antipsychotics

- Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment
of neuropathy

- Grade 2 or higher persisting prior treatment-related neuropathy

- Concurrent use of systemic steroids with the exception of chronically administered
steroids equivalent to ≤ 10 mg/day prednisone if patient has been on this therapy for
≥1month

- History of seizures or extrapyramidal symptoms

- History of other malignancies within the past 3 years, other than adequately treated
non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other
malignancy is quiescent and medical monitor approval is obtained