Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed multiple myeloma

Advanced disease
Must be refractory to ≥ 2 different methods of standard treatment
Measurable disease, defined as serum paraprotein ≥ 1g/L or urine light chain ≥ 200 mg/24 hours
No brain involvement or leptomeningeal disease

No spinal cord compression unless the following criteria are met:

Patient has undergone prior surgery or radiotherapy
Neurological findings are ≤ grade 1
Patient is off steroids for spinal cord edema or is on a stable regimen of ≤ 10 mg/day of prednisone or equivalent

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if related to skeletal lesions)
Life expectancy ≥ 12 weeks
Absolute granulocyte count ≥ 1,000/mm^3*
Platelet count ≥ 50,000/mm^3*
Hemoglobin ≥ 8.0 g/dL* (no transfusion within the past 7 days)
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN
Creatinine clearance ≥ 30 mL/min
LVEF ≥ 40%
QTc < 450 msec
No evidence of dysrhythmias on EKG
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No congestive heart failure
No angina pectoris
No cardiac arrhythmia
No uncontrolled hypertension, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 105 mm Hg
No myocardial infarction within the past year
No active infection
No HIV, hepatitis B, or hepatitis C infection
No history of psychosis
No history of subcortical brain damage
No hypersensitivity to fluphenazine hydrochloride or other phenothiazines
No history of seizures or extrapyramidal symptoms
No other serious illness or medical condition
No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix NOTE: *Patients with values outside of this range due to infiltration by myeloma may be allowed at the discretion of the investigator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
At least 21 days since prior chemotherapy, immunotherapy, or radiotherapy

At least 21 days since prior and no concurrent systemic steroids

Patients who have been taking chronically administered steroids for ≥ 1 month at a dose ≤ 10 mg/day of prednisone or equivalent are eligible
At least 28 days since prior investigational agents
At least 6 weeks since prior selective serotonin reuptake inhibitors (SSRIs) (a wash-out period equivalent to 5 times the terminal elimination half-life is required for tricyclic antidepressants or norepinephrine reuptake inhibitors)
No concurrent SSRIs, tricyclic antidepressants, or norepinephrine reuptake inhibitors
No concurrent dialysis therapy

No concurrent hematopoietic growth factors except epoetin alfa

Treatment with hematopoietic growth factors may be started during study if patient develops or has progressive cytopenia
No concurrent anticholinergics or other antipsychotics
No concurrent antiseizure drugs except Neurontin for treatment of neuropathy