II Study of Arsenic Trioxide in Patients with Multiple Myeloma
determine the rate of response following treatment with Arsenic Trioxide (ATO)
in-patients who have relapsed from or are refractory to conventional therapies
for multiple myeloma.
determine the rates of overall and relapse free survival, the pharmacokinetic
profile of ATO during cycle 1 (in selected patients), and the safety profile of
Confirmed diagnosis of
multiple myeloma of Durie-Salmon stage II or III (i. e., excluding monoclonal
gammopathy, indolent or smoldering myeloma.
Current measurable disease based on serum and urine M protein and/or
History of < or equal to 3 prior treatment regimens (excluding focal
radiation for symptom control). These
prior regimens must have been completed at least 28 days before entry into this
study; and may have included no more than:
3 cytotoxic regimens
1 high-dose cytotoxic regimen as part of stem cell transplant
Age > 18 years.
Karnofsky performance status of at least 70%.
Serum creatinine of <2.5mg/dL.
Serum bilirubin, SGPT, and SGOT < 2 times the upper limit of
Life expectancy > 3 months.
Negative pregnancy test (in women of childbearing potential).
Commitment to use medically acceptable birth control for the duration of
the study (both male and female patients with reproductive potential).
Acceptable concurrent therapies include treatment with erythropoeitin if
part of prior therapy, bisphosphonates (i.e Aredia), and focal radiation for
treatment of disease symptoms.
Criteria( all responses must be “no”
for answers (1-11)
Pregnant or lactating women
Pre-existing neurotoxitity/neuropathy of grade 2 or greater according to
the NCI Common Toxicity Criteria Version 2.
Absolute QT interval >460 msec in the presence of serum potassium and
magnesium values within normal ranges.
Reduced hematology values that are not secondary to multiple myeloma.
Concurrent treatment with cytotoxic chemotherapy, high-dose
corticosteroids, broad field radiation, or any other investigational agents.
Significant cardiac dysfunction
Prior malignancy in the 5 years before treatment in this study.
History of seizures (other than infantile febrile seizures)
Active, serious infections not controlled by antibiotics.
Inability or unwillingness to comply with the treatment protocol.
Patients will undergo EKG, appropriate serum and urine electrophoresis, immuno-typing of serum and urine within 48 hours to 5 days
prior to the first dose of study drug; as well as during various phases of the
Bone marrow exam will be done prior to receiving the first dose (within 5
days), and after cycles 2, 4 and 6.
Patients must have a clearly
detectable and quantifiable monoclonal M- component in the serum or 24-hour
urine collection. Radiologic imaging via MRI or Skeletal survey to document
baseline disease will be done within 28 days prior to the first dose of the
imaging, as clinically indicated, will be repeated every 6 cycles to assess the
progression of lytic lesions if clinically indicated.
Page Last Updated 09/08/2003 05:51:20 PM