arsenic trioxide and dexamethasone in treating patients with recurrent or refractory stage ii or stage iii multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: phase ii trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage ii or stage iii multiple myeloma.

objectives: * determine the response rate of patients with recurrent or refractory stage ii or iii multiple myeloma treated with arsenic trioxide and dexamethasone. * determine the rates of overall and relapse-free survival in patients treated with this regimen. * determine the safety profile of this treatment regimen in these patients. outline: patients receive arsenic trioxide iv daily for 5 days during the first week only and then 2 days a week thereafter. patients also receive iv or oral dexamethasone on days 1-4 every 4 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. disease assessments are conducted every 4 weeks. patients achieving complete response (cr) receive 2 additional courses of therapy after initial determination of cr. final assessments are conducted 4 weeks after the last study treatment and then annually thereafter. projected accrual: a total of 55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of stage ii or iii multiple myeloma * refractory myeloma defined as progressive disease (more than 25% increase in m protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy * no more than 3 prior cytotoxic regimens * no more than 1 prior high-dose cytotoxic regimen with stem cell transplantation * history of disease progression after prior steroid antimyeloma therapy * no smoldering myeloma * measurable disease based on presence of serum and urine m protein and/or measurable plasmacytoma patient characteristics: age: * over 18 performance status: * karnofsky 70-100% life expectancy: * at least 3 months hematopoietic: * absolute granulocyte count greater than 1,200/mm\^3\* * platelet count greater than 75,000/mm\^3\* * hemoglobin greater than 10 g/dl\* note: \*unless due to multiple myeloma hepatic: * bilirubin no greater than 2 times upper limit of normal (uln) * sgot and sgpt no greater than 2 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * absolute qt interval less than 460 msec in the presence of normal potassium and magnesium levels * no significant underlying cardiac dysfunction * no conduction defects * no unstable angina * no congestive heart failure * no new york heart association class ii-iv cardiac disease * no myocardial infarction within the past 6 months other: * no preexisting grade 2 or greater neurotoxicity/neuropathy * no other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * no uncontrolled diabetes mellitus * no active serious infection uncontrolled by antibiotics * no history of grand mal seizures (other than infantile febrile seizures) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see disease characteristics * see chemotherapy * at least 28 days since prior biologic therapy chemotherapy: * see disease characteristics * at least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation * no other concurrent cytotoxic chemotherapy endocrine therapy: * see disease characteristics radiotherapy: * at least 28 days since prior radiotherapy except for focal radiation for symptom control surgery: * not specified

Keywords: refractory multiple myeloma stage ii multiple myeloma stage iii multiple myeloma