Multiple Myeloma Clinical Trial
Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
Full Description
OBJECTIVES:
Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide, dexamethasone, and ascorbic acid in patients with relapsed or refractory multiple myeloma.
Determine, preliminarily, the anticancer effects of this regimen in these patients.
Determine the duration of anticancer effects in patients treated with this regimen.
Determine the effect of this regimen on bone and immune function in these patients.
OUTLINE: Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14. Treatment with arsenic trioxide, ascorbic acid, and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone once daily on days 1-4. Treatment with dexamethasone repeats every 28 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma (MM)
Relapsed or refractory disease
Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
Has received ≥ 2 prior treatment regimens for MM
None of the following are allowed:
Non-secretory MM
Plasma cell leukemia
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
PATIENT CHARACTERISTICS:
Age
Over 18
Performance status
ECOG 0-2
Life expectancy
More than 3 months
Hematopoietic
Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if the bone marrow is extensively infiltrated)
Hemoglobin ≥ 8.0 g/dL
Absolute neutrophil count ≥ 1,000/mm^3
Hepatic
AST and ALT < 3.0 times upper limit of normal (ULN)
Bilirubin < 2.0 times ULN
Renal
Not specified
Cardiovascular
No cardiac disease, including any of the following conditions:
History of recurrent supraventricular arrhythmia
History of sustained ventricular tachycardia
History of second or third degree AV block
History of left bundle branch block
Cardiomyopathy with LVEF < 40%
Uncontrolled ischemic heart disease
No myocardial infarction within the past 6 months
No prolonged QT interval > 500 ms
Other
Not pregnant or nursing
Negative pregnancy test
No HIV positivity
No neuropathy > grade 3
Potassium ≥ 4 mEq/L
Magnesium ≥ 1.8 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
More than 30 days since prior investigational drugs
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There is 1 Location for this study
Portland Oregon, 97239, United States
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