Multiple Myeloma Clinical Trial
Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Summary
RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in treating patients with primary systemic amyloidosis.
PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Full Description
OBJECTIVES:
Primary
Determine the 2-year and overall progression-free survival of patients with newly diagnosed, previously untreated primary systemic (AL) amyloidosis treated with risk-adapted melphalan followed by thalidomide and dexamethasone.
Secondary
Determine plasma cell disease response in these patients at 3, 12, and 24 months after treatment with this regimen.
Determine amyloid-related disease response in these patients at 12 and 24 months after treatment with this regimen.
Determine the prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL plasma cell clones in patients treated with this regimen.
Determine whether there is molecular minimal residual disease at 12 and 24 months in patients achieving a complete hematologic response after treatment with this regimen.
OUTLINE: Patients are stratified according to the extent of amyloid-related disease (low-risk vs high-risk).
High-risk disease: Patients receive 2 courses of low-dose melphalan IV, dexamethasone, and filgrastim (G-CSF). After 3 months, patients receive thalidomide and dexamethasone if plasma cell disease persists.
Low-risk disease: Patients receive 1 course of high-dose melphalan IV and G-CSF. Patients then receive thalidomide and dexamethasone as in high-risk disease regimen.
Patients are followed at 3, 12, and 24 months.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of primary systemic (AL) amyloidosis within the past 12 months
High- or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
SWOG 0-3
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
Cardiovascular
No New York Heart Association class III or IV congestive heart failure
No restrictive cardiomyopathy requiring oxygen
No myocardial infarction within the past 6 months
No symptomatic cardiac arrhythmia within the past 60 days
Other
No other active malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No prior chemotherapy for AL amyloidosis
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
No other prior or concurrent therapy for AL amyloidosis
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There is 1 Location for this study
New York New York, 10021, United States
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