Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
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.
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.
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