Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
primary systemic amyloidosis
Brief 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.
Detailed 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.
Interventions
BIOLOGICALfilgrastim
DRUGdexamethasone
DRUGmelphalan
DRUGthalidomide
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall progression-free survival at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma cell disease response at 3, 12, and 24 months after treatment | — |
| Amyloid-related disease response at 12 and 24 months after treatment | — |
| Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones | — |
| Molecular minimal residual disease at 12 and 24 months | — |
Countries
United States
Outcome results
None listed