Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00089167
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall progression-free survival at 2 years
- Secondary Outcome Measures
Name Time Method Amyloid-related disease response at 12 and 24 months after treatment Plasma cell disease response at 3, 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
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States