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.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis|
- Overall progression-free survival at 2 years [ Designated as safety issue: No ]
- Plasma cell disease response at 3, 12, and 24 months after treatment [ Designated as safety issue: No ]
- Amyloid-related disease response at 12 and 24 months after treatment [ Designated as safety issue: No ]
- Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones [ Designated as safety issue: No ]
- Molecular minimal residual disease at 12 and 24 months [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089167
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Raymond L. Comenzo, MD||Memorial Sloan Kettering Cancer Center.|
|Principal Investigator:||Madhav Dhodapkar, MD||Memorial Sloan Kettering Cancer Center.|