Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089167
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2004-08-04
Brief Title:
Melphalan Thalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Previously Untreated Primary Systemic Amyloidosis
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-02031 | None | None | None |