Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
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|ClinicalTrials.gov Identifier: NCT00089167|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : January 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: filgrastim Drug: dexamethasone Drug: melphalan Drug: thalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||December 2007|
- Overall progression-free survival at 2 years
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|