Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00089167


Primary Contact:

Principal Investigator
Raymond L. Comenzo, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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