Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
Data Collection
Immunoglobulin Light-chain Amyloidosis+16
+ Amyloidosis
+ Blood Protein Disorders
Treatment Study
Summary
Study start date: May 1, 2002
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location