Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
Collecte de données
Amylose par chaîne légère d'immunoglobuline+16
+ Amyloïdose
+ Troubles des Protéines Sanguines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2002
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
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