Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)
filgrastim
+ melphalan
+ bone marrow ablation with stem cell support
Amiloidosis+14
+ Trastornos de las Proteínas Sanguíneas
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1996
Fecha en la que se inscribió al primer participante.OBJECTIVES: Assess overall and progression-free survival following high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with primary amyloidosis. Evaluate the toxic effects associated with this treatment regimen. Evaluate the function of involved organs, especially the heart, lungs, and nervous system, before and after treatment with this regimen. OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1,500 for 3 consecutive days. Patients are followed at 100 days and 1 year post-transplant. PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of abdominal fat, bone marrow, or other target tissues Pathology reviewed by Temple University Amyloidosis secondary to any stage of multiple myeloma allowed provided plasma cell concentration in bone marrow is less than 15% No amyloidosis secondary to rheumatoid arthritis or chronic infection No familial amyloidosis PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: Karnofsky 80-100% Hematopoietic: Not specified Hepatic: Liver function tests less than twice normal No active liver disease Renal: Creatinine clearance greater than 50 mL/min Nephrotic syndrome allowed Cardiovascular: Cardiac evaluation required in patients with left ventricular ejection fraction less than 45% by echocardiogram or MUGA No poorly controlled hypertension Pulmonary: FEV_1 and DLCO greater than 50% of predicted, or pulmonary evaluation required No chronic obstructive pulmonary disease Other: No history of serious coagulopathy, hemorrhage, or bleeding No active infection No other serious comorbid disease (e.g., poorly controlled diabetes) No pregnant women Adequate contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: More than 12 monthly cycles of prior alkylating agent chemotherapy discouraged Endocrine therapy: Corticosteroids discontinued at least 6 weeks prior to transplantation Radiotherapy: No prior radiotherapy Surgery: Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Fox Chase-Temple Cancer Center CCOP Research Base
Philadelphia, United StatesAbrir Fox Chase-Temple Cancer Center CCOP Research Base en Google Maps