Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
busulfan
+ cyclophosphamide
+ allogeneic bone marrow transplantation
Trastornos de las Proteínas Sanguíneas+19
+ Enfermedades de la Médula Ósea
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the efficacy of allogeneic bone marrow transplantation (BMT) following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma, agnogenic myeloid metaplasia, or chronic myelogenous leukemia in first or second chronic phase. Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients. Determine the toxic effects of these preparative regimens in these patients. OUTLINE: Patients are stratified by remission (first vs second vs third). Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1. Allogeneic bone marrow is infused on day 0. Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2. Allogeneic bone marrow is infused on day 0. Patients are followed at days 30 and 90, at 6 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 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 15 a 55 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: Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm^3): Multiple myeloma Agnogenic myeloid metaplasia Chronic myelogenous leukemia in first or second chronic phase Philadelphia chromosome with BCR gene rearrangement Suitable sibling bone marrow donor available PATIENT CHARACTERISTICS: Age: 15 to physiologic 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 2 times normal Alkaline phosphatase less than 2 times normal Renal: Creatinine less than 2 mg/dL Cardiovascular: Ejection fraction normal by MUGA No acute myocardial infarction within the past 6 months No active angina pectoris No active congestive heart failure Pulmonary: FEV greater than 50% predicted DLCO at least 50% Other: HIV negative No active infection No concurrent organ damage or medical problems that would preclude therapy PRIOR CONCURRENT THERAPY: Not specified
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesAbrir Robert H. Lurie Comprehensive Cancer Center at Northwestern University en Google Maps