An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
SCIO-469
+ SCIO-469 and bortezomib
Trastornos de las Proteínas Sanguíneas+9
+ Enfermedades Cardiovasculares
+ Trastornos Hemorrágicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 2004
Fecha en la que se inscribió al primer participante.The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 62 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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.A partir de 18 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
Inclusion Criteria: * Life expectancy more than three months * diagnosed with multiple myeloma (MM) * relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy * Karnofsky performance status = 60 * no electrocardiographic evidence of acute ischemia or new conduction system abnormalities * no history of myocardial infarction within last 6 months * serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN) * total serum bilirubin = 2X ULN * Calculated or measured creatinine clearance \>30 mL/min * platelet count = 30 x 10(9)/L * hemoglobin concentration = 8 g/dL * white blood cell count = 2.0 x 10(9)/L Exclusion Criteria: * Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes) * major surgery within four weeks of enrollment * severe elevated serum calcium * heart failure * receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents * receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment * known allergies to agents used in bortezomib (e.g., boron or mannitol) * poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios