A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
cyclophosphamide
+ dexamethasone
+ idarubicin
Trastornos de las Proteínas Sanguíneas+10
+ Enfermedades Cardiovasculares
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the response rate, response duration, and survival of patients with relapsed multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs melphalan and prednisolone. OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days 1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm. Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter. Patients are followed until death. PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 660 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
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma based on at least two of the following: Paraprotein in serum and/or urine Greater than 10% plasma cells in bone marrow Lytic bone lesions Measurable serum and/or urine paraprotein Progression from first or second stable plateau phase No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells) No primary refractory disease or second or later relapse PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 3.4 mg/dL Cardiovascular: No clinically significant cardiac insufficiency No uncontrolled hypertension Other: No uncontrolled diabetes mellitus No recent history of peptic ulceration HIV-1 and HIV-2 negative Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic peripheral blood stem cell or bone marrow transplantation No planned future autologous transplantation unless sufficient stored stem cells available Prior interferon allowed if administered as maintenance of stable plateau phase No concurrent epoetin alfa Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy for pain or to treat localized tumors allowed Surgery: Not specified Other: No prior participation in any clinical trial with an unlicensed product
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