Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma.
- Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen.
- Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation.
- Determine the time to response in patients treated with this regimen.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.
NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.
Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Newly diagnosed Salmon-Durie stage II or III multiple myeloma
- Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks
- Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
- No evidence of cord compression requiring concurrent steroids
PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- No known HIV positivity
- No peripheral neuropathy ≥ grade 2
- No hypersensitivity to bortezomib, boron, or mannitol
PRIOR CONCURRENT THERAPY:
- No prior bortezomib
- More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
- No steroids within 14 days prior to study entry
No concurrent corticosteroids except for the treatment of a nonmalignant condition
- May not exceed the equivalent dose of prednisone 10 mg/day
- No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
- No other concurrent investigational agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Bortezomib and Thalidomide
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Response to Treatment
Periodo de tiempo: 1-6 months
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Clinical evaluations of disease response were determined with each cycle.
Bone marrow biopsies were done at baseline and at study termination.
Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours.
Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.
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1-6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)
Periodo de tiempo: 1-6 months
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Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).
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1-6 months
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Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation
Periodo de tiempo: 1-6 months
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1-6 months
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The Time to Response
Periodo de tiempo: 1-6 months
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1-6 months
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Quality of Life
Periodo de tiempo: 0-6 months
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0-6 months
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Ivan Borrello, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Efectos fisiológicos de las drogas
- Agentes antiinfecciosos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Agentes antibacterianos
- Agentes leprostáticos
- Talidomida
- Bortezomib
Otros números de identificación del estudio
- J0456 CDR0000450772
- P30CA006973 (Subvención/contrato del NIH de EE. UU.)
- JHOC-J0456
- JHOC-04063003
- MILLENNIUM-JHOC-J0456
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