- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00558896
CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis.
- To assess the toxicity of CC-4047 plus dexamethasone in this patient population.
- To assess in an expansion cohort the response rate with an increase in CC-4047 dose among patients who fail to respond adequately to the initial starting dose following the first 2 courses of treatment.
- To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with lenalidomide resistant or refractory multiple myeloma.
- To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with previously treated light chain amyloidosis.
- To assess the response rate and duration of remission with low- and high-dose CC-4047 plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple myeloma.
- To assess the response rate and duration of remission with high-dose CC-4047 plus dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3 treatment regimens.
OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma [closed to accrual as of 8/5/2008] vs lenalidomide resistant/refractory myeloma [closed to accrual as of 4/2/2009] vs previously treated light chain amyloidosis vs lenalidomide and bortezomib resistant/refractory myeloma {low-dose/day}[closed to accrual as of 11/20/09] vs lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs relapsed/refractory myeloma {high-dose/day}).
Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks and then at 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic in Arizona
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic in Florida
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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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:
- Symptomatic multiple myeloma
Previously treated disease meeting one of the following criteria:
- Have light-chain amyloidosis that has been treated with at least one prior regimen
Symptomatic (relapsed or refractory) multiple myeloma
- Patients must have received 1-3 treatment regimens
- Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen
Measurable disease, as defined by 1 of the following:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio
- Measurable soft tissue plasmacytoma, not previously irradiated
- More than 30% plasma cells in bone marrow
- At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index
- No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)
- No smoldering myeloma (not applicable for patients with amyloid)
PATIENT CHARACTERISTICS:
- ECOG performance status 0, 1, or 2
- ANC ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Creatinine ≤ 2.5 mg/dL
Not pregnant or nursing
- Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug
- Negative pregnancy test
Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug
- The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap)
- Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
- Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug
- Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug
- No uncontrolled infection
- No other active malignancy
No New York Heart Association class III or IV cardiac disease (all patients)
- Serum troponin T > 0.10 ng/mL (amyloid patients only)
- No known positivity for HIV or active hepatitis infection
- No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated
- No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study
- No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash
- No peripheral neuropathy > grade 2
PRIOR CONCURRENT THERAPY:
- All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration
- No radiotherapy ≤ 14 days prior to study registration
- No other concurrent anti-myeloma therapy
- No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture
- Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease
- Willing and able to take aspirin or alternate prophylactic anticoagulation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Relapsed Myeloma (<4 Prior Regimens)
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
Experimental: Lenalidomide Refractory Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
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Experimental: Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
Experimental: Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
Experimental: Relapsed Myeloma (< 4 Prior Regimens)
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
Experimental: Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
Experimental: Relapsed Amyloidosis
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle |
40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)
Periodo de tiempo: Duration of study (up to 3 years)
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Response that was confirmed on 2 consecutive evaluations
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Duration of study (up to 3 years)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression Free Survival (PFS)
Periodo de tiempo: Duration of study (up to 5 years)
|
PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method. Progression was defined as any one or more of the following:
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Duration of study (up to 5 years)
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Duration of Response
Periodo de tiempo: Duration of study (up to 5 years)
|
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.
Kaplan Meier method was used to compute this outcome.
|
Duration of study (up to 5 years)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Martha Q. Lacy, MD, Mayo Clinic
Publicaciones y enlaces útiles
Publicaciones Generales
- Dispenzieri A, Buadi F, Laumann K, LaPlant B, Hayman SR, Kumar SK, Dingli D, Zeldenrust SR, Mikhael JR, Hall R, Rajkumar SV, Reeder C, Fonseca R, Bergsagel PL, Stewart AK, Roy V, Witzig TE, Lust JA, Russell SJ, Gertz MA, Lacy MQ. Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. Blood. 2012 Jun 7;119(23):5397-404. doi: 10.1182/blood-2012-02-413161. Epub 2012 Apr 4.
- Lacy MQ, Allred JB, Gertz MA, Hayman SR, Short KD, Buadi F, Dispenzieri A, Kumar S, Greipp PR, Lust JA, Russell SJ, Dingli D, Zeldenrust S, Fonseca R, Bergsagel PL, Roy V, Stewart AK, Laumann K, Mandrekar SJ, Reeder C, Rajkumar SV, Mikhael JR. Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease. Blood. 2011 Sep 15;118(11):2970-5. doi: 10.1182/blood-2011-04-348896. Epub 2011 Jun 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 metabólicas
- 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
- Deficiencias de proteostasis
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Amilosis
- Plasmacitoma
- Efectos fisiológicos de las drogas
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Factores inmunológicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Dexametasona
- Pomalidomida
Otros números de identificación del estudio
- CDR0000574742
- P30CA015083 (Subvención/contrato del NIH de EE. UU.)
- 07-003064 (Otro identificador: Mayo Clinic IRB)
- NCI-2009-01283 (Identificador de registro: NCI-CTRP)
- MC0789 (Otro identificador: Mayo Clinic Cancer Center)
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