Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
10 de febrero de 2014 actualizado por: Genzyme, a Sanofi Company
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Tipo de estudio
Intervencionista
Inscripción (Actual)
302
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Heidelberg, Alemania, 69120
- Universitätsklinikum Heidelberg,
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- City of Hope Samaritan Bone Marrow Transplant Program
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope National Medical Center
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai
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Los Angeles, California, Estados Unidos, 90095
- University of California
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Rocky Mountain Cancer Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University School of Medicine
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- University of Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Indiana
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Beech Grove, Indiana, Estados Unidos, 46107
- Indiana Blood and Marrow Transplantation Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hosptials and Clinics
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Fairview-University Medical Center, University of Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Kansas City Cancer Center
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- The Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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New York, New York, Estados Unidos, 10011
- St. Vincent's Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering
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New York, New York, Estados Unidos, 10032
- New York Hospital
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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Lackland AFB, Texas, Estados Unidos, 78236
- Wilford Hall Medical Center
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San Antonio, Texas, Estados Unidos, 78229
- Texas Transplant Institute
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- Utah Blood and Marrow Transplant Program, University of Utah
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 78 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of multiple myeloma in first or second complete or partial remission
- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) > 2.5*10^9/L
- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
- Platelet (PLT) > 100*10^9/L
- Serum creatinine <=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
Exclusion Criteria):
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: G-CSF más plerixafor
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Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Otros nombres:
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Comparador de placebos: G-CSF más placebo
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Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received placebo, administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Periodo de tiempo: up to Day 6
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Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis.
Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
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up to Day 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Número de participantes con eventos adversos
Periodo de tiempo: hasta el día 38
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Número de participantes con eventos adversos (EA) emergentes del tratamiento.
El período de tiempo para los AA emergentes del tratamiento se define desde el Día 1 (inicio de la movilización de G-CSF) hasta el día antes de comenzar la quimioterapia (aproximadamente 38 días después).
Se informaron EA independientemente de la relación con el tratamiento del estudio.
El investigador calificó cada AA utilizando la Escala de calificación de eventos adversos de la Organización Mundial de la Salud (OMS).
Los EA de grado 3 se consideraron graves y los de grado 4 potencialmente mortales.
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hasta el día 38
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Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Periodo de tiempo: up to Day 8
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Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
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up to Day 8
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Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Periodo de tiempo: up to Day 8
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Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
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up to Day 8
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Median Number of Days to ≥6*10^6 CD34+ Cells/kg
Periodo de tiempo: up to Day 8
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The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
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up to Day 8
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Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Periodo de tiempo: Up to Month 13
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The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
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Up to Month 13
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Median Number of Days to Platelet (PLT) Engraftment
Periodo de tiempo: Up to Month 13
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The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
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Up to Month 13
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Graft Durability at 100 Days Post Transplantation
Periodo de tiempo: approximately Day 138
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The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Day 138
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Graft Durability at 6 Months Post Transplantation
Periodo de tiempo: approximately Month 7
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The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Month 7
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Graft Durability at 12 Months Post Transplantation
Periodo de tiempo: approximately Month 13
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The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Month 13
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2005
Finalización primaria (Actual)
1 de octubre de 2006
Finalización del estudio (Actual)
1 de enero de 2008
Fechas de registro del estudio
Enviado por primera vez
11 de febrero de 2005
Primero enviado que cumplió con los criterios de control de calidad
11 de febrero de 2005
Publicado por primera vez (Estimar)
14 de febrero de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
10 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
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 Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- Factores inmunológicos
- Adyuvantes, Inmunológicos
- Lenograstim
- Plerixafor
Otros números de identificación del estudio
- AMD3100-3102
- 2005-003599-39 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .