- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02092922
A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.
Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Dresden, Alemania
- TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I
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Hamburg, Alemania
- Asklepios Kliniken Hamburg GmbH
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Heidelberg, Alemania
- University Hospital Heidelberg
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Leipzig, Alemania
- University Hospital Leipzig
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Tubingen, Alemania
- University of Tubingen
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Wurzburg, Alemania
- Julius Maximilians Universitat Wurzburg
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Bruxelles, Bélgica
- Institut Jules Bordet
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Leuven, Bélgica
- Universitaire Ziekenhuizen Leuven
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Alberta
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Calgary, Alberta, Canadá
- Tom Baker Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá
- QEII Health Sciences Center
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Quebec
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Montreal, Quebec, Canadá
- Jewish General Hospital
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Badalona, España
- Hospital Germans Trias i Pujol
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Barcelona, España
- Hospital Clínic de Barcelona
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Valencia, España
- Hospital Clínico Universitario de Valencia
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Valencia, España
- Hospital Universitario La Fe
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Zaragoza, España
- Hospital Quiron de Zaragoza
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Alabama
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Birmingham, Alabama, Estados Unidos, 35249
- UAB Comprehensive Cancer Center
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope
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San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado
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Denver, Colorado, Estados Unidos, 80218
- Colorado Blood Cancer Institute
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University, Winship Cancer Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Cancer Center and Medical Pavilion
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Norton Cancer Institute
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
- Center for Cancer and Blood Disorders
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63130
- Washington University in St. Louis
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68506
- Nebraska Hematology Oncology, P.C.
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
- Comprehensive Cancer Centers of Nevada
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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New York, New York, Estados Unidos, 10065
- NY Presbyterian - Weill Cornell Medical Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute
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Durham, North Carolina, Estados Unidos, 27710
- Duke Cancer Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Washington
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Spokane Valley, Washington, Estados Unidos, 99216
- Cancer Care Northwest
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Bierre-Benite Cedex, Francia
- Centre Hospitalier Lyon-Sud
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Lille Cedex, Francia
- Hôpital Claude Huriez
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Marseille Cedex 9, Francia
- Institut Paoli Calmettes
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Nantes Cedex, Francia
- Chu Hotel Dieu
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Nimes Cedex 9, Francia
- G.H.U Caremeau
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Toulouse, Francia
- Institut Universitaire de Cancer
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Tours Cedex, Francia
- CHU tours-Hopital Bretonneau
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Vandoeuvre les Nancy, Francia
- CHU de Nancy - Hopital de Brabois
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Athens, Grecia
- General Hospital of Athens "Evangelismos"
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Athens, Grecia
- University of Athens School of Medicine
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London, Reino Unido
- Kings College Hospital NHS Foundation Trust
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London, Reino Unido
- Barts Health NHS Trust
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Southhampton, Reino Unido
- Southhampton General Hospital
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Surrey, Reino Unido
- The Royal Marsden NHS Foundation Trust
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Wolverhampton, Reino Unido
- New Cross Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
Patients with confirmed multiple myeloma whose treatment history must include all of the following:
- Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
- Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
- Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.
Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:
- A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug.
- Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
- Additional criteria exist.
Key Exclusion Criteria:
- Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study drug. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
- Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
- Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure [New York Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
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: Filanesib
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estándar de cuidado
multiple dose, single schedule
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
Periodo de tiempo: up to 2 years
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up to 2 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
Periodo de tiempo: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of the study drug in terms of duration of response.
Periodo de tiempo: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of the study drug in terms of progression-free survival.
Periodo de tiempo: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of study drug in terms of overall survival.
Periodo de tiempo: up to 2 years
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up to 2 years
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In all patients, assess the safety of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Periodo de tiempo: up to 2 years
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up to 2 years
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In a subset of all patients, characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentration-time profiles.
Periodo de tiempo: 6 months
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6 months
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In a subset of all patients, assess the correlation between study drug exposure and changes in corrected QT interval (QTc) in terms of changes in QTc versus time-matched study drug plasma concentrations.
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
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
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
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Factores inmunológicos
- Agentes antimitóticos
- Moduladores de mitosis
- Adyuvantes, Inmunológicos
- Lenograstim
- Filanesib
Otros números de identificación del estudio
- ARRAY-520-215
- 2014-001051-23 (Número EudraCT)
- C4371002 (Otro identificador: Pfizer)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .
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