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    Summary
    EudraCT Number:2009-017930-35
    Sponsor's Protocol Code Number:AB06002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-017930-35
    A.3Full title of the trial
    Estudio de fase 3, prospectivo, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de 2 grupos paralelos, para comparar la eficacia y la seguridad de masitinib 6 mg/kg/día en combinación con bortezomib y dexametasona, con placebo en combinación con bortezomib y dexametasona en el tratamiento de pacientes con mieloma múltiple recidivante que han recibido una terapia previa
    A.4.1Sponsor's protocol code numberAB06002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAB Science
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/286
    D.3 Description of the IMP
    D.3.1Product namemasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/286
    D.3 Description of the IMP
    D.3.1Product namemasitinib mesylate
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pacientes con mieloma múltiple recidivante que han recibido una terapia previa
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo principal
    Supervivencia libre de progresión (SLP) de acuerdo con Internacional Myeloma Working Group criteria 2009 (IMWG / criterios Bladé revisados). (Análisis a llevar a cabo después de un mínimo de 201 casos).
    E.2.2Secondary objectives of the trial
    Objetivos secundarios
    Progresión de enfermedad:
    - Tiempo hasta la progresión (TTP) de acuerdo con Internacional Myeloma Working Group criteria 2009 (IMWG / criterios Bladé revisados)
    - Tiempo hasta el siguiente tratamiento (TTNT)
    Supervivencia:
    - Supervivencia global (SG)
    Respuesta:
    Mejor tasa de respuesta durante el estudio, de acuerdo con Internacional Myeloma Working Group criteria 2009 (IMWG / criterios Bladé revisados)
    Evaluación de la calidad de vida:
    - Calidad de vida de acuerdo con el cuestionario QLQ-C30 EORTC en las semanas 12, 24, 36, 48, 64 y 72
    - Estado funcional ECOG en las semanas 12, 24, 36, 48, 64 y 72
    - Escala de valoración verbal (VRS) del dolor óseo en las semanas 12, 24, 36, 48, 64 y 72
    - Consumo de analgésicos (no opiáceos) en las semanas 12, 24, 36, 48, 64 y 72
    - Consumo de opiáceos en las semanas 12, 24, 36, 48, 64 y 72

    Evaluaciones de seguridad:
    - Perfil de seguridad según la clasificación CTC del NCI v 4.02
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión
    1. Paciente con mieloma múltiple confirmado que requiere terapia sistémica. Deben cumplirse estos 3 criterios:
    Células plasmáticas clonales en médula ósea mayor o igual a 10%
    Presencia de proteína monoclonal sérica y/o urinaria
    Pruebas de daño orgánico terminal que puede ser atribuido a un trastorno proliferativo subyacente de las células plasmáticas, concretamente:
    - Hipercalcemia: calcio sérico mayor o igual a 11,5 mg/100 ml o
    - Insuficiencia renal: creatinina sérica > 173 µmol/l
    - Anemia: normocrónica, normocítica con un valor de hemoglobina > 2 g/100 ml por debajo del límite inferior de la normalidad o un valor de hemoglobina < 10 g/100 ml
    - Lesiones óseas: lesiones líticas, osteopenia severa o fracturas patológicas
    2. Paciente con mieloma múltiple recidivante de acuerdo con los criterios internacionales de respuesta uniforme para el mieloma múltiple (IMWG 2009 / criterios Bladé revisados) a una línea de tratamiento previa. Los pacientes tratados previamente con bortezomib por mieloma múltiple podrán ser incluidos si, y sólo si:
    - han mostrado una respuesta mínima, parcial o completa a este tratamiento
    - no han sido refractarios a este tratamiento (se considerará paciente refractario a bortezomib a cualquier paciente que no haya mostrado respuesta alguna a un tratamiento previo con bortezomib o cuya enfermedad haya progresado durante o en un plazo de 60 días desde el inicio del tratamiento con bortezomib)
    3. Paciente candidato a recibir la terapia estándar (bortezomib y dexametasona)
    4. Paciente con enfermedad progresiva cuantificable definida al menos por una de las dos determinaciones siguientes:
    - Proteína M sérica mayor o igual a 1 g/dl
    - Proteína M en orina mayor o igual a 200 mg/24 h
    5. Paciente con ECOG menor o igual a 2
    6. Paciente con función orgánica adecuada
    - Recuento absoluto de neutrófilos (RAN) mayor o igual a 1,5 giga/l
    - Plaquetas (PTL) mayor o igual a 75 x 109/l
    - AST / ALT < 2,5 LSN
    - Aclaramiento de creatinina > 30 ml/min
    - Bilirrubina < 1,5 LSN
    - Albúmina > 1 x LIN
    - Urea < 2 x LSN
    - Albuminuria < 300 mg/día
    7. Paciente con una esperanza de vida > 6 meses
    8. Hombre o mujer no embarazada ni en periodo de lactancia, edad > 18 años, peso > 40 Kg y BMI > 18 kg/m2
    9. Los hombres y las mujeres con capacidad de procrear (que entran en el estudio tras un periodo menstrual y que presentan una prueba de embarazo negativa) deberán aceptar el uso de dos métodos (uno para el paciente y otro para su pareja) anticonceptivos médicos aceptables durante el estudio y durante los 3 meses siguientes a la última dosis de tratamiento.
    10. Paciente capaz y con buena disposición de cumplir con los procedimientos del estudio según el protocolo
    11. Paciente capaz de comprender, firmar y fechar el documento de consentimiento informado por escrito en la visita de selección, antes de ningún procedimiento específico del protocolo
    E.4Principal exclusion criteria
    Criterios de exclusión
    1. Pacientes con neuropatía periférica Grado > 2
    2. Paciente con hipersensibilidad al bortezomib, el boro o la dexametasona
    3. Paciente cuya enfermedad progresó durante o en un plazo de 60 días desde el inicio del tratamiento con bortezomib o desde cualquier otra terapia para el mieloma múltiple
    4. Paciente que recibió bortezomib en los 6 meses previos a la aleatorización en este estudio
    5. Interrupción de bortezomib en el pasado debida a un acontecimiento adverso asociado de grado 3 o superior
    6. Paciente con contraindicación de altas dosis de esteroides (incluyendo infección activa continuada, uso de vacunas vivas, virasis tales como hepatitis, herpes, varicela, herpes zoster)
    7. Paciente con enfermedad pulmonar infiltrativa difusa aguda y enfermedad pericárdica
    8. Paciente tratado de un cáncer distinto al mieloma múltiple en un plazo de cinco años antes del reclutamiento, a excepción del carcinoma de células basales y el cáncer cervical in situ
    9. Paciente con metástasis en sistema nervioso central (SNC) o con historia de metástasis en SNC
    10. Paciente con una de las siguientes afecciones cardiacas:
    Paciente con antecedentes cardíacos recientes (en los últimos 6 meses) de:
    - Síndrome coronario agudo
    - Insuficiencia cardíaca aguda (clase III o IV de la clasificación HYHA)
    - Arritmia ventricular significativa (taquicardia ventricular persistente, fibrilación ventricular, reanimación por muerte súbita)
    Paciente con insuficiencia cardíaca de clase III o IV de la clasificación HYHA.
    Paciente con trastornos de conducción graves que no se previenen mediante electroestimulación cardíaca permanente (bloqueo auriculoventricular de grados 2 y 3, bloqueo sinoauricular).
    Síncope de etiología desconocida en los últimos 3 meses.
    Hipertensión grave no controlada, según el criterio del investigador, o hipertensión sintomática.
    11. Pacientes con historia de pobre cumplimiento o historia de abuso de alcohol o drogas, o consumo excesivo de bebidas alcohólicas que pueda interferir con la capacidad para cumplir con el protocolo del estudio, o enfermedad psiquiátrica presente o pasada que pueda interferir con la capacidad para cumplir con el protocolo del estudio o para otorgar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Variable primaria
    Supervivencia libre de progresión (SLP) de acuerdo con los criterios del Grupo de Trabajo Internacional para el Mieloma 2009 (IMWG / criterios Bladé revisados) definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de una progresión documentada o de la muerte durante el estudio. La progresión de acuerdo con los criterios IMWG 2009 (criterios revisados de Bladé) se definen en la

    Tabla 1 1.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No aplica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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