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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41008   clinical trials with a EudraCT protocol, of which   6704   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-000293-62
    Sponsor's Protocol Code Number:GEM11-BENVELPRES
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-11-03
    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 number2011-000293-62
    A.3Full title of the trial
    Phase II, Open, National, Multicenter Study of Bendamustine, Bortezomib (Velcade) and prednisone (BVP) in patients with newly diagnosed multiple myeloma (BenVelPres)
    Estudio de Fase II Abierto, Nacional, Multicéntrico de Bendamustina, Bortezomib (Velcade) y Prednisona (BVP) en Pacientes con Mieloma Múltiple de Nuevo Diagnóstico (BenVelPres)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, Open, National, Multicenter Study of Bendamustine, Bortezomib (Velcade) and prednisone (BVP) in patients with newly diagnosed multiple myeloma (BenVelPres)
    Estudio de Fase II Abierto, Nacional, Multicéntrico de Bendamustina, Bortezomib (Velcade) y Prednisona (BVP) en Pacientes con Mieloma Múltiple de Nuevo Diagnóstico (BenVelPres)
    A.4.1Sponsor's protocol code numberGEM11-BENVELPRES
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación PETHEMA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundación PETHEMA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support, S.L.
    B.5.2Functional name of contact pointBegoña García
    B.5.3 Address:
    B.5.3.1Street AddressCalle Arturo Soria, 336
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491125 05 50
    B.5.5Fax number+3491125 05 51
    B.5.6E-mailbegona.garcia@tfscro.com
    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 Yes
    D.2.1.1.1Trade name VELCADE 3,5 mg, polvo para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVelcade
    D.3.2Product code Velcade
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    Intravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.3Other descriptive nameBORTEZOMIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m3 milligram(s)/cubic meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.1.1.1Trade name LEVACT 2,5 mg/ml polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLEVACT
    D.3.2Product code LEVACT
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENDAMUSTINA HIDROCLORURO
    D.3.9.1CAS number 16506-27-7
    D.3.9.3Other descriptive nameBENDAMUSTINA HIDROCLORURO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePREDNISONA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNPREDNISONA
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MULTIPLE MYELOMA
    MIELOMA MÚLTIPLE
    E.1.1.1Medical condition in easily understood language
    MULTIPLE MYELOMA
    MIELOMA MÚLTIPLE
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Analizar la eficacia (en términos de tasa de respuesta y tasa de remisión completa) de BVP.
    E.2.2Secondary objectives of the trial
    -Determinar la seguridad y tolerancia de BVP, valorados por la incidencia de toxicidades clínicas y de laboratorio.
    -Comparar los resultados de BVP con nuestros propios resultados con VMP obtenidos en el ensayo GEM10MAS65, en términos de eficacia y toxicidad.
    Evaluar los datos de supervivencia, ej. Tiempo hasta la progresión, supervivencia libre de progresión y supervivencia global.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Paciente capaz, en opinión del médico, de cumplir con el horario de visitas y otros requerimientos del protocolo
    Paciente de nuevo diagnóstico, con mieloma múltiple sintomático basado en los criterios estándar y que no ha recibido ningún tratamiento previo de quimioterapia para el MM.
    Paciente con mieloma múltiple de nuevo diagnóstico, secretor, u oligosecretor o no secretor si tiene plasmocitomas de tejido blando.
    Los pacientes con MM oligosecretor o no secretor sin plasmocitomas en tejido blando serán excluidos para mantener un grupo de pacientes con características similares a la del estudio previo con el que queremos comparar los resultados.
    Paciente con enfermedad medible, definida por los siguientes criterios:
    Para el MM secretor, la enfermedad medible se define como cualquier valor cuantificable de proteína monoclonal en suero ( 1g/dl) y , cuando sea aplicable, una excreción de cadena ligera en orina 200 mg/24 horas.
    Para Mieloma Múltiple oligosecretor o no secretor, la enfermedad medible se define por la presencia de plasmocitomas de tejido blando (no óseo) determinados mediante examen clínico o métodos radiográficos (ej. MRI, CT-Scan).
    Estado funcional ECOG 2 (Anexo 4)
    Expectativa de vida >3 meses.
    El paciente presenta los siguientes valores de laboratorio dentro de los 28 días anteriores a la visita basal (Día 1 del ciclo 1, antes de que se administre el fármaco de estudio):
    Recuento de plaquetas 100 x109/l, hemoglobina 8.0g/dl y recuento absoluto de neutrófilos (RAN) 1.5 x 109/l; se permiten recuentos menores si son claramente debidos a una infiltración de la médula ósea por el MM.
    Calcio sérico corregido < 14mg/dl.
    Aspartato transaminasa (AST) 2.5 x el límite superior de normalidad (LSN).
    Alanina transaminasa (ALT) 2.5 x LSN.
    Bilirrubina total dentro de los límites de normalidad.
    Creatinina sérica < 2 mg/dl
    Los pacientes en edad fértil deben usar anticonceptivos efectivos durante la duración del estudio y hasta 6 meses tras la finalización del tratamiento.
    E.4Principal exclusion criteria
    Paciente que haya recibido previamente tratamiento para el Mieloma Múltiple, con la excepción de pulsos de esteroides por alguna urgencia que lo requiera previo a iniciar el tratamiento de inducción, la administración de bisfosfonatos o la administración de radioterapia, bien antiálgica o debido a la presencia de plasmocitomas, que la requieran por alguna urgencia.
    Paciente con enfermedad no medible.
    Paciente que tengan una neuropatía periférica grado 2 (criterios CTC v 4.0) dentro de los 14 días previos a su inclusión.
    Paciente con hipersensibilidad conocida al bortezomib, ácido bórico, bendamustina o manitol.
    Paciente que sea conocido portador del virus de la inmunodeficiencia humana (VIH), antígeno de superficie del virus de la hepatitis B o infección activa por el virus de la hepatitis C.
    Paciente que haya tenido un infarto de miocardio en los 6 meses previos a la inclusión en el ensayo clínico o posea una clase funcional III o IV de acuerdo con New York Heart Association (NYHA), insuficiencia cardiaca, angina no controlada, arritmias ventriculares no controladas o isquemia aguda detectada electrocardiográficamente o trastornos del sistema de conducción.
    Paciente que haya recibido cualquier agente en investigación en los 30 días previos a su inclusión o que esté actualmente en otro ensayo clínico o recibiendo cualquier agente en investigación.

    Paciente sometido a una cirugía mayor < 30 días antes de su inclusión en el estudio
    Paciente con enfermedad pulmonar infiltrativa difusa aguda y/o enfermedad pericárdica.
    Historia previa de otras enfermedades malignas diferentes al mieloma (excepto para carcinoma basal o escamoso de la piel, o carcinoma in situ de cérvix o mama) a menos que el paciente se encuentre libre de enfermedad más allá de 5 años.
    Hipertensión arterial o diabetes mellitus mal controladas o cualquier otra enfermedad orgánica grave que suponga un riesgo excesivo para el paciente
    Cualquier alteración psiquiátrica que interfiera con la comprensión del consentimiento informado o impida el normal cumplimiento al que obliga la participación en este ensayo.
    Pacientes que tengan antecedentes psiquiatricos mayores.
    E.5 End points
    E.5.1Primary end point(s)
    -Analizar la eficacia (en términos de tasa de respuesta y tasa de remisión completa) de BVP
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    -Determinar la seguridad y tolerancia de BVP, valorados por la incidencia de toxicidades clínicas y de laboratorio.
    -Comparar los resultados de BVP con nuestros propios resultados con VMP obtenidos en el ensayo GEM10MAS65, en términos de eficacia y toxicidad.
    -Evaluar los datos de supervivencia, ej. Tiempo hasta la progresión, supervivencia libre de progresión y supervivencia global.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    Can be terminated prematurely if there is reasonable cause enough. The circumstances justifying the suspension of the study include, but are not limited to: Determination of unforeseen risks, substantial or unacceptable for Failure to enroll patients to an acceptable number of patients Insufficient compliance with the requirements of the protocol Plans modification, suspension or discontinuance development of drug study
    Puede ser interrumpido prematuramente si existe una causa razonable suficiente. Las circunstancias que justifican la suspensión del estudio incluyen, pero no se limitan a: Determinación de riesgos imprevistos, considerables o inaceptables para los pacientes Imposibilidad de inscribir a un número aceptable de pacientes Insuficiente cumplimiento de los requisitos del protocolo Planes de modificación, suspensión o discontinuidad del desarrollo del fármaco del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    There are not plans for treatment or care after the subject has ended the participation in the trial
    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 Decision2011-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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