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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2005-000186-19
    Sponsor's Protocol Code Number:VELCADEXA
    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:2006-05-16
    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 number2005-000186-19
    A.3Full title of the trial
    Estudio nacional, multicéntrico, abierto, de tratamiento de inducción con VELCADE y Dexametasona (VELCADEXA) en régimen alternante, previo a trasplante en pacientes menores de 65 años con mieloma múltiple no tratados previamente
    A.4.1Sponsor's protocol code numberVELCADEXA
    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 SponsorFUNDACION 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 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 Information not present in EudraCT
    D.2.1.1.1Trade name VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    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.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBORTEZOMIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square 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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeagente antineoplásico
    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 Information not present in EudraCT
    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 nameDEXAMETASONA
    D.3.4Pharmaceutical form Capsule*
    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 INNdexametasona
    D.3.9.1CAS number 50-02-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typecorticoesteroide para uso sistémico
    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
    Pacientes de edades comprendidas entre 18 y 65 años, con diagnóstico de mieloma múltiple, con enfermedad sintomática y que no han recibido quimioterapia con anterioridad para el mieloma múltiple.
    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
    Estudiar la eficacia en términos de tasa de respuesta a la pauta alternante Bortezomib/Dexametasona
    E.2.2Secondary objectives of the trial
    1- Estudiar la rapidez y grado de respuesta (variación en la cuantía del componente M en suero y orina) tras cada tratamiento con bortezomib y dexametasona.
    2- Compara la eficacia de la pauta Bortezomib/Dexametasona con la combinación actual alternante VBMCP/VBAD de terapia de inducción previa a la terapia de intensificación con trasplante autólogo. Con este fin se compararán los resultados obtenidos con Bortezomib/Dexametasona con los alcanzados en los últimos 100 pacientes tratados con el régimen VBMCP/VBAD en las mismas instituciones participantes.
    3- Evaluar la calidad de la recolección de células madre tras Bortezomib/Dexametasona en comparación con la obtenida con nuestro actual régimen VBMCP/VBAD
    4- Comparar la tasa de RC tras HDT/SCT en pacientes tratados con inducción mediante Bortezomib/ Dexametasona frente a la tasa de RC en pacientes tratados con inducción mediante el régimen VBMCP/VBAD
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1- El paciente se encuentra, en opinión del investigador, dispuesto y capacitado para cumplir con los requisitos del protocolo
    2- El paciente ha otorgado voluntariamente su consentimiento informado por escrito antes de la realización de cualquiera de los procedimientos relacionados con el estudio, que no forman parte de la atención médica normal, entendiendo que dicho consentimiento puede ser retirado por parte del paciente en cualquier momento sin que ello suponga un perjuicio en su atención médica futura
    3- Edad mayor de 18 años y menor de 65
    4- Se trata de un paciente con diagnostico reciente de mieloma múltiple sintomático, según los criterios estandar y que no ha recibido ningún tratamiento anterior con quimioterapia para el mieloma múltiple.
    5- El paciente presenta una enfermedad medible, definida como sigue:
    . Para el mieloma múltiple secretor, la enfermedad medible se define como cualquier valor de proteina monoclonal cuantificable en suero y, si procede, excreción de cadena ligera en orina mayuor o igual a 200 mg/24h
    . Para el mieloma múltiple oligosecretor o no secretor, la enfermedad medible se define por la presencia de plasmocitomas de tejido blando (no óseo), determinados en el examen clínico o radiológico pertinente (p.e. MRI, CT-Scan). En pacientes con mieloma múltiple oligosecretor, las mediciones de proteína M en suero y/o en orina son muy bajas y de dificil seguimiento para la evaluación de la respuesta. En los pacientes con mieloma múltiple no secretor, no se detecta proteína M en suero o en orina mediante inmunofijación.
    6- El paciente posee un estado funcional de ECOG menor o igual a 2
    7- El paciente posee una esperanza de vida superior a 3 meses
    8- El paciente presenta los isguientes valores de laboratorio en los 14 días anteriores a la visita inicial (dia 1 del ciclo 1, antes de la administración del fármaco de estudio):
    . Recuento plaquetario mayor o igual a 50000/mm3
    . Hemoglobina mayor o igual a 8 g/dl
    . Recuento absoluto de neutrófilos (ANC) mayor o igual a 1000/mm3
    . Calcio en suero corregido menor o igual a 14 mg/dl
    . AST inferior o igual a 2.5 x el límite superior normal
    . ALT inferior o igual a 2.5 x el límite superior normal
    . Bilirrubina total inferior o igual a 1.5 x el límite superior normal
    . Valor de creatinina sérica menor o igual a 2 mg/dl
    E.4Principal exclusion criteria
    1- Paciente que anteriormente ha recibido tratamiento con VELCADE
    2- Paciente que anteriormente ha recibido tratamiento para el mieloma múltiple
    3- Paciente sometido a cirugía mayor en las 4 semanas anteriores al reclutamiento
    4- Paciente con reduento plaquetario menor de 50000/mm3 en los 14 dias anteriores al reclutamiento
    5- Paciente con recuento absoluto de neutrofilos menor de 1000/mm3 en los 14 dias anteriores al reclutamiento
    6- Paciente con neuropatía periférica mayor o igual a grado 2 en los 14 dias anteriores al reclutamiento
    7- Paciente con hipersensibilidad frente al Bortezomib, ácido bórico o manitol
    8- Paciente que ha recibido otros fármacos en investigación en los 14 dias anteriores al reclutamiento
    9- Paciente con seropositividad conocida frente al virus de la inmunodeficiencia humana (VIH), al antígeno de superficie de la hepatitis B o con infección de hepatitis C activa.
    10- Paciente que ha sufrido un infarto de miocqardio en los 6 meses anteriores al reclutamiento o que presenta una insuficiencia cardiaca de cualquier clase (I,II,III ó IV según la AQsociación de Cardiología de New York -NYHA-), angina inestable, isquemia aguda, anomalías del sistema de conducción activas o cualquier otra condición o dolencia cariológica que, a juicio del especialista, suponga un factor de riesgo para desarrollar insuficiencia cardiaca, digno a tener en cuenta.
    11- Paciente que participa en otro estudio de investigación clínica y/o está siendo tratado con un producto en investigación por cualquier motivo.
    12- Embarazo, lactancia o mujeres potencialmente fértiles que no utilizan ni utilizarán durante el estudio un método anticonceptivo efectivo aprobado médicamente
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta (RC,RP,RM) a Velcadexa
    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 Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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.8.5The 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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2005-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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