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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:2005-001111-21
    Sponsor's Protocol Code Number:GEM05MAS65
    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:2005-10-06
    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 number2005-001111-21
    A.3Full title of the trial
    Estudio Fase III Nacional, Abierto, Multicéntrico, Randomizado, Comparativo de tratamiento de inducción con Melfalán/Prednisona/VelcadeÒ versus Talidomida/Prednisona/VelcadeÒ seguido de tratamiento de mantenimiento con Talidomida/VelcadeÒ versus Prednisona/VelcadeÒ en pacientes con Mieloma Múltiple sintomático de nuevo diagnóstico mayores de 65 años.
    A.4.1Sponsor's protocol code numberGEM05MAS65
    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 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 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 INTERNATIONAL
    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 typeInhibidor del proteasoma
    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.2.1.1.1Trade name THALIDOMIDE PHARMION
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMION LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTHALIDOMIDE PHARMION
    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 INNTALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 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
    Pacientes mayores de 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
    · Objetivo principal: Analizar la eficacia (en términos de tasa de respuesta con especial atención a la tasa de RC y en términos de duración de la respuesta) de los dos esquemas de quimioterapia propuestos como tratamiento de inducción. (en términos de duración de la respuesta) y de los dos esquemas de quimioterapia propuestos como tratamiento de mantenimiento.
    · Evaluar el estado de salud global de los pacientes mediante los resultados notificados por los pacientes (RNP) a través de un cuestionario rellenado por ellos mismos, (QLQ-C30 y QLQ-MY24 de la EORTC). El cuestionario QLQ-MY24 supone un modulo de 24 preguntas añadido al QLQ-C30, específico para pacientes con MM.1
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad y tolerancia de los dos esquemas de tratamiento de inducción y mantenimiento propuestos en pacientes con MM sintomático de nuevo diagnóstico mayores de 65 años, medida en función de la incidencia de toxicidades clínica y de laboratorio.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1·El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
    2·El paciente debe firmar voluntariamente el consentimiento informado antes de la realización de cualquier prueba del ensayo que no forme parte de la atención habitual de los pacientes, con el conocimiento por parte del paciente que puede abandonar el ensayo en el momento que quiera, sin que se vea perjudicado en ningún momento su atención posterior.
    3·Edad > 65 años.
    4·El paciente debe estar diagnosticado de Mieloma Múltiple sintomático según los criterios establecidos28 y no puede haber recibido previamente ningún tratamiento para su enfermedad (ver Anexo 7). Está permitida la administración de pulsos de esteroides por alguna urgencia que lo requiera previo a iniciar el tratamiento de inducción o la administración de bisfofonatos.
    5·El paciente debe tener enfermedad medible, definida como sigue: q Para Mieloma Múltiple secretor, la enfermedad medible es definida por la presencia de componente monoclonal cuantificable en suero o, en orina si la excreción de cadenas ligeras es superior o igual a 200 mg/24 horas.
    6·El paciente debe tener un estado general medido mediante la escala de ECOG £ 2 (ver Anexo 5).
    7·El paciente debe tener una esperanza de vida superior a 3 meses.
    8·El paciente debe tener los siguientes valores de laboratorio previamente al inicio del tratamiento de inducción correspondiente:
    Recuento de plaquetas ≥ 50000/mm3, hemoglobina ≥ 8 g/dl y recuento absoluto de neutrófilos ≥ 1000/mm3. Valores más bajos están permitidos si son debidos a infiltración de la MO.
    Calcio sérico corregido ≤14mg/dl.
    Aspartato transaminasa (AST): ≤ 2.5 x el límite superior de lo normal.
    Alanina transaminasa (ALT): ): ≤ 2.5 x el límite superior de lo normal.
    Bilirrubina total: ≤1.5 x el límite superior de lo normal.
    Creatinina sérica ≤ 2 mg/dl.
    E.4Principal exclusion criteria
    · Pacientes que hayan 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 o la administración de bisfofonatos.
    · Mieloma no-secretor
    · Pacientes que tengan una neuropatía periférica ³ Grado 2 dentro de los 14 días previos a su inclusión.
    · Paciente sometido a cirugía mayor en las 4 semanas anteriores al reclutamiento
    · Pacientes con hipersensibilidad conocida al bortezomib, ácido bórico o manitol.
    · Pacientes que hayan recibido cualquier agente en investigación en los 30 días previos a su inclusión.
    · 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.
    · Pacientes que hayan 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) , fallo cardiaco, angina no controlada, arritmias ventriculares no controladas o isquemia aguda detectada electrocardiográficamente o anormalidades del sistema de conducción.
    · Pacientes que estén actualmente en otro ensayo clínico o recibiendo cualquier agente en investigación.
    E.5 End points
    E.5.1Primary end point(s)
    · Tasa de respuestas (con especial atención a las Remisiones Completas (RC)) en los dos grupos de tratamiento de inducción propuestos para pacientes con MM sintomático de nuevo diagnóstico mayores de 65 años.
    · Duración de la respuesta en cada grupo de tratamiento de mantenimiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 years6
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state260
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 260
    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 Decision2005-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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