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    The EU Clinical Trials Register currently displays   38892   clinical trials with a EudraCT protocol, of which   6392   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-006868-11
    Sponsor's Protocol Code Number:RV-MM-AMWG-407
    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:2008-11-25
    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 number2008-006868-11
    A.3Full title of the trial
    Estudio Fase II de Combinación de Lenalidomida/Ciclofosfamida a dosis metronómicas/Prednisona para el tratamiento de pacientes mayores de 75 años con mieloma múltiple de nuevo diagnóstico
    A.4.1Sponsor's protocol code numberRV-MM-AMWG-407
    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 SponsorAsociación Andaluza de Hematología
    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 Yes
    D.2.1.1.1Trade name Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/177
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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
    Evaluar la tasa de respuesta en base al criterio del International Myeloma Working Group de las siguientes respuestas (sCR, CR, VGPR, PR) al finalizar cada ciclo en los 3 primeros ciclos y cada tres meses tras el tercer ciclo.
    E.2.2Secondary objectives of the trial
    Tiempo Hasta Progresión, Supervivencia Global, Supervivencia Libre de Progresión, Mortalidad Temprana
    Tolerabilidad del esquema de tratamiento
    Toxicidad del esquema de tratamiento
    Respuesta Eritroide (Respuesta Mayor, Respuesta Menor)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Paciente mayor de 75 años.
    2. Pacientes con Mieloma Múltiple sintomático diagnosticado de novo. Serán considerados aquellos pacientes que presenten uno o más de los siguientes datos clínicos o analíticos atribuibles al mieloma: dolores óseos, síndrome anémico, infecciones bacterianas de repetición, diátesis hemorrágica, disminución del peso corporal superior al 10% en los últimos 6 meses, síndrome de hiperviscosidad, hipercalcemia, plasmocitomas extramedulares o una cifra de creatinina sérica superior a 2 mg/dL.
    3. El paciente debe entender el consentimiento informado escrito y firmarlo por propia voluntad.
    4. El paciente debe ser capaz de cumplir con las todas visitas programadas y otros requisitos.
    5. El paciente varón incluido en el ensayo debe comprometerse a usar siempre preservativo de látex durante cualquier contacto sexual con mujeres en edad fértil, incluso si ha sido sometido a una vasectomía realizada con éxito.
    NOTA: Se desconoce si lenalidomida está presente en el semen de pacientes que reciben el medicamento. Por lo tanto, los hombres en tratamiento con REVLIMID® (lenalidomida) deben usar siempre preservativos de látex durante cualquier contacto sexual con mujeres en edad fértil, incluso si han sido sometidos a una vasectomía realizada con éxito.
    Si el paciente mantiene relaciones sexuales con una mujer sin usar un preservativo de látex o si cree por alguna razón que ésta puede estar embarazada debe comunicárselo inmediatamente a su médico.
    6. los pacientes deben comprometerse a no donar esperma mientras se encuentren en tratamiento con Lenalidomida.
    NOTA: No está permitido la inclusión del mismo paciente más de una vez
    E.4Principal exclusion criteria
    1. Cualquier Enfermedad concomitante, desorden psiquiátrico o razón psico-social que pueda presuponer incumplimiento de protocolo.
    2. PS > 3 según la escala del ECOG (Apéndice II).
    3. Cualquiera de las siguientes anomalías de laboratorio:
    - Recuento Absoluto de Neutrófilos (ANC) < 1.000 células/ mm3 (1.0 x 109/L) (no atribuible a infiltración del mieloma)
    - Recuento de plaquetas sin transfusión < 50.000 células/ mm3 (50 x 109/L) (no atribuible a infiltración del mieloma)
    - SGOT/AST o SGPT/ALT sérica > 3.0 x límite superior de normal (ULN)
    4. Historial previo de afecciones, distintas del mieloma múltiple, a menos que el paciente haya estado libre de la enfermedad durante ≥ 3 años. Las excepciones incluyen lo siguiente:
    - Carcinoma basocelular de la piel
    - Carcinoma escamocelular de la piel
    - Carcinoma in situ de cérvix
    - Carcinoma in situ de mama
    - Hallazgos histológicos incidentales de cáncer de próstata (estadío TNM de T1a o T1b)
    5. Pacientes que son incapaces o no están dispuestos a someterse a una terapia antitrombótica.
    6. Serología positiva conocida para el virus de la inmunodeficiencia humana HIV o hepatitis infecciosa activa, tipo A, B, o C.
    7. Cualquier afección médica grave que haga que el paciente tome un riesgo inaceptable si participa en este estudio.
    8. Pacientes tratados con cualquier fármaco en investigación durante el mes anterior.
    9. Cualquier condición médica severa, anormalidad en las pruebas de laboratorio o cualquier enfermedad psiquiátrica que impidiese la firma del consentimiento escrito.
    E.5 End points
    E.5.1Primary end point(s)
    Respuesta Completa Estricta (stringent Complete Response, sCR)
    Respuesta Completa (Complete Response, CR)
    Respuesta Parcial muy buena (Very Good Partial Response, VGPR)
    Respuesta Parcial (Partial Response, PR)
    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 No
    E.8.1.2Open No
    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) 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 concerned2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2009-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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