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    Summary
    EudraCT Number:2005-001554-24
    Sponsor's Protocol Code Number:Protocolen°04.004.01/IFM200502
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-03-08
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001554-24
    A.3Full title of the trial
    INTERET D’UN TRAITEMENT D’ENTRETIEN PAR REVLIMID APRES AUTOGREFFE DE CELLULES SOUCHES CHEZ LES PATIENTS DE MOINS DE 65 ANS ATTEINTS DE MYELOME
    (Essai de phase III, multicentrique, randomisé, double aveugle, versus placebo)
    A.3.2Name or abbreviated title of the trial where available
    IFM 2005-02
    A.4.1Sponsor's protocol code numberProtocolen°04.004.01/IFM200502
    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 SponsorCHU de TOULOUSE
    B.1.3.4CountryFrance
    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 (LENALIDOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, Royaume-Uni
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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/3/04/192
    D.3 Description of the IMP
    D.3.1Product nameRevlimid Lenalidomide
    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.3.9.3Other descriptive nameLenalidomide or Revlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRevlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeImmunomodulatory agent
    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 REVLIMID (LENALIDOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, Royaume-Uni
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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/3/04/192
    D.3 Description of the IMP
    D.3.1Product nameRevlimid Lenalidomide
    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.3.9.3Other descriptive nameLenalidomide or Revlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRevlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeImmunomodulatory agent
    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.2.1.1.1Trade name REVLIMID (LENALIDOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, Royaume-Uni
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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/3/04/192
    D.3 Description of the IMP
    D.3.1Product nameRevlimid Lenalidomide
    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.3.9.3Other descriptive nameLenalidomide or Revlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRevlimid or Alpha-3-aminophtalimido glutarimide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeImmunomodulatory agent
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Myélome de novo
    stade DS : III, II, I with one symptomatic bone ogique)
    No sign of cardia insufficiency and echography must schow FEV> 40 %.
    no hepatic insufficiency : bilirubine< 35µmol/L and SGOT,SGPT, alkaline phosphatases lower than 4 N.
    No respiratory insufficiency : DLCO >50 % N.
    no previous kidney insufficiencey non related to the disease and defined bycréatinine >160 µmol/L.
    Sérology HIV-
    Myélome de novo
    De stade DS : III, II, I avec 1 lésion osseuse symptomatique (radiologique)
    Pas de signes cliniques d'insuffisance cardiaque ou coronarienne et au plan échographique FEV> 40 %.
    Pas d’atteinte hépatique : bilirubine< 35µmol/L et des SGOT, des SGPT, des phosphatases alcalines inférieures à 4 N.
    Pas d’atteinte respiratoire : tests ventilatoires et DLCO >50 % N.
    Pas d’atteinte rénale antérieure non liée à la maladie et définie par une créatinine >160 µmol/L.
    Sérologie HIV-
    E.1.1.1Medical condition in easily understood language
    Myélome de novo
    stade DS : III, II, I with one symptomatic bone ogique)
    Myélome de novo
    De stade DS : III, II, I avec 1 lésion osseuse symptomatique (radiologique)

    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to determine efficacy of revlimid to prolong survival without porgression after autograft.
    Déterminer l’efficacité du Revlimid à prolonger la survie sans progression post-greffe.
    E.2.2Secondary objectives of the trial
    - progression free-survial from date of diagnosis
    - overall survival
    - time to progression
    - response analysis
    o the response rate (at least PR)
    o the duration of response (atleast PR)
    o the duration of the complete response (CR)
    o time to the best answer
    o the quantitative variation of the monclonal peak
    - evalutae the long-term tolerance of revlimid consolidation treatment and post-transplant maintenance
    - La survie sans progression à partir de la date du diagnostic
    - La survie globale
    - Le temps jusqu’à progression
    - Analyse de la réponse
    o Le taux de réponse (au moins PR)
    o La durée de réponse (au moins PR)
    o La durée de la réponse complète (CR)
    o Le temps jusqu’à la meilleure réponse
    o La variation quantitative du pic monoclonal

    - Evaluer la tolérance au long cours du Revlimid en traitement de consolidation et d’entretien post-greffe.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4 - CRITERES D’ELIGIBILITE ET D’INCLUSION

    4-1 - Selection
    4-1 - 1 - pre-autograft Period

     novo Myeloma
     In stage DS: III, II, I with one symptomatic bone lesion (radiological)
     Age between 18 and 65 years
     Volunteer affiliated to a social security scheme
     No clinical signs of heart or coronary insufficiency and sonographic plane February> 40%.
     No liver injury bilirubin <35μmol / L and SGOT, SGPT, alkaline phosphatase less than 4 N.
     No respiratory failure: ventilatory tests and DLCO> 50% N.
     No previous renal disease not related to the disease and defined by a creatinine> 160 mmol / L.
     No history of another malignancy except basal cell carcinoma and stage of cervical cancer I.
     Serology HIV-
     Women of childbearing potential should have a serum or urine pregnancy test (done within 7 days before the start of treatment) negative. An effective method of contraception will also be used throughout the duration of treatment (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy).
    4-1 - 2 - Period autograft
     Good general condition (WHO code 2; Appendix 2).
     creatinine <250 mmol / L.
     graft good quality according to the standards of each center (indicative ≥ 5 X 106 CD34 / Kg / 1 for transplant)
     No other exclusion criteria (see diagnosis)
    4-2 - Inclusion in the study (post-transplant randomization)
     Informed consent and patient's written
     post-transplant period ≤ 6 months
     No signs of progression after transplantation (see Annex 3)
     Women of childbearing potential should have a serum pregnancy test (performed within 3 days before the start of treatment) negative. An effective method of contraception will also be used for the duration of maintenance therapy (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy). An additional method of birth control (condom) is highly recommended for the duration of treatment. Treatment should be delivered within 7 days after the completion of this test.
     No severe active infection
     satisfactory haematological reconstitution defined by: PN> 1000 / mm3 and Pads> 75,000 / mm3.
     Bilirubin <35 mmol / l and TGO / TGP / PAL <3N
     creatinine <160 mmol /
    4 - 1 - Sélection
    4 - 1 - 1 - Période pré-autogreffe

     Myélome de novo
     De stade DS : III, II, I avec 1 lésion osseuse symptomatique (radiologique)
     Age compris entre 18 et 65 ans
     Volontaire affilié à un régime de sécurité sociale
     Pas de signes cliniques d'insuffisance cardiaque ou coronarienne et au plan échographique FEV> 40 %.
     Pas d’atteinte hépatique : bilirubine< 35µmol/L et des SGOT, des SGPT, des phosphatases alcalines inférieures à 4 N.
     Pas d’atteinte respiratoire : tests ventilatoires et DLCO >50 % N.
     Pas d’atteinte rénale antérieure non liée à la maladie et définie par une créatinine >160 µmol/L.
     Pas d’antécédent d’autre affection maligne à l'exception du carcinome basocellulaire et du cancer du col de stade I.
     Sérologie HIV-
     Les femmes en âge de procréer doivent avoir un test sérique ou urinaire de grossesse (réalisé dans les 7 jours qui précèdent le début du traitement) négatif. Une méthode de contraception efficace sera également utilisée pendant toute la durée du traitement (contraceptif orale, injectable, transcutané ou implantable, ligature des trompes, dispositif intra-utérin, barrière contraceptive utilisant des spermicides ou vasectomie du partenaire).
    4 - 1 - 2 - Période d’auto-greffe

     Bon état général (code OMS 2 ; annexe 2).
     Créatinine < 250 µmol/L.
     Greffon de bonne qualité en fonction des normes de chaque centre (à titre indicatif ≥ 5 X 106 CD34/Kg / pour 1 greffe)
     Absence tout autre critère d'exclusion (cf. diagnostic)

    4 - 2 - Inclusion dans l’étude (randomisation post-greffe)

     Consentement éclairé et écrit du patient
     Délai post-greffe ≤ 6 mois
     Pas de signes de progression après greffe (cf. annexe 3)
     Les femmes en âge de procréer doivent avoir un test sérique de grossesse (réalisé dans les 3 jours qui précèdent le début du traitement) négatif. Une méthode de contraception efficace sera également utilisée pendant toute la durée du traitement d’entretien (contraceptif orale, injectable, transcutané ou implantable, ligature des trompes, dispositif intra-utérin, barrière contraceptive utilisant des spermicides ou vasectomie du partenaire). Une méthode de contraception additionnelle (préservatif) est fortement recommandée pendant toute la durée du traitement. Le traitement devra être dispensé dans les 7 jours qui suivent la réalisation de ce test.
     Pas d’infection sévère active
     Reconstitution hématologique satisfaisante définie par : PN >1000/mm3 et Plaquettes> 75 000/mm3.
     Bilirubine< 35 µmol/l et TGO/TGP/PAL< 3N
     Créatinine< 160 µmol/l.

    E.4Principal exclusion criteria
    Cfr Inclusion Criteria
    Cfr Inclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    Complete blood counts will be monitored weekly for the first 2 months and then one time every 15 days during the following 2 months and 1 monthly thereafter. The dose of Revlimid will be tailored to the figures of PN and platelets:
    if with 1 tablet per day, the number of PN is less than 500 / mm3 or the platelet count is less than 25,000 / mm3, treatment should be interrupted and resumed at a dose of 1 tablet (if PN and Plaq are required levels). If the number of PN is again less than 500 / mm3 or the platelet count is less than 25,000 / mm3, the treatment will be finalized.
    At any time, the protocol may be interrupted: * at the patient's request (withdrawal of consent) * if * increase * in case of death of sight * new cancer treatment
    Unblinding must be requested by mail, fax or mail to the coordinator investigator (fax: 05 61 77 94 62).
    L’hémogramme sera surveillé une fois par semaine pendant les 2 premiers mois, puis 1 fois tous les 15 jours pendant les 2 mois suivants et 1 fois par mois ensuite. La posologie du Revlimid sera adaptée aux chiffres de PN et de plaquettes :
    si avec 1 comprimé par jour, le chiffre des PN est inférieur à 500/mm3 ou si le chiffre des plaquettes est inférieur à 25 000/mm3, le traitement sera interrompu et repris à la dose de 1 comprimé (si les PN et les Plaq sont aux niveaux requis). Si le chiffre des PN est de nouveau inférieur à 500/mm3 ou si le chiffre des plaquettes est inférieur à 25 000/mm3, le traitement sera définitivement arrêté.

    A tout moment, le protocole pourra être interrompu :
    * à la demande du patient (retrait du consentement)
    * en cas de progression
    * en cas de décès
    * perte de vue
    * nouveau traitement anti-cancéreux

    La levée d’aveugle devra être demandée par courrier, fax ou mail à l’investigateur coordonnateur (fax : 05 61 77 94 62).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Complete blood counts will be monitored weekly for the first 2 months and then one time every 15 days during the following 2 months and 1 monthly thereafter. The dose of Revlimid will be tailored to the figures of PN and platelets:
    If the number of PN is again less than 500 / mm3 or the platelet count is less than 25,000 / mm3, the treatment will be finalized.
    At any time, the protocol may be interrupted: * at the patient's request (withdrawal of consent) * if * increase * in case of death of sight * new cancer treatment
    L’hémogramme sera surveillé une fois par semaine pendant les 2 premiers mois, puis 1 fois tous les 15 jours pendant les 2 mois suivants et 1 fois par mois ensuite. La posologie du Revlimid sera adaptée aux chiffres de PN et de plaquettes :
    Si le chiffre des PN est de nouveau inférieur à 500/mm3 ou si le chiffre des plaquettes est inférieur à 25 000/mm3, le traitement sera définitivement arrêté.A tout moment, le protocole pourra être interrompu à la demande du patient (retrait du consentement), en cas de progression, en cas de décès, perte de vue, nouveau traitement anti-cancéreux
    E.5.2Secondary end point(s)
    - progression free-survial from date of diagnosis
    - overall survival
    - time to progression
    - response analysis
    o the response rate (at least PR)
    o the duration of response (atleast PR)
    o the duration of the complete response (CR)
    o time to the best answer
    o the quantitative variation of the monclonal peak
    - evalutae the long-term tolerance of revlimid consolidation treatment and post-transplant maintenance
    - La survie sans progression à partir de la date du diagnostic
    - La survie globale
    - Le temps jusqu’à progression
    - Analyse de la réponse
    o Le taux de réponse (au moins PR)
    o La durée de réponse (au moins PR)
    o La durée de la réponse complète (CR)
    o Le temps jusqu’à la meilleure réponse
    o La variation quantitative du pic monoclonal

    - Evaluer la tolérance au long cours du Revlimid en traitement de consolidation et d’entretien post-greffe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Planned analyses: 2 (interim and final analyses)
    analyse planifiée : 2 (interim et final analyses)
    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 Yes
    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 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) 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 Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    placebo
    placebo
    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.8.2.4Number of treatment arms in the trial2
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Belgium
    France
    Switzerland
    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
    Last visit of last patient.
    dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 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 2007-03-08. Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 614
    F.4.2.2In the whole clinical trial 614
    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)
    Normal care of myeloma's pathology.
    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 Decision2007-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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