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    Summary
    EudraCT Number:2009-017926-38
    Sponsor's Protocol Code Number:P081226
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-06-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-017926-38
    A.3Full title of the trial
    Traitement de la nephropathie à cylindres myelomateux. MYRE
    A.3.2Name or abbreviated title of the trial where available
    MYRE
    A.4.1Sponsor's protocol code numberP081226
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number131269
    D.3 Description of the IMP
    D.3.1Product nameVELCADE
    D.3.4Pharmaceutical form Powder for solution for injection
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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.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 Solumédrol
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZIER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSolumédrol
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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.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 Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEndoxan
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCyclophosphamide anhydre
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 4
    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 Thalidomide
    D.2.1.1.2Name of the Marketing Authorisation holderCelgen Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA135685
    D.3 Description of the IMP
    D.3.1Product nameThalidomide
    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 INNThalidomide Celgene
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Myélome multiple compliqué d'insuffisance rénale par néphropathie à cylindre myélomateux.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10029151
    E.1.2Term Traitement de la nephropathie à cylindres myelomateux
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l'effet sur la fonction rénale de malades ayant un myélome multiple (MM), compliqué d'insuffisance rénale par néphropathie à cylindres myélomateux (NCM) :
    - pour les malades ne nécessitant pas l'épuration extra-rénale de renforcer la chimiothérapie de référence (Bortezomib-Dexamethasone) par le Cyclophosphamide.
    - pour les malades nécessitant une épuration extra-rénale (EER) : d'une hémodialyse soit par la membrane de dialyse Gambro HCO, soit par une membrane traditionnelle, associée à une chimiothérapie par Bortezomib et Dexamethasone.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sera potentiellement éligible tout malade, présentant les critères d'inclusion suivant :
    1. Patients ? 18 ans
    2. Ayant une immunoglobuline (Ig) monoclonale quel qu'en soit l'isotype et/ou une chaîne légère isolée, sérique et/ou urinaire.
    3. Avec insuffisance rénale définie par une créatinine sérique > 170µmol/l et/ou un DFG < 40 ml/min/1.73 m2 (MDRD)
    4. N'ayant pas reçu plus d'une cure d'une chimiothérapie habituellement utilisée en traitement du myélome ou d'une autre hémopathie lymphoïde
    5. Ayant été informé et ayant donné son consentement écrit
    6. Affilié à un régime de sécurité sociale

    Peut être randomisé tout malade :
    1. Présentant une insuffisance rénale définie par une créatininémie > 170 µmol/l et/ou un DFG < 40 ml/min/1.73 m2
    2. Liée à une NCM probable (protéinurie constituée à < 30% d'albumine, avec albumine < 500 mg/j et rapport albumine/créatinine urinaire < 300 mg/g), ou, à chaque fois que le contexte clinique ou l'analyse de la protéinurie le justifie, prouvée histologiquement. En revanche, la présence de dépôts amorphes péri-tubulaires de chaîne légère monoclonale (LCDD) associés à une NCM ne contre-indique pas la randomisation, à condition qu'il n'y ait pas de lésions glomérulaires associées.
    3. Compliquant un myélome multiple. Le diagnostic de MM implique la mise en évidence d'une infiltration plasmocytaire médullaire. Le myélome doit être excrétant i.e. avec :
    - présence d'une immunoglobuline monoclonale sérique décelable par électrophorèse
    - et/ou des chaînes légères monoclonales urinaires à un taux supérieur à 0.5g/24h
    - et/ou un taux d'une des chaînes légères libres sériques au moins 2 fois supérieur aux valeurs normales avec rapport kappa/lambda anormal
    4. Ayant été informé et ayant donné leur consentement écrit pour l'étude avec chimiothérapie seule ou pour l'étude avec chimiothérapie et hémodialyse selon le cas.
    5. Avec un hémogramme montrant :
    Nombre absolu de neutrophiles sup ou égal à 1.0 x 10^9/l ET Plaquettes ? 70 x 10^9/l
    E.4Principal exclusion criteria
    Ne seront pas randomisés, les patients présentant les critères de non inclusion ci-dessous :
    1. Amylose AL prouvée histologiquement
    2. Toute condition médicale, toute anomalie biologique, ou pathologie psychiatrique susceptible d'empêcher le patient de signer un formulaire de consentement éclairé
    3. Insuffisance rénale chronique préalable connue et sévère (eDFG < 30 ml/min/1.73 m2) (cf. annexe 1) non liée au MM
    4. Pathologie associée grave, néoplasique (autre que le MM) ou autre (sauf cancer de la peau localisé de type carcinome baso-cellulaire ou épidermoïde)
    5. Sérologie HIV positive, hépatite B ou C évolutive, herpes, varicelle, zona
    6. Malade ayant reçu, en plus des bolus de Solumedrol prévus durant la phase d'inclusion, plus d'une cure d'une chimiothérapie habituellement utilisée en traitement du myélome, et/ou une corticothérapie équivalant à plus de 160 mg de Dexamethasone, ou à plus de 1 mg/kg/j de Prednisone pendant un mois.
    7. Insuffisance hépato-cellulaire, cytolyse (SGPT > 10N) et/ou cholestase (phosphatases alcalines ou GT > 5N) persistantes
    8. Neuropathie périphérique sévère préexistante
    9. Contre-indication aux fortes doses de corticoïdes
    10. Contre-indication au traitement par Bortezomib, en particulier pulmonaire et péricardique.
    11. Pas de surveillance régulière possible
    12. Pour les femmes en âge de procréer, test de grossesse positif ou allaitement en cours
    E.5 End points
    E.5.1Primary end point(s)
    Critère de jugement principal
    - Amélioration de la fonction rénale après 3 cures de chimiothérapie protocolaire (au plus tard 3 mois après la randomisation), évaluée :
    - Pour les patients dialysés : par le taux de sortie de dialyse
    - Pour les patients se présentant avec une insuffisance rénale aiguë ne nécessitant pas la dialyse : par l'obtention d'une valeur de la créatinémie ? 170 µmol/l et/ou d'un DFG estimé selon l'équation MDRD modifiée ? 40 ml/min/1.73m2 (critère correspondant à un niveau de fonction rénale compatible avec un traitement intensif du myélome)

    Critères de jugement secondaire
    - Amélioration de la fonction rénale après 1 cure, après la fin de la chimiothérapie protocolaire, à 6 mois et à 1 an
    - Récupération rénale complète, définie par le retour à la fonction rénale antérieure si connue, ou par un eDFG ? 60 ml/min/1.73m2 après 1 cure, après 3 cures, à la fin de la chimiothérapie protocolaire, à 6 mois et à 1 an
    - Evolution de la fonction rénale, évaluée par le débit de filtration glomérulaire estimé (eDFG) après 1 cure, après 3 cures, à la fin de la chimiothérapie protocolaire, à 6 mois et à 1 an
    - Réponse hématologique après 1 et 3 cures, à la fin de la chimiothérapie protocolaire, et à 1 an
    - Survie sans évènement et survie sans rechute, délai de reprise d'un traitement
    - Survie globale à 1 an
    - Tolérance, en particulier hématologique et neurologique
    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) 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 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.8.4.1Number of sites anticipated in Member State concerned51
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 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 state284
    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 Decision2010-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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