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    The EU Clinical Trials Register currently displays   36088   clinical trials with a EudraCT protocol, of which   5931   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004218-42
    Sponsor's Protocol Code Number:P060207
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-07
    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 number2006-004218-42
    A.3Full title of the trial
    Essai thérapeutique de phase IIA évaluant l'efficacité du Bortezomib (velcade) chez les patients atteints de la maladie de Waldenstrom en phase avancée
    A.3.2Name or abbreviated title of the trial where available
    WM2
    A.4.1Sponsor's protocol code numberP060207
    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 INTERNATIONAL NV
    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 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 INNBortézomib
    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 No
    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 nameDEXAMETHASONE AP-HP
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexaméthasone Acétate
    D.3.9.1CAS number 1177-87-3
    D.3.9.3Other descriptive namePrednisolone F acetate
    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 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
    Maladie de Waldenstrom réfractaire ou en rechute après une ou deux lignes de traitement ayant comporté des alkylants et/ou des analogues de purine et/ou un anticorps monoclonal seul ou en association.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10054695
    E.1.2Term Macroglobulinémie de Waldenström
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimer l'efficacité du bortezomib chez des patients ayant une MW en rechute ou réfractaire : Evaluation de la réponse au bortezomib en monothérapie.
    E.2.2Secondary objectives of the trial
    - Evaluation de la réponse au bortezomib en association à la Dexméthasone pour des patients résistants au bortezomib seul.
    - Durée de la réponse.
    - Amélioration des paramètres hématologiques.
    - Toxicité.
    - Qualité de vie.
    - Survie sans évènement.
    - Survie globale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Maladie de Waldenstrom réfractaire ou en rechute après 1 ou 2 lignes de traitement, avec existence d'au moins un des 6 critères suivants :
    * Signes généraux : fièvre > 38 degré depuis plus de 5 jours, sueurs nocturnes abondantes, altération de l'état général (amaigrissement > 10% du poids du corps).
    * Mauvais état général (PS > 1) qui ne peut être expliqué autrement que par l'hémopathie.
    * Au moins une cytopénie : Hb < 10 g/dl, et/ou PN < 1,5 (mais > 1) x 10 E+9/L , et/ou plaquettes < 150 (mais > 100) x 10 E+9/L.
    * Complications liées à l'immunoglobuline monoclonale Ig M : Physico-chimiques (hyperviscosité, cryoglobuline de type I symptomatique, troubles de l'hémostase sévère), auto-immunes (agglutinines froides, cryoglobuline de type II symptomatique, etc ...).
    * Forte masse tumorale : Masse tumorale > 7 cm, et/ou présence de plus de 3 ganglions de diamètre > 3 cm, et/ou épanchement séreux, et/ou syndrome compressif, et/ou splénomégalie symptomatique.
    * Augmentation de l'immunoglobuline monoclonale de plus de 25 % à partir de 20 g/L ou progression de la masse tumorale > 25 %.
    - Critères morphologiques et immunophénotypiques (cytométrie de flux sur moelle et sang) :
    * Infiltration de la moelle par des petits lymphocytes matures et lymphoplasmocytes.
    * Immunoglobuline monoclonale IG M quelque soit sa concentration.
    * Population tumorale avec antigènes CD19 +, CD 20 +, CD 5 -, CD 10 -, CD 23 -
    * Population tumorale morphologiquement compatible (soit CD 5 +, soit CD 23 +) après avoir éliminé les autres diagnostics différentiels.
    - Age > 18 ans.
    - Espérance de vie > 3 mois.
    - ECOG à 0-1-2.
    - PN > 1 x 10 E+9/L.
    - Plaquettes > 100 10 E+9/L.
    - Clairance de la crétinine > 40 ml/mn.
    - Bilirubine, ASAT / ALAT < ou = 2 N.
    - Test de grossesse négatif une semaine avant le traitement pour les femmes en âge de procréer, et les femmes dont la ménopause est inférieure à 2 ans.
    - Contraception efficace pour les hommes et les femmes en âge de procréer pendant le traitement et les 6 mois qui suivent l'arrêt du traitement.
    - Signature du consentement informé.
    - Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Cancer depuis moins de 5 ans sauf épithélioma baso-cellulaire de la peau et carcinome in situ du col utérin.
    - Femme enceinte, ou allaitante.
    - Béta HCG positive.
    - Infection évolutive non contrôlée.
    - Transformation en lymphome à grandes cellules.
    - Déficience ne permettant pas une bonne compréhension des impératifs de l'essai.
    - Sérologie VIH positive.
    - Hépatite C ou B active.
    - Patient ne pouvant pas être suivi de façon régulière.
    - Neuropathie périphérique > grade I.
    - Hypertension difficile à contrôler.
    - Diabète sévère.
    - Insuffisance respiratoire sévère avec hypoxémie.
    - Insuffisance cardiaque avec NYHA grade III/IV, fraction éjection ventriculaire G < 50% ou raccourcissement < 30%, infarctus du myocarde dans les 6 mois précédant l'étude.
    - Syndrome de Richter.
    - Insuffisance hépatocellulaire sévère
    E.5 End points
    E.5.1Primary end point(s)
    Réponse évaluée à 2, 4, 6 mois :
    - Succès : Diminution de l'Ig M > 25 % sur l'électrophorèse.
    - Echec : réponse < 25 %, stabilité ou progression.
    - Durée de la réponse.
    - Survie globale.
    - Survie sans progression.
    - - Survie sans évènement.
    - Tolérance.
    - Qualité de vie (questionnaire QLQ-C30).
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned6
    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 years5
    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) 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 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 2007-12-07. 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 state34
    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 Decision2008-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-09
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