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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2006-003563-31
    Sponsor's Protocol Code Number:: 26866138CAN2021
    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:2008-10-21
    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 number2006-003563-31
    A.3Full title of the trial
    Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom’s Macroglobulinemia: A multicenter Trial of the European Myeloma Network
    A.3.2Name or abbreviated title of the trial where available
    protocole BDR
    A.4.1Sponsor's protocol code number: 26866138CAN2021
    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 SponsorCentre Hospitalier de Lens
    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 AuthorisationEuropean Union
    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.3.11 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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemabthera 500 mg
    D.3.2Product code RO045-2294
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemabthera 100mg
    D.3.2Product code RO045-2294
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Macroglobulinémie de Waldenström au moment de l’initiation du traitement de 1e ligne.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer le taux de réponse [complète (CR) ou partielle (PR) ou minime (MR)] à l’issue d’un traitement par Bortezomib Dexamethasone et Rituximab chez les patients souffrant d’une maladie de Waldenström non antérieurement traitée.
    E.2.2Secondary objectives of the trial
    Déterminer le délai de progression après un traitement par BDR.Evaluer la sécurité et la tolérance d’un traitement par Bortezomib, dexamethasone et Rituximab chez les patients porteurs de maladie de Waldenström
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Maladie de WALDENSTRÖM histologiquement prouvée selon les recommandations du consensus du deuxième Worksop International sur la maladie de WALDENSTRÖM.
    ·Absence de traitement antérieur systémique pour la maladie de WALDENSTRÖM. Des plasmaphérèses afin de contrôler l’hyperviscosité sont autorisées, dans ce cas la réponse sera évaluée en prenant pour taux de base (initial) du composant monoclonal, la concentration observée avant ces plasmaphérèses, si cette valeur est plus élevée que celle observée avant traitement.
    ·Les patients doivent avoir au moins l’un des critères suivants de mise en route du traitement initial tel que défini par les recommandations du deuxième Workshop International sur la maladie de WALDENSTRÖM :
    o fièvre au long cours, sueurs nocturnes, amaigrissement, fatigue.
    o Hyperviscosité.
    o Adénopathies soit symptomatiques, soit volumineuses ( plus de 5 cm de diamètre maximal).
    o Hépatomégalie ou splénomégalie symptomatique.
    o Orgamégalie symptomatique ou infiltration viscérale ou tissulaire.
    o Neuropathie périphérique en rapport avec la maladie de WALDENSTRÖM.
    o Cryoglobulinémie symptomatique.
    o Anémie par agglutines froides.
    o Anémie hémolytique auto-immune ou thrombopénie.
    o Néphropathie en rapport avec la maladie de WALDENSTROM.
    o Amylose en rapport avec la maladie de WALDENSTRÖM.
    o Hémoglobine inférieure ou égale à 10 g/dl.
    o Taux de plaquettes strictement inférieur à 100.000/mm3, 109/l.
    o Composant monoclonal supérieur à 50 g/l même sans symptôme.
    · Autres critères :
    o maladie de Waldenström CD20 positive selon les constatations d’une immunohistochimie médullaire antérieurement réalisée ou d’une analyse de cytométrie réalisée dans les trois mois avant l’inclusion.
    o Indice de performance Karnofski supérieur à 60.
    o Espérance de vie supérieure à 3 mois.
    o Taux de plaquettes supérieur à 50, 109/l et taux de concentration de polynucléaires neutrophiles supérieurs à 0.75, 109/l.
    o Critère de sécurité pré-thérapeutique observé lors de la viste d’évaluation réalisée moins de 28 jours avant l’inclusion :
    1. ALAT AST ( SGOT) inférieure à 3 fois la limite supérieure de la normale du laboratoire.
    2. ALT (GPT) inférieure à 3 fois la limite supérieure de la normale du laboratoire.
    3. Bilirubine totale inférieure à 2 fois la limite supérieure du laboratoire à moins qu’elle ne soit clairement en rapport avec la maladie.
    4. Clairance de la créatinine mesurée ou calculée supérieure à 30 ml/mn.
    5. Natrémie supérieure à 130 mol/l.
    · Obtention d’un consentement éclairé, écrit et volontaire avant la réalisation de toute procédure en rapport avec cette étude même en dehors de la réalisation du traitement avec la parfaite compréhension que ce consentement pouvait être retiré par le sujet à tout moment sans préjudice pour sa prise en charge médicale ultérieure.
    E.4Principal exclusion criteria
    ·Traitement systémique antérieur de la maladie de WALDENSTRÖM (les plasmaphérèses sont autorisées).
    ·Infarctus du myocarde dans les 6 mois avant l’inclusion ou insuffisance cardiaque de classe III ou IV de la NYHA, ou angine non contrôlée ou arythmie ventriculaire sévère non contrôlée ou manifestation électrocardiographique d’ischémie aiguë ou de troubles de conduction évolutive avant.
    Avant l’entrée dans l’étude, les anomalies à l’ECG doivent être documentées par l’investigateur au moment de la visite d’ évaluation comme non significatif au plan médical.
    ·L’hypersensibilité à la DEXAMETHASONE, au BORTEZOMIB, au borate ou au Mannitol.
    ·Maladies médicales ou psychiatriques sévères susceptibles d’altérer la participation à cette étude clinique.
    ·Amylose cardiaque.
    ·Neuropathie périphérique ou douleurs neuropathiques de grade II selon les critères définis par la version 3 du NCI CTCAE.
    ·Femmes enceintes.
    ·Les femmes qui souhaitent poursuivre un allaitement, et femmes en âge de procréer qui n’acceptent pas la prise d’une méthode contraceptive efficace pendant toute la durée de l’essai et dans les six mois suivants. Les hommes qui ne s’engagent pas à ne pas procréer pendant toute la période de traitement et les six mois consécutifs.
    E.5 End points
    E.5.1Primary end point(s)
    Déterminer le taux de réponse [complète (CR) ou partielle (PR) ou minime (MR)] à l’issue d’un traitement par Bortezomib Dexamethasone et Rituximab chez les patients souffrant d’une maladie de Waldenström non antérieurement traitée.
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    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 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) 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 2008-10-21. 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 61
    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)
    sans objet
    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 Decision2008-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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