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    Summary
    EudraCT Number:2013-003190-99
    Sponsor's Protocol Code Number:38RC13.410
    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:2015-09-25
    Trial results View 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 number2013-003190-99
    A.3Full title of the trial
    Evaluation of the use of an oral direct anti-Xa anticoagulant, Apixaban in prevention of venous thromboembolic disease in patients treated with IMiDs during myeloma: a pilot study
    Evaluation de l’utilisation d’un anticoagulant anti-Xa direct oral, Apixaban, dans la prévention de la maladie thromboembolique veineuse chez les patients traités par IMiDs au cours du myélome : étude pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the use of an oral direct anti-Xa anticoagulant, Apixaban in prevention of venous thromboembolic disease in patients treated with IMiDs during myeloma: a pilot study
    Evaluation de l’utilisation d’un anticoagulant anti-Xa direct oral, Apixaban, dans la prévention de la maladie thromboembolique veineuse chez les patients traités par IMiDs au cours du myélome : étude pilote
    A.3.2Name or abbreviated title of the trial where available
    MYELAXAT
    MYELAXAT
    A.4.1Sponsor's protocol code number38RC13.410
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Grenoble
    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 supportCelgene International
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Grenoble
    B.5.2Functional name of contact pointSABBAH GUILLAUME
    B.5.3 Address:
    B.5.3.1Street AddressDRCI Pavillon Saint Eynard CS 10217
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number330476768455
    B.5.5Fax number330476765221
    B.5.6E-mailMCoutard@chu-grenoble.fr
    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 Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Meyer Squib
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Multiple myeloma
    Myélome multiple
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Myélome multiple
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    To evaluate:
    - the incidence of venous thromboembolic event (VTE)
    - the incidence of hemorrhagic complications,
    In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day
    Evaluer:
    - l’incidence réelle des complications thromboemboliques veineuses
    - l’incidence réelle des complications hémorragiques,
    dans une population de patients atteints de myélome traités par IMiDs et requérants une thromboprophylaxie sur une période de 6 mois, en utilisant une thromboprophylaxie antiXa directe par Apixaban 2.5 mg x2/j.
    E.2.2Secondary objectives of the trial
    - to determine the incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the thombotic risk stratification of patients (low or high risk)
    - to determine the incidence of venous thromboembolic complications, symptomatic and asymptomatic, according to the time of treatment with IMiDs (diagnosis or relapse)
    - to determine the incidence of major and clinically relevant non major bleeding according to the thombotic risk stratification of patients (low or high risk)
    - to determine the incidence of arterial cardiovascular events (myocardial infarction, ischemic stroke, TIA)
    Déterminer l’incidence des complications thromboemboliques veineuses, symptomatiques et asymptomatiques, selon la stratification du risque thrombotique des patients (bas ou haut risque)
    - Déterminer l’incidence des complications thromboemboliques veineuses, symptomatiques et asymptomatiques selon l’indication du traitement par IMiDs, première ligne ou rechute
    - Déterminer l’incidence des complications hémorragiques graves et non graves cliniquement pertinentes selon la stratification du risque thrombotique des patients (bas ou haut risque).
    - Déterminer l’incidence des accidents cardiovasculaires artériels (Infarctus du myocarde, AVC, AIT)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients (men/women) aged more than 18 years
    • All consecutive patients, with myeloma, in first-line treatment or in relapse, who are treated
    - With IMiDs (MPT, Melphalan -Prednisone -Thalidomide ; Lenalidomide - Dexamethasone).
    AND
    - who require prevention of venous thromboembolic events with Aspirin or Low molecular Weight Heparin (LMWH) for a minimum duration of 6 months
    At least, 2/3 of patients will be treated with Lenalidomide-Dexamethasone.
    • Written informed consent
    • Patients affiliated to the French social security system or equivalent

    • Patient (homme/femme) âgé d’au moins 18 ans
    - Tous les patients consécutifs, atteints de myélome, en première ligne ou en rechute, traités :
    o par ImiDs (selon le schéma MPT, Melphalan-Prednisone-Thalidomide ; Lenalidomide - Dexamethasone)
    ET
    o Requérant une prévention des évènements thromboemboliques veineux par un traitement par Aspirine ou HBPM pour une durée minimale de 6 mois.
    (au moins 2/3 des patients recevront un traitement par Lenalidomide-Dexamethasone.)

    • Volontaire pour participer à l’étude, ayant signé le formulaire de consentement après information adéquate et remise de la note d’information,
    • Personne affiliée à la sécurité sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    • Patient who needs curative anticoagulant treatment (heparin, LMWH, vitamin K antagonists, Dabigatran, Rivaroxaban, Apixaban) for an associated disorder (mechanical valve, atrial fibrillation or venous thromboembolic disease in the previous 6 months).
    • Patient who needs preventive treatment with an anticoagulant in a post-operative context
    • Patient who needs anti-platelet treatment (Aspirin, Clopidogrel, Prasugrel, Ticagrelor or dual anti-platelet therapy )
    • Patient with active bleeding or at a high risk of bleeding (ulcer disease, intracranial bleeding in the previous 6 months, uncontrolled hypertension)
    • Patient having undergone a surgical intervention within the past 30 days likely to expose them to an haemorrhagic risk
    • Active hepatic disease (hepatitis, cirrhosis)
    • Severe renal insufficiency (creatinine clearance using the Cockcroft equation < 30 ml/mn)
    • Known allergic reaction to Apixaban
    • Contraindication to the use of an anticoagulant treatment
    • Prohibited concomitant treatment
    - inhibitors of CYP3A4 and P-gp : azole antimycotic agents (ketoconazole, itraconazole, voriconazole, posaconazole), inhibitors of HIV protease (ritonavir, indinavir, nelfinavir, atazanavir, saquinavir), specific macrolide antibiotics (clarithromycine, telithromycine)
    - other antithrombotic treatment : salicylate derivates (aspirin, products containing aspirin), antiplatelet therapy, heparin (unfractionated heparin, low molecular weight heparin, danaparoide sodique, fondaparinux), hirudines, oral anticoagulants (vitamin K antagonists, rivaroxaban, dabigatran)
    • Patient with AST or ALT rate > 3 times upper limit of normal
    • Patient with Bilirubin rate > 1.5 times upper limit of normal
    • Patient with Platelets rate < 75 G/l
    • Patient with Creatinine Clearance (Cockcroft) < 30 ml/mn
    • Incidental finding of a proximal Deep Venous Thrombosis on the screening ultrasound
    • Patients refusing or unable to give a written consent of information
    • Patient unable to comply with the protocol requirement, in the investigator’s opinion
    • Life expectancy less than 6 months
    • Incarcerated patients
    • Pregnancy or possibility of pregnancy within 6 months
    • Females of childbearing potential without reliable contraception
    • Ecog ≥ 2
    • Patient justifiant un traitement par anticoagulant curatif (Héparine, HBPM, AVK, dabigatran, rivaroxaban, apixaban) pour une affection associée (Fibrillation auriculaire, valves mécaniques, thrombose veineuse profonde proximale ou embolie pulmonaire documentée depuis moins de 6 mois)
    • Patient justifiant un traitement par anticoagulant préventif dans un contexte post-opératoire
    • Patient justifiant un traitement antiagrégant plaquettaire (Aspirine, Clopidogrel, Prasugrel, Ticagrelor, double antiagrégation)
    • Patient avec un saignement actif ou un haut risque hémorragique (ex : ulcère actif, accident vasculaire cérébral hémorragique récent dans les 6 mois, HTA non contrôlée)
    • Patient ayant eu une intervention chirurgicale dans les 30 jours pouvant exposer à un risque hémorragique
    • Patient présentant une affection hépatique active (hépatite, cirrhose)
    • Patient présentant une affection rénale sévère (clairance de créatinine selon Cockroft < 30 ml/mn)
    • Patient présentant une hypersensibilité connue à l’apixaban
    • Contre indication à l’utilisation d’un anticoagulant
    • Patient traité par :
    - inhibiteurs du CYP3A4 et de la P-gp : antimycosiques azolés (ex : kétoconazole, itraconazole, voriconazole, posaconazole), inhibiteurs de la protéase du VIH (ritonavir, indinavir, nelfinavir, atazanavir, saquinavir), certains macrolides (clarithromycine, telithromycine)

    - autres antithrombotiques : dérivés salicylés (aspirine et produits contenant de l’aspirine), antiagrégants plaquettaires, héparines (Héparine non fractionnée, HBPM, Fondaparinux, danaparoide sodique), hirudines, anticoagulants oraux (AVK, rivaroxaban, dabigatran)
    • Patient avec un taux d’ASAT ou ALAT > 3x limites supérieures de la normale
    • Patient avec un taux de bilirubine > 1.5x limite supérieure de la normale
    • Patient avec un taux de plaquettes < 75 G/l à l’inclusion
    • Patient présentant une clairance de créatinine selon Cockcroft < 30 ml/mn
    • Découverte fortuite d’une thrombose proximale sur l’écho doppler du screening
    • Patient incapable de se soumettre aux recommandations protocolaires selon l’avis de l’investigateur
    • Espérance de vie inférieure à 6 mois
    • Grossesse déclarée ou envisagée dans les 6 mois*
    • Femme en âge de procréer sans contraception fiable (implant contraceptif, dispositif intra-utérin 5DIU au lévonorgestrel, acétate de médroxyprogestérone retard, stérilisation tubaire, rapports sexuels exclusivement avec un partenaire ayant subi une vasectomie (prouvée par 2 spermogrammes négatifs), pilule progestative inhibant l’ovulation * )
    • Ecog ≥2
    • Personne privée de liberté par décision judiciaire ou administrative, personne faisant l’objet d’une mesure de protection légale.
    (*l’utilisation des IMids est de toute façon soumise à un plan de prévention des grossesses (PGR) dans le cadre de son utilisation commerciale)
    E.5 End points
    E.5.1Primary end point(s)
    - Total VTE (fatal or non fatal pulmonary embolism, symptomatic distal or proximal DVT of lower limbs, and asymptomatic proximal DVT detected by bilateral compression ultrasound) and VTE-related death.

    - Major and clinically relevant non major bleeding, defined according to International Society of Thrombosis and haemostasis (Schulman 2005).
    - Complications thromboemboliques veineuses totales (EP fatales et non fatales, TVP symptomatiques des membres inférieurs distales et proximales, TVP proximales asymptomatiques détectées par écho-doppler), décès liés à la maladie thromboembolique
    - Complications hémorragiques graves et non graves cliniquement pertinentes définies selon la Société Internationale de thrombose et d’hémostase
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    Incidence of the complications venous, symptomatic and asymptomatic thromboemboliques, according to the risk thrombotique of the patients ( low or high risk), stratified according to the IMWG.
    - Incidence of the complications venous, symptomatic and asymptomatic thromboemboliques according to the indication of the treatment(processing) by IMiDs, in the front line or in relapse
    - Incidence of the grave hemorrhagic complications, and not grave clinically relevant according to the risk thrombotique patients ( low or high risk), stratified according to the IMWG.
    - Incidence of the arterial cardiovascular accidents, is myocardial infarction (Acute(Sharp) Coronary Syndrome with or without gap ST and Troponine +), ischemic cerebral vascular Accident (TDM or MRI).
    Incidence des complications thromboemboliques veineuses, symptomatiques et asymptomatiques, selon le risque thrombotique des patients (bas ou haut risque), stratifié selon l’IMWG.
    - Incidence des complications thromboemboliques veineuses, symptomatiques et asymptomatiques selon l’indication du traitement par IMiDs, en première ligne ou en rechute
    - Incidence des complications hémorragiques graves, et non graves cliniquement pertinentes selon le risque thrombotique des patients (bas ou haut risque), stratifié selon l’IMWG.
    - Incidence des accidents cardiovasculaires artériels, soit infarctus du myocarde (Syndrome Coronarien Aigu avec ou sans décalage ST et Troponine+), Accident vasculaire cérébral ischémique (TDM ou IRM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) 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 concerned20
    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 No
    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
    LVLS
    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 months31
    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 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.1.2.1Number of subjects for this age range: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state105
    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)
    none
    non
    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 Decision2013-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-08
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