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    Summary
    EudraCT Number:2012-005804-16
    Sponsor's Protocol Code Number:1256803
    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:2013-04-22
    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 number2012-005804-16
    A.3Full title of the trial
    Front-line therapy with Carfilzomib, Lenalidomide, and Dexamethasone (CRd) induction followed by autologous stem cell transplantation, CRd consolidation and Lenalidomide maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 years old : a phase II study of the Intergroupe Francophone du Myélome (IFM)
    Traitement de première ligne par Carfilzomib, Lenalidomide et Dexamethasone (CRd) en induction suivi par une autogreffe de cellules souches, un traitement de consolidation par CRd et un entretien par Lenalidomide chez les patients de ≤ 65 ans atteints de Myélome Multiple de novo : une étude de phase II de l’Intergroupe Francophone du Myélome (IFM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Front-line therapy with Carfilzomib, Lenalidomide, and Dexamethasone (CRd) induction followed by autologous stem cell transplantation, CRd consolidation and Lenalidomide maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 years old : a phase II study of the Intergroupe Francophone du Myélome (IFM)
    Traitement de première ligne par Carfilzomib, Lenalidomide et Dexamethasone (CRd) en induction suivi par une autogreffe de cellules souches, un traitement de consolidation par CRd et un entretien par Lenalidomide chez les patients de ≤65 ans atteints de Myélome Multiple de novo : une étude de phase II de l’Intergroupe Francophone du Myélome (IFM)
    A.3.2Name or abbreviated title of the trial where available
    IFM CRd
    Etude pilote IFM CRd
    A.4.1Sponsor's protocol code number1256803
    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 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 supportOnyx
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Toulouse
    B.5.2Functional name of contact pointMarie Elise Llau
    B.5.3 Address:
    B.5.3.1Street Address2 rue viguerie -Hôtel Dieu
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.5Fax number33(0)561778411
    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) 25mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited,
    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 Yes
    D.2.5.1Orphan drug designation numberMM:EU/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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) 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.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 CARFILZOMIB
    D.2.1.1.2Name of the Marketing Authorisation holderOnyx pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/08/548
    D.3 Description of the IMP
    D.3.1Product nameCARFILZOMIB
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNCARFILZOMIB
    D.3.9.1CAS number 868540-17-4
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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) 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 Yes
    D.2.5.1Orphan drug designation numberMM:EU/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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) 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
    Myelome Multiple
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    Myelome Multiple
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This phase II study is designed to determine whether induction and consolidation treatment with 2 x 4 cycles of Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.
    The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy
    Évaluer le taux de RC stringente à la fin du traitement de
    consolidation.
    E.2.2Secondary objectives of the trial
    -Determine the safety and tolerability of the drug combination in this patient population as induction and consolidation therapy.
    -Evaluate the sCR, CR, VGPR and PR rates after induction, HDM with ASCT, consolidation , during and after maintenance
    -Evaluate the overall response rate, time to response, progression free survival, the overall survival, time to progression and duration of response.
    -Evaluate the feasibility and quality of the peripheral stem cell collection.
    - Déterminer l'innocuité et la tolérance de l’association CRd en
    induction et en traitement de consolidation
    - Évaluer les taux de sRC, RC, RP et les taux TBRP après l'induction,
    l’intensification, la consolidation, pendant et à la fin de l'entretien
    - Évaluer le taux de réponse global, la date de réponse, la survie sans
    progression, la survie globale, le temps jusqu'à progression et la durée
    de la réponse.
    - Évaluer la faisabilité et la qualité de la collecte de cellules souches
    périphériques.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 years and ≤ 65 years at the time of signing informed consent form
    -Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group Diagnostic Criteria for plasma cells disorders (Leukemia 2009)
    -Subjects must have symptomatic myeloma with CRAB criteria
    -Subjects must have measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l, urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
    -Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject
    -Life expectancy ≥ 3 months
    -ECOG performance status 0–2
    - Un âge ≥ 18 ans et ≤ 65 ans au moment de la signature du formulaire
    de consentement éclairé
    - Un diagnostic de Myélome Multiple selon les Critères diagnostiques
    du Groupe de travail
    - Un Myélome Multiple symptomatique de novo avec atteinte
    organique liée au Myélome ou critères CRAB
    - Une maladie mesurable nécessitant un traitement systémique définie
    par un composant monoclonal sérique ≥ 5 g / l, ou un composant
    monoclonal urinaire ≥ 200 mg/24 h ou des chaines légères libres
    sériques ≥ 100 mg / l.
    - Les sujets ne doivent pas déjà avoir été traités avec un traitement
    systémique pour le myélome multiple. Un traitement antérieur avec des
    corticostéroïdes ou de la radiothérapie ne disqualifie pas le sujet.
    - Une espérance de vie ≥ 3 mois -
    - Un indice de performance ECOG 0-2
    E.4Principal exclusion criteria
    -Pregnant or lactating females
    -Evidence of mucosal or internal bleeding and/or platelet refractory
    -Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment
    -Known human immunodeficiency virus infection
    -Active hepatitis viral infection and history of hepatitis B or C
    -Prior myeloma systemic therapy
    - Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks.
    - Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy.
    - Subjects not eligible for high dose therapy
    - Les femmes enceintes ou qui allaitent
    - un syndrome hémorragique cutanéo-muqueux ou interne et/ou état
    réfractaire aux transfusions plaquettaires
    - une infection aigüe active nécessitant un traitement (antibiotiques,
    antiviraux systémiques, ou antifongiques) dans les 14 jours précédant
    l'inclusion
    - Une infection connue par le virus d'immunodéficience humaine
    - Une hépatite virale active et des antécédents d'hépatite B ou C
    - Un traitement systémique antérieur du myélome
    - Un traitement par radiothérapie localisée si l’intervalle entre la fin de
    la radiothérapie et le début du traitement est de moins de 2 semaines
    -Un traitement par corticostéroïdes de plus de 160 mg d’équivalent
    dexaméthasone dans les 2 semaines
    - Une contre indication à l’intensification thérapeutique
    E.5 End points
    E.5.1Primary end point(s)
    sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation.
    Taux de réponse complète stricte à la fin de la phase de consolidation
    E.5.1.1Timepoint(s) of evaluation of this end point
    sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation..
    Fin de la phase de consolidation
    E.5.2Secondary end point(s)
    -Safety and tolerability of the drug combination in this patient population as induction and consolidation therapy.
    -sCR, CR and VGPR,PR rates after induction, HDM with ASCT, consolidation during and after maintenance
    -Overall response rate, progression free survival, the overall survival, time to progression and duration of response, time to response.
    -Feasibility and quality of the peripheral stem cells collection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-induction and consolidation therapy
    2-consolidation during and after maintenance
    3-NA
    4-Stem cells collection
    1-Induction et consolidation
    2-durant la consolidation et après la maintenance
    3-NA
    4-Collection de cellules souches
    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 Yes
    E.6.4Safety Yes
    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) 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 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 concerned10
    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 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
    60th month.
    the median time survie.Permet meet secondary objectives
    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 months
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state46
    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
    aucun
    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 Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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