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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   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:2014-000634-34
    Sponsor's Protocol Code Number:13704501
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-000634-34
    A.3Full title of the trial
    IFM 2014-02 study: A randomized phase III study of Bortezomib-Melphalan 200 conditioning regimen versus Melphalan 200 for frontline transplant eligible patients with multiple myeloma
    Etude IFM 2014-02:
    Intérêt d’un conditionnement par bortezomib-melphalan 200 vs melphalan 200 suivi d’une autogreffe de cellules souches chez les patients de moins de 66 ans atteints de myélome multiple en première ligne: une étude randomisée de phase III de l’IFM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Bortezomib-Melphalan 200 conditioning regimen versus Melphalan 200 for frontline transplant eligible patients with multiple myeloma
    Intérêt d’un conditionnement par bortezomib-melphalan 200 versus melphalan 200 suivi d’une autogreffe de cellules souches chez les patients de moins de 66 ans atteints de myélome multiple traités pour la première fois
    A.3.2Name or abbreviated title of the trial where available
    Etude IFM 2014-02
    A.4.1Sponsor's protocol code number13704501
    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 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 supportDGOS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportJANSSEN PHARMACEUTICA NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Toulouse
    B.5.2Functional name of contact pointBOGDANOVITCH.L@chu-toulouse.fr
    B.5.3 Address:
    B.5.3.1Street Address2 rue viguerie
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31000
    B.5.3.4CountryFrance
    B.5.4Telephone number33561778437
    B.5.5Fax number33561778411
    B.5.6E-mailBOGDANOVITCH.L@chu-toulouse.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 Bortezomib (Velcade)
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL
    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 numberORPHA58381
    D.3 Description of the IMP
    D.3.1Product nameBortezomib
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 RoleComparator
    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 Melphalan (Alkéran)
    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 Powder and solvent for solution for infusion
    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 INNMELPHALAN
    D.3.9.1CAS number 148-82-3
    D.3.9.4EV Substance CodeSUB08728MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Myeloma
    Myelome
    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
    To compare the Complete Response rates (according to IMWG 2011 criteria) 60 days post ASCT conditioned with bortezomib-melphalan versus melphalan alone (before consolidation therapy).
    Comparer les taux de réponse complète (selon les critères de l’IMWG 2011), 60 jours après autogreffe de cellules souches périphériques conditionnée par bortezomib-melphalan vs melphalan seul (avant le traitement de consolidation)
    E.2.2Secondary objectives of the trial
    To compare response rates after ASCT and after the completion of consolidation therapy between the two arms
    To compare the safety profile of bortezomib-melphalan versus melphalan alone
    To compare progression-free survival between the two arms
    To compare overall survival between the two arms.
    - Comparer les taux de réponse après autogreffe et après consolidation entre les deux bras
    - Comparer la toxicité de ce conditionnement par bortezomib-melphalan vs melphalan seul
    - Comparer la survie sans progression entre les deux bras
    - Comparer la survie globale entre les deux bras
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To identify clinical and biological prognostic factors predicting response rates
    Identifier les facteurs pronostiques cliniques et biologiques prédisant les taux de réponses.
    E.3Principal inclusion criteria
    - Age ≥ 18 years and ≤ 65 years at the time of induction therapy start
    - Must have results from their initial multiple myeloma diagnosis available at the time of screening to confirm all the following :
    1- Diagnosis of multiple myeloma according to the diagnostic criteria of the International Working Group plasma cell dyscrasias (Leukemia 2009)
    2- Symptomatic de novo Multiple Myeloma with myeloma-related organ damage according to the CRAB criteria
    3-Measurable disease requiring systemic treatment defined by a serum monoclonal protein ≥ 5 g / l, urinary monoclonal protein ≥ 200 mg/24 h or serum free light chains ≥ 100 mg / l
    Must have had induction chemotherapy (at the discretion of clinical physician but preferably by 4 cycles of VTD or VCD) with a maximum of 5 cycles. Induction performed with combined induction therapy (e.g use of VTD followed by VRD) will not be authorized if induction treatment switch is due to patient non-response or disease progression.
    - Be eligible for high-dose therapy with autologous stem cell transplantation.
    - Autologous cell graft with a total number of CD 34 cells ≥ 5 X 106/kg before freezing. A minimum of 2 x 106 CD34/kg is required
    - LVEF > 40 %
    - DLCO >50 %.
    - ECOG performance status ≤2
    - ALT ≤ 3.5 times upper limit of normal and total bilirubin ≤ 1,5 times institutional upper limit of normal (ULN) (Patients with benign hyper bilirubinemia e.g., Gilbert’s syndrome, are eligible )
    - eGFR ≥ 40 mL / minute; MDRD formula should be used to calculate the creatinine clearance: http://mdrd.com/. Renal function must be verified within 7 days from treatment start.
    - Voluntary written informed consent
    - Women of childbearing potential must have a negative pregnancy test (serum or urine) before treatment start. They should take effective and acceptable method of contraception before treatment start, during treatment phase and up to 4 weeks after the last treatment administration. Women must also agree to perform iterative pregnancy tests during treatment.
    - Men must agree not to conceive a child and agree to use a latex condom during the duration of treatment and for 4 weeks after the last treatment administration, even if they have undergone a successful vasectomy if their partner is of childbearing potential.
    - Participants with social security insurance or equivalent social protection.
    - Un âge ≥ 18 ans et ≤ 65 ans au moment du démarrage du traitement d'induction
    - Doivent présenter les résultats de leur bilan de diagnostic initial de myélome multiple pour pouvoir confirmer les informations suivantes :
    1- Un diagnostic de Myélome Multiple selon les Critères diagnostiques du Groupe de travail international des dyscrasies plasmocytaires (Leukemia 2009)
    2- Un myélome multiple symptomatique de novo avec atteinte organique liée au myélome selon les critères CRAB décrits dans le protocole
    3- un taux de protéine sérique monoclonale ≥ 5g/L, un taux de protéine urinaire monoclonale ≥ 200mg/24h ou un taux de chaînes légères sériques ≥ 100mg/L
    Doit avoir eu une chimiothérapie d'induction (à la discrétion du physicien clinique mais préférablement par 4 cycles de VTD ou VCD) avec un maximum de 5 cycles. Induction réalisée avec un traitement d'induction combiné (ex. : utilisation de VTD suivi de VRD) ne sera pas autorisé si le changement du traitement d'induction est dû à une non réponse du patient ou à la progression de la maladie.
    - Etre éligible pour un traitement à haute dose avec autogreffe de cellules souches
    - Greffon avec un nombre de CD 34 ≥ à 5 x 106/Kg sur l'ensemble des collectes avant congélation. Un minimum de 2 x 106/Kg est nécessaire.
    - FEVG> 40 %
    - DLCO>50 %
    - ECOG ≤ 2
    - ALAT ≤ 3,5 fois la limite supérieure de la normale et bilirubine totale normale ≤ 1,5 fois la limite supérieure institutionnelle des normes (Patients avec bilirubinémie hyper bénigne, ex. syndrome de Gilbert, sont éligibles)
    - DFG ≥ 40 mL/min. Formule MDRD à utiliser pour calculer la creatinine clearance: http://mdrd.com/. Fonction rénale doit être vérifiée dans les 7 jours du démarrage du traitement
    - Le consentement volontaire et éclairé écrit
    - Les femmes en âge de procréer doivent avoir un test de grossesse sérique ou urinaire négatif avant de commencer le traitement à l'étude. Elles doivent prendre une méthode de contraception efficace et acceptable avant de démarrer le traitement, pendant toute la durée du traitement et jusque 4 semaines après la dernière prise de traitement. Les femmes doivent également consentir à réaliser des tests de grossesse itératifs en cours de traitement.
    - Les hommes doivent accepter, si leur partenaire est susceptible de procréer, de ne pas concevoir un enfant et accepter d'utiliser un préservatif en latex pendant toute la durée du traitement et pendant 4 semaines après la dernière dose de médicament à l'étude, même s'ils ont subi une vasectomie réussie.
    - Les patients doivent être assurés sociaux ou bénéficier d’une protection sociale équivalente
    E.4Principal exclusion criteria
    - Progressive disease
    - Females participants pregnant or breast-feeding
    - A known infection by the human immunodeficiency virus
    - An active viral hepatitis B or C
    - Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
    - Uncontrolled hypertension or uncontrolled diabetes
    - A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator.
    - A significant neuropathy of grade 3-4 or grade 2 with pain
    - Known allergy to any of the study drugs, their analogs, or their excipients in their various formulations
    - Known allergy to corticosteroids
    - A contraindication to one drug or a required concomitant medication, including hypersensitivity to all anticoagulation and / or antiplatelet drugs, antiviral drugs
    - Any other clinically significant disease that, in the opinion of the investigator, may interfere with adherence to the protocol or the patient's ability to give informed consent.
    -Participant under juridical protection.
    - Les patients avec une maladie en progression
    - Les femmes enceintes ou qui allaitent
    - Une infection connue par VIH
    - Une hépatite virale B ou C active
    - Un angor instable ou un infarctus du myocarde dans les 4 mois précédant l'inclusion, une insuffisance cardiaque de classe NYHA III ou IV, une angine de poitrine non contrôlée, des antécédents de maladie coronarienne grave, une arythmie ventriculaire grave non contrôlée, une maladie du nœud sinusal, ou des signes électrocardiographiques d'ischémie aiguë ou de troubles de conduction de grade 3 sauf si le patient a un stimulateur cardiaque
    - Une hypertension non contrôlée ou un diabète non contrôlé
    - Des antécédents d’une autre pathologie maligne. Si un cancer a été diagnostiqué il y a plus de 10 ans et est déclaré comme guéri, une autorisation pourra être demandée au cas par cas après discussion avec l’investigateur principal.
    - Une neuropathie significative de grade 3-4 ou grade 2 avec douleurs
    - Des antécédents d'allergie à l'un des médicaments de l'étude, leurs analogues, ou leurs excipients dans leurs différentes formes
    - Une intolérance connue aux corticostéroïdes
    - Une contre-indication à l'un des médicaments ou à l’un des traitements concomitants nécessaires, y compris une hypersensibilité à tous les anticoagulants et/ou antiplaquettaires, aux médicaments antiviraux
    - Toute autre maladie cliniquement significative qui, de l'avis de l'investigateur, peut interférer avec l'observance au protocole ou avec la capacité du patient à donner un consentement éclairé.
    - Le patient sous protection juridique
    E.5 End points
    E.5.1Primary end point(s)
    Complete Response rates at day 60 (a window of +15 days is allowed) post PBSC infusion according to IMWG 2011 response criteria. Responses will be reviewed by an experienced reviewer blinded to the treatment assignment.
    Taux de réponse complète 60 jours (+/- 30) après autogreffe selon les critères IMWG 2011. Les réponses seront revues en aveugle pour la désignation du traitement par un comité d'experts.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 60 (a window of +15 days is allowed) post PBSC infusion
    60 jours (+/- 15) après autogreffe
    E.5.2Secondary end point(s)
    - Response rates (sCR, CR, VGPR, PR, SD) at day 60 post PBSC infusion and at the completion of consolidation according to IMWG 2011 criteria (with responses review process).
    Toxicities according to NCI CTCAE v4.
    Progression-free survival (PFS) and overall survival (OS).
    PFS is defined as the time from randomization to the disease progression or death for any cause.
    - Taux de réponses (sRC, RC, TBRP, RP, MS) après autogreffe et en fin de consolidation
    -Toxicité
    -Survie sans progression et survie globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    -1: post PBSC infusion and at the completion of consolidation
    -2: throughout the duration of treatment for patients and up to 60 days after the last dose of study treatment
    -3: NA
    - 1: 60 jours (+/- 15) après autogreffe et à la fin de la consolidation
    - 2:Toxicité: durant toute la durée du traitement des patients et jusqu'à 60 jours après la dernière prise du traitement à l'étude
    - 3: NA
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Melphalan
    E.8.2.4Number of treatment arms in the trial2
    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 EEA48
    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
    48th 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 months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2015-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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