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    Summary
    EudraCT Number:2018-004330-15
    Sponsor's Protocol Code Number:D20180138
    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:2018-12-07
    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 number2018-004330-15
    A.3Full title of the trial
    A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma
    Étude de phase III randomisée, multicentrique, comparant l’administration continue ou pour une durée fixe de l’association daratumumab, lenalidomide et dexaméthasone dans le myélome multiple en rechute
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma
    Étude de phase III randomisée, multicentrique, comparant l’administration continue ou pour une durée fixe de l’association daratumumab, lenalidomide et dexaméthasone dans le myélome multiple en rechute
    A.3.2Name or abbreviated title of the trial where available
    CONFIRM
    CONFIRM
    A.4.1Sponsor's protocol code numberD20180138
    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 SponsorAssistance Publique - Hôpitaux 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 supportInca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpîtal Saint-Louis
    B.5.3 Address:
    B.5.3.1Street AddressDRCI Hôpital St Louis, 1 av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841780
    B.5.5Fax number33144841701
    B.5.6E-mailmaud.jacubert@aphp.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 DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    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 numberEU/1/16/1101
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.4Pharmaceutical form 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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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 REVLIMID
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE
    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 nameLenalidomide
    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 typerange
    D.3.10.3Concentration number5 to 25
    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.2.1.2Country 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 nameDexamethasone
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    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
    myeloma
    myelome
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10051381
    E.1.2Term Myeloma recurrence
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The present randomized trial is primarily designed to show the non-inferiority in overall survival at 4 years of the Dara-Len-Dex combination for treatment of MM at first relapse administered for a fixed duration of 24 months (experimental arm) versus continuous administration (control arm) until disease progression
    Cet essai randomisé est principalement conçu pour montrer la non-infériorité sur la survie globale à 4 ans de l'association Dara-Len-Dex pour le traitement du MM en première rechute, administrée pendant une durée fixe de 24 mois (bras expérimental) versus administration continue (bras témoin) jusqu'à progression de la maladie
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    • To compare:
    - the response rate after salvage therapy and achievement of a minimal residual disease
    - the overall response rate following salvage therapy
    - progression-free survival (PFS)
    - Serious adverse events
    • To compare the impact of the treatment strategies on Quality of Life (QoL).
    • To perform a cost-effectiveness analysis
    • To perform a budget impact analysis
    Objectifs secondaires :
    • Comparer :
    - le taux de réponse après le traitement de rattrapage et le taux d'obtention de maladie résiduelle minime négative (MRD)
    - le taux de réponse global après traitement de rattrapage
    - la survie sans progression (SSP)
    - les événements indésirables graves
    • Comparer l'impact des stratégies de traitement sur la Qualité de Vie (QdV).
    • Effectuer une analyse coût-efficacité
    • Effectuer une analyse d'impact budgétaire
    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 assess durability of MRD negativity
    Evaluer la durabilité de la négativité de la MRD
    E.3Principal inclusion criteria
    1/ Adult patients (≥ 18 years old)
    2/ Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
    3/ Subject must have received one prior line of therapy for MM.
    4/ Subject must have achieved a response (PR or better) to the prior regimen.
    5/ Subject must have an ECOG Performance Status score of 0, 1, or 2.
    6/ For subjects experiencing serious toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
    7/ Signed informed consent
    8/ Affiliation to a social security system or equivalent (recipient or assign)
    9/ Effective method of contraception for the duration of treatment and 3 months after the last dose for women and men with a partner of childbearing age:
    • Progestin-only pill associated with inhibition of ovulation
    • Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs)
    • non-hormonal IUD
    • Bilateral tubal occlusion
    • Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success
    • Intrauterine hormone release system (IUS)
    • Complete Abstinence: Complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
    1/ Patient adulte (≥ 18 ans)
    2/ MM en rechute (documenté) selon des critères standards IMWG et nécessitant l'initiation d'une première thérapie de rattrapage.
    3/ Le sujet doit avoir reçu une ligne de traitement antérieure pour MM.
    4/ Le sujet doit avoir obtenu une réponse (PR ou mieux) à la ligne de traitement antérieure.
    5/ Le sujet doit avoir un score d'état de performance ECOG de 0, 1 ou 2.
    6/ Pour les sujets présentant des toxicités résultant d'un traitement antérieur (y compris la neuropathie périphérique), les toxicités doivent avoir été résolues ou stabilisées.
    7/ Consentement éclairé signé
    8/ Affiliation à un système de sécurité sociale ou équivalent (destinataire ou assignateur)
    9/ Méthode de contraception efficace pendant toute la durée du traitement et 3 mois après la dernière prise pour les femmes et les hommes ayant une partenaire en âge de procréer :
    • Pilule progestative associée à l’inhibition de l’ovulation
    • Méthodes hormonales de contraception, y compris les pilules contraceptives orales contenant une combinaison d'┼ôstrogène + progestérone, anneau vaginal, injectables, implants et Dispositifs intra-utérins (DIU)
    • DIU non hormonal
    • Occlusion tubaire bilatérale
    • Homme vasectomisé avec une azoospermie documentée 90 jours après la procédure et qui a reçu une évaluation médicale du succès chirurgical
    • Système de libération d'hormones intra-utérines (IUS)
    • Abstinence complète : abstinence complète est définie comme l'évitement complet de rapports hétérosexuels, forme de contraception acceptable pour tous les médicaments d'étude et doit être utilisé pendant toute la durée de l'étude et pour la durée du temps spécifié ci-dessus. Il n'est pas nécessaire d'utiliser une autre méthode de contraception lorsque l'abstinence est complète. Des méthodes alternatives acceptables de contraception hautement efficaces doivent être discutées dans le cas où le sujet choisit de renoncer à l'abstinence complète
    E.4Principal exclusion criteria
    1/ Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) -containing regimen, the subject is excluded if he or she:
    • Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or
    • If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab is defined either as:
    o Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or
    o Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody).
    2/ Subject has received an allogenic stem cell transplant (regardless of timing).
    3/ Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant.
    4/ Subject has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).
    5/ Subject has known MM meningeal involvement.
    6/ Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
    7/ Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the investigator would constitute a hazard for participating in this study.
    8/ Subject has known uncontrolled chronic obstructive pulmonary disease (COPD)
    9/ Subject has clinically significant cardiac disease.
    10/ Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
    11/ Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min).
    12/ Hypersensitivity to the active substance or to any of the excipients
    1/ Patient réfractaire ou preuve d'intolérance au lénalidomide et/ou au daratumumab (ou autre anticorps monoclonal anti-CD38). S'il a déjà été traité avec une ligne de traitement contenant du lénalidomide ou du daratumumab (ou autre anticorps monoclonal anti-CD38), le sujet est exclu si :
    • l’interruption du traitement est due à un événement indésirable grave lié au traitement antérieur par le lénalidomide et/ou le daratumumab (ou autre anticorps monoclonal anti-CD38), ou
    • si, à tout moment, le sujet était réfractaire à toute dose de lénalidomide et/ou de daratumumab (ou autre anticorps monoclonal anti-CD38). Est considéré réfractaire au lénalidomide et/ou au daratumumab (ou autre anticorps monoclonal anti-CD38):
    o sujets dont la maladie a progressé dans les 60 jours suivant l'administration de lénalidomide et/ou de daratumumab (ou autre anticorps monoclonal anti-CD38); ou
    o sujets dont la maladie ne répond pas pendant le traitement par le lénalidomide et/ ou le daratumumab. Une maladie non réactive est définie comme l'incapacité à obtenir au moins une réponse minimale ou la progression de la maladie pendant le traitement par le lénalidomide et/ou le daratumumab (ou autre anticorps monoclonal anti-CD38).
    2/ Sujet ayant reçu une allogreffe de cellules souches hématopoïétiques (indépendamment du moment).
    3/ Sujets éligibles pour subir une greffe de cellules souches avant la progression de la maladie dans le cadre de cette étude, c'est-à-dire que ces sujets ne devraient pas être inscrits afin de réduire le fardeau de la maladie avant la transplantation.
    4/ Sujet avec des antécédents de malignité (autres que MM) dans les 3 ans précédant la date de randomisation (sauf les carcinomes épidermoïdes et basocellulaires de la peau, les carcinomes in situ du col de l'utérus ou les tumeurs malignes qui, de l'avis de l'investigateur guéri avec un risque minimal de récidive dans les 3 ans).
    5/ Sujet ayant eu une atteinte méningée MM.
    6/ Sujet avec une leucémie plasmocytaire (> 2,0 × 109/L de plasmocytes circulants par différentiel standard) ou macroglobulinémie de Waldenström ou syndrome POEMS (polyneuropathie, organomégalie, endocrinopathie, protéines monoclonales, altérations cutanées) ou amyloïdose.
    7/ Sujet souffrant d'un trouble médical ou d'une maladie concomitante (ex. infection systémique active) susceptible d'interférer avec les procédures ou les résultats de l'étude ou qui, de l'avis de l'investigateur, constituerait un danger pour la participation à cette étude.
    8/ Sujet avec une maladie pulmonaire obstructive chronique (MPOC) non contrôlée
    9/ Sujet a une maladie cardiaque cliniquement significative.
    10/ Sujet avec statut séropositif pour le virus de l'immunodéficience humaine (VIH), l'hépatite B ou l'hépatite C connu.
    11/ Clairance de la créatinine ≤ 30 mL/min (méthode MDRD) (ajustement de la dose de lénalidomide sera envisagé pour les sujets ayant une clairance de la créatinine comprise entre 30 et 60 mL/min).
    12/ Hypersensibilité à la substance active ou à l’un des excipients
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) at 4 years after randomization and initiation of salvage therapy
    Survie globale à 4 ans après randomisation et initiation du traitement de rattrapage
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 years
    4 ans
    E.5.2Secondary end point(s)
    • Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20:1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff.
    • Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy.
    • PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization.
    • Incidence of adverse events within the 4 years after randomization.
    • QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels).
    • The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in cost per Life Year Gained, and in cost per progression free year gained.
    • The budget impact analysis based upon target and prevalent populations’ estimations.
    • Taux de réponse selon les critères IMWG (Durie BG, et al. Leukemia. 2006;20:1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), pendant ou après le traitement de l'étude au moment de l’analyse des données.
    • Taux de réponse global, défini comme la proportion de sujets qui atteignent CR ou PR selon les critères IMWG, suite à une thérapie de rattrapage.
    • PFS qui est définie comme la durée depuis la date de la randomisation jusqu’à progression de la maladie (selon les critères IMWG) ou décès, à 4 ans après la randomisation.
    • Incidence des événements indésirables dans les 4 années suivant la randomisation.
    • QdV sera évaluée après la randomisation toutes les 12 semaines jusqu'à la progression de la maladie, puis au dernier suivi sur la base du questionnaire EORTC QLQ-C30 (Questionnaire sur la qualité de vie du noyau de l'Organisation européenne pour la recherche et le traitement du cancer - Core 30) et du questionnaire EQ-5D 5L (EuroQol - cinq dimensions - cinq niveaux).
    • Les rapports coûts-efficacité incrémentaux (ICERs) exprimés en coût par année de vie pondérée par la qualité (QALY) gagnée, en coût par année de vie gagnée, et en coût par année sans progression gagnée.
    • Analyse d'impact budgétaire basée sur les estimations des populations cibles et la prévalence.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 years
    4 years
    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 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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    association Dara-Len-Dex pendant une durée fixe vs traitement jusqu'à progression de la maladie
    fixed duration of Dara-Len-Dex combination vs treatment until disease progression
    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 concerned48
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 284
    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 No
    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 state434
    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 Decision2018-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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