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    Summary
    EudraCT Number:2014-000255-85
    Sponsor's Protocol Code Number:54767414MMY3004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000255-85
    A.3Full title of the trial
    Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
    Studio di fase 3 sul confronto fra daratumumab, bortezomib e desametasone (DVd) verso bortezomib e desametasone (Vd) in soggetti con mieloma multiplo recidivante o refrattario.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) with Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma
    Studio che confronta daratumumab, bortezomib e desametasone (DVd) verso bortezomib e desametasone (Vd) in soggetti con mieloma multiplo recidivante o refrattario.

    A.4.1Sponsor's protocol code number54767414MMY3004
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 715242166
    B.5.5Fax number+31 715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 No
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code HuMax-CD38
    D.3.4Pharmaceutical form Concentrate 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 INNDaratumumab
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB29447
    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.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
    Mieloma multiplo
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Mieloma multiplo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of daratumumab when combined with VELCADE and dexamethasone (DVd) to that of VELCADE and dexamethasone (Vd), in terms of progression-free survival (PFS) in subjects with relapsed or refractory multiple myeloma.
    Consiste nel confrontare l'efficacia di daratumumab in combinazione con VELCADE (bortezomib) e desametasone (DVd) rispetto a quella di VELCADE e desametasone (Vd), in termini di sopravvivenza senza progressione (PFS), in soggetti con mieloma multiplo recidivante o refrattario.
    E.2.2Secondary objectives of the trial
    The major secondary objectives are as follows:
    - To evaluate clinical outcomes including time to disease progression (TTP), overall response rate (ORR), and overall survival (OS).
    - To evaluate the proportion of subjects with a response of very good partial response (VGPR) or better.
    - To evaluate duration of and time to response.
    - To assess the safety and tolerability of daratumumab when administered in combination with Vd.
    - To assess Minimal Residual Disease (MRD) in subjects who achieve ≥VGPR.
    - To assess the pharmacokinetics of daratumumab in combination with Vd.
    - To assess the immunogenicity of daratumumab.
    - To evaluate treatment effects on patient reported outcomes (PROs) including the EuroQol-5 Dimensions (EQ-5D-5L) and EORTC QLQ-C30.
    - To evaluate clinical efficacy of DVd in high risk molecular subgroups (del17p, t(4;14), t(14;20), UAMS-70).
    Gli obiettivi secondri principali sono:
    •Valutare i risultati clinici tra cui tempo prima della progressione della malattia (TTP), tasso di risposta generale (ORR) e sopravvivenza globale (OS).
    •Valutare la proporzione dei soggetti con risposta parziale molto buona (VGPR) o migliore.
    •Valutare la durata della risposta e il tempo trascorso prima della risposta.
    •Determinare la sicurezza e la tollerabilità di daratumumab somministrato in combinazione con Vd.
    •Valutare la malattia residua minima (MRD) in soggetti che raggiungono >VGPR.
    •Valutare la farmacocinetica di daratumumab in combinazione con Vd.
    • Valutare l'immunogenicità di daratumumab.
    •Valutare gli effetti del trattamento sugli esiti riferiti dai pazienti (PRO) tra cui dimensioni EuroQol-5 (EQ-5D-5L) e EORTC QLQ-C30.
    •Valutare l'efficacia clinica di DVd nei sottogruppi molecolari a rischio elevato (del17p, t(4;14), t(14;20),UAMS-70).

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must have documented multiple myeloma
    - Must have received at least 1 prior line of therapy for multiple myeloma
    - Must have documented evidence of progressive disease as defined by the
    International Myeloma Working Group criteria on or after their last regimen
    - Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
    - Must have achieved a response (partial response or better) to at least 1 prior regimen
    -Presentare un mieloma multiplo documentato
    -Aver ricevuto almeno una precedente linea terapeutica per il mieloma multiplo
    -Mostrare una evidenza documentata di progressione di malattia definita in base ai criteri IMWG durante o dopo l'ultimo regime
    -Presentare un punteggio dello stato di performance ECOG pari a 0, 1 o 2
    -Avere raggiunto una risposta (risposta parziale o migliore) almeno ad un precedente regime
    E.4Principal exclusion criteria
    - Has received daratumumab or other anti-CD38 therapies previously
    - Is refractory to VELCADE (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy
    - Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
    - Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization
    - Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
    - Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures
    -Il soggetto ha ricevuto precedenti terapie con daratumumab o altre terapie anti-CD38.
    -Il soggetto è refrattario a VELCADE (cioè il soggetto ha manifestato una progressione della malattia durante la terapia con VELCADE o entro 60 giorni dal termine della terapia con VELCADE).
    -Il soggetto è intollerante a VELCADE (cioè ne ha interrotto l'assunzione a causa di eventi avversi manifestatisi durante il trattamento con
    VELCADE).
    -Il soggetto ha ricevuto un trattamento anti-mieloma entro 2 settimane o 5 emivite farmacocinetiche dal trattamento, a seconda del periodo più lungo, prima della data della randomizzazione.
    -Il soggetto ha una storia di tumore maligno (diverso dal mieloma multiplo) sviluppato nei 3 anni precedenti la data di randomizzazione 8. Il soggetto presenta un coinvolgimento meningeo noto del mieloma multiplo.
    -Il soggetto presenta una condizione o patologia medica concomitante (ad es., infezione sistemica attiva) che può interferire con le procedure
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants with progression-free survival (PFS)
    Percentuale di partecipanti senza progressione di malattia (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, up to the end of the study
    Dalla visita di baseline fino alla fine dello studio
    E.5.2Secondary end point(s)
    1. Time to disease progression (TTP)
    2. Percentage of Participants With Overall Response
    3. Duration of response
    4. Time to Response
    5. Percentage of participants with a very good partial response (VGPR) or better
    6. Percentage of participants with Minimal Residual Disease (MRD)
    7. Percentage of participants with overall survival (OS)
    1. Tempo alla progressione di malattia (TTP)
    2. Percentuale di partecipanti con risposta
    3. Durata della risposta
    4. Tempo alla risposta
    5. Percentuale di partecipanti con una risposta veramente buona (VGPR) o migliore
    6. Percentuale di partecipanti con malattia minima residua (MRD)
    7. Percentuale di partecipanti in sopravvivenza (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For all secondary end points except 4 is Baseline, up to the end of the study
    - for secondary end point 4 is Baseline until first documented response
    -Per tutti gli end-points secondari eccetto il nr. 4 è dalla visita di baseline fino alla fine dello studio
    -Per end-point secondario nr. 4 è dalla visita di baseline fino alla prima risposta documentata
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Czech Republic
    Germany
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Turkey
    Ukraine
    United States
    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
    the following is included in the protocol : The study is considered completed after 320 deaths have occurred.
    definizione in protocollo: lo studio è considerato completo al raggiungimento di 320 decessi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days27
    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: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 288
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 480
    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)
    Daratumumab will be provided to patients who are benefiting from the drug at the end of study .
    Daratumumab sarà fornito dopo la fine dello studio ai pazienti che traggono beneficio
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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