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    Summary
    EudraCT Number:2014-005139-14
    Sponsor's Protocol Code Number:54767414SMM2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-14
    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 number2014-005139-14
    A.3Full title of the trial
    A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose
    Schedules in Smoldering Multiple Myeloma
    Uno studio randomizzato di fase 2 per valutare tre programmi di dosaggio di daratumumab nel mieloma multiplo smoldering o asintomatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants with
    Smoldering Multiple Myeloma
    Studio per valutare il trattamento con Daratumumab a 3 dosaggi in pazienti con mieloma multiplo smoldering
    A.3.2Name or abbreviated title of the trial where available
    CENTAURUS
    CENTAURUS
    A.4.1Sponsor's protocol code number54767414SMM2001
    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 NV
    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 CILAG SPA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJanssen Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN-CILAG INTERNATIONAL NV
    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 number0031715242166
    B.5.5Fax number0031715242110
    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.3.9.2Current sponsor codeHuMax-CD38
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeanticorpo monoclonale umano
    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
    Smoldering Multiple Myeloma
    Mieloma multiplo smoldering
    E.1.1.1Medical condition in easily understood language
    Smoldering Multiple Myeloma
    Mieloma multiplo smoldering
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 evaluate if daratumumab can effectively decrease M protein in
    subjects with intermediate or high-risk SMM as assessed by CR rate
    - To determine if daratumumab reduces the progression/death rate in
    subjects with intermediate or high-risk SMM
    ¿ Valutare se daratumumab pu¿ effettivamente diminuire la proteina M in soggetti con MM smoldering (SMM) intermedio o ad alto rischio valutato dal tasso di CR
    ¿ Determinare se daratumumab riduce il tasso di progressione/morte in soggetti con SMM intermedio o ad alto rischio
    E.2.2Secondary objectives of the trial
    - To evaluate preliminary efficacy, including Overall Response Rate
    (ORR) and progressionfree survival (PFS)
    - To evaluate the minimal residual disease (MRD) negative rate
    - To evaluate the pharmacokinetics and immunogenicity of daratumumab
    - To assess the safety profile of daratumumab given in 3 different dosing
    schedules
    - To determine if daratumumab has an effect on QT interval
    ¿ Valutare l'efficacia primaria, incluso il tasso di risposta generale (ORR) e la sopravvivenza libera da progression (PFS)
    ¿ Valutare il tasso negativo di MRD (malattia minima residua)
    ¿ Valutare la farmacocinetica e l'immunogenicit¿ di daratumumab
    ¿ Valutare il profilo di sicurezza di daratumumab somministrato in 3 diversi programmi di dosaggio
    ¿ Determinare se daratumumab ha un effetto sull'intervallo QT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
    - have a confirmed diagnosis of intermediate or high-risk SMM, and an
    Eastern Cooperative Oncology Group (ECOG) performance status score of
    0 or 1
    -diagnosi di SMM da < 5 anni.
    -diagnosi di SMM intermedio o ad alto rischio e punteggio dello stato di validità ECOG pari a 0 o 1
    E.4Principal exclusion criteria
    - Active multiple myeloma, requiring treatment as defined by the study
    protocol
    - Primary systemic AL (immunoglobulin light chain) amyloidosis- Prior or concurrent exposure to any of the following: approved or
    investigational treatments for SMM
    or/and multiple myeloma, daratumumab or other anti CD-38 therapies,
    treatment with corticosteroids with a
    dose greater than (>) 10 milligram (mg) prednisone per day or
    equivalent and bone-protecting agents (eg,
    bisphosphonates, denosumab) or are only allowed if given in a stable
    dose and for a nonmalignant
    condition, or received an investigational drug (including investigational
    vaccines) or used an invasive
    investigational medical device within 4 weeks before Cycle 1, Day 1
    - History of malignancy (other than SMM) within 3 years before the date
    of randomization, except for the following if treated and not active: basal
    cell or nonmetastatic squamous cell carcinoma of the skin, cervical
    carcinoma in situ, ductal carcinoma in situ of breast, or International
    Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of
    the cervix
    - known chronic obstructive pulmonary disease (COPD) OR moderate or
    severe persistent asthma within the past 2 years
    - any concurrent medical or psychiatric condition or disease (eg,
    autoimmune disease, active systemic disease, myelodysplasia) that is
    likely to interfere with the study procedures or results, or that in the
    opinion of the investigator, would constitute a hazard for participating in
    this study
    MM attivo che richieda un trattamento, definito nel protocollo
    Amiloidosi sistemica primaria AL (catena leggera dell'immunoglobulina)
    Esposizione precedente o concomitante a uno qualsiasi dei seguenti elementi: trattamenti approvati o sperimentali per SMM e/o MM, Daratumumab o altre terapie anti CD-38, trattamento con corticosteroidi con dose maggiore di (>) di 10 mg di prednisone al giorno o equivalente e agenti di protezione ossea (ad es. bifosfonati, denosumab) sono consentiti solo se somministrati in dosaggio stabile e per una condizione non maligna, assunzione di un farmaco sperimentale (inclusi i vaccini sperimentali) o utilizzo di un dispositivo medico sperimentale invasivo nelle 4 settimane precedenti al Ciclo 1 Giorno 1.
    Storia di tumore maligno (diverso da SMM) nei 3 anni precedenti alla data di randomizzazione, eccetto per i seguenti se trattati e non attivi: carcinoma della pelle a cellule squamose non metastatico o a cellule basali, carcinoma cervicale in situ, carcinoma duttale in situ dela mammella o carcinoma della cervice di stadio 1 secondo l'International Federation of Gynecology and Obstetrics (FIGO).
    Malattia polmonare ostruttiva cronica (COPD)
    Asma persistente moderata o grave negli ultimi due anni
    Ogni condizione o patologia medica o psichiatrica concomitante (ad es. malattia autoimmune, malattia sistemica attiva, mielodisplasia) che può interferire con le procedure o i risultati dello studio o che, secondo lo sperimentatore, potrebbe costituire un rischio per la partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    1. The percentage of participants who achieve a complete response (CR)
    2. The percentage of participants that have an event (disease
    progression or death) per patient-year
    1. Percentuale dei pazienti che raggiungono la risposta complerta (CR)
    2. Percentuale dei pazienti che hanno un evento(morte o progressione di malattia) per paziente/anno
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 24 months for point 1.
    Up to approximately 30 months for point 2.
    Fino a circa 24 mesi per il punto 1
    Fino a circa 30 mesi per il punto 2
    E.5.2Secondary end point(s)
    1. The percentage of participants who are minimal residual disease (MRD) negative.
    2. Time to next treatment (TNT).
    3. The percentage of participants who achieve a Complete Response (CR)
    or a Partial Response (PR)
    4. The median time of progression free survival (PFS)
    5. The percentage of participants with symptomatic multiple myeloma
    6. Response to first subsequent multiple myeloma treatment
    7. Overall survival rate
    ¿Tasso negativo di malattia minima residua
    ¿Tempo al trattamento successivo
    ¿Tasso di risposta generale definito come tasso CR+PR
    ¿PFS, definita come il tempo dalla data della randomizzazione alla data della PD documentata iniziale in base ai criteri CRAB o alla data del decesso, a seconda dell'evento che si verifica prima. Per i soggetti che sono liberi da progressione e sono in vita al momento del cut-off dei dati per un'analisi, la PFS sar¿ limitata alle loro ultime valutazioni della malattia o prima dell'inizio della successiva terapia anti-MM, alla perdita del follow-up, o al ritiro del consenso qualora uno di questi eventi si presenti, oppure alle ultime valutazioni della malattia se nessuno di questi eventi si presenta. La PFS sar¿ limitata alla data della randomizzazione se non vi ¿ alcuna valutazione della malattia registrata postbaseline.
    ¿ Incidenza di MM sintomatico con caratteristiche prognostiche avverse, che comprendono lo stadio III dell'International Staging System (ISS) (sulla base di ¿2-microglobulina e albumina) e caratteristiche citogenetiche avverse
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5.5 years
    Fino a 5.5 anni
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 trial3
    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 EEA26
    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 Information not present in EudraCT
    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
    Canada
    Czechia
    France
    Germany
    Israel
    Italy
    Netherlands
    Russian Federation
    Turkey
    United Kingdom
    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 end of the study will occur approximately 4 years after the last
    participant is enrolled and receives a first dose of study drug. Refer to
    protocol.
    La fine dello studio avverr¿ 4 anni dopo l'arruolamento dell'ultimo paziente e dell'assunzione della prima dose di trattamento. Si faccia riferimento al protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 120
    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)
    After the end of the study, the sponsor will ensure that subjects
    benefiting from treatment with daratumumab will be able to continue
    treatment.
    Al termine dello studio lo sponsor assicurer¿ ai pazienti che hanno beneficiato del trattamento con Daratumumab il proseguimento del trattamento
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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