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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-017237-22
    Sponsor's Protocol Code Number:CNTO328MMY3001
    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:2011-09-19
    Trial results View 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 number2009-017237-22
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma
    Uno studio di fase III, randomizzato, in doppio cieco sulla somministrazione di siltuximab (anticorpo monoclonale anti-IL-6) o placebo in associazione a VELCADE e desametasone per il trattamento di soggetti con mieloma multiplo recidivante o refrattario
    A.4.1Sponsor's protocol code numberCNTO328MMY3001
    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 BIOLOGICS B.V.
    B.1.3.4CountryNetherlands
    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 supportCENTOCOR BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG SPA
    B.5.2Functional name of contact pointGCO
    B.5.3 Address:
    B.5.3.1Street AddressVIA BUONARROTI 23
    B.5.3.2Town/ cityCOLOGNO MONZESE
    B.5.3.3Post code20093
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 2510 569
    B.5.5Fax number+39 02 2510537
    B.5.6E-mailscazzani@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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSILTUXIMAB
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder 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 INNSILTUXIMAB
    D.3.9.2Current sponsor codeCNTO328
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    RELAPSED OR REFRACTORY MULTIPLE MYELOMA
    MIELOMA MULTIPLO REFRATTARIO O RECIDIVATO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10051381
    E.1.2Term Myeloma recurrence
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine if there is an improvement in progression-free survival (PFS) when siltuximab is added to VELCADE (bortezomib) and dexamethasone in subjects with relapsed or refractory multiple myeloma.
    L'obiettivo primario di questo studio e' stabilire se l'aggiunta di siltuximab al regime composto da VELCADE (bortezomib) e desametasone determina un miglioramento della sopravvivenza libera da progressione (PFS) in soggetti con mieloma multiplo recidivante o refrattario.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess safety, additional measures of clinical benefit, patientreported outcomes (PROs), pharmacokinetics of dexamethasone and siltuximab, antibodies to siltuximab (immunogenicity), exploratory biomarkers, and health economic outcomes.
    Gli obiettivi secondari di questo studio sono la valutazione dei seguenti aspetti: sicurezza, misure supplementari del beneficio clinico, esiti riferiti dai pazienti (PRO), farmacocinetica di desametasone e siltuximab, anticorpi a siltuximab (immunogenicita'), biomarcatori esplorativi ed esiti in ambito economico-sanitario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential subjects must satisfy all of the following criteria to be enrolled in the study: • ≥ 18 years of age • Confirmed diagnosis of multiple myeloma requiring treatment • Measurable secretory disease, defined as either serum M-protein ≥ 1 g/dL or urine M-protein (light chain) ≥ 200 mg/24 hours • Must have received 1 to 3 lines of prior treatment for multiple myeloma (a single line of treatment may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy) • Must have achieved a response (MR or better) to at least 1 prior line of treatment • Must have progressed on (including relapse from CR) or be refractory (defined as < MR or disease progression within 60 days of last dose) to the most recent line of treatment. Progression or relapse is defined by any of the following: o Reappearance of measurable disease (as defined above) following CR o ≥ 25% increase in serum or urine M-protein o Development of new or worsening lytic bone disease o New plasmacytomas or ≥ 50% increase in the longest dimension of an existing plasmacytoma o Worsening hypercalcemia (corrected serum Ca > 11.5 mg/dL [2.8 mmol/L]) due to multiple myeloma • Subjects must not be refractory to any previous line of treatment that included a proteasome inhibitor • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 • Clinical laboratory test values meeting the following criteria: o Hemoglobin ≥ 8 g/dL(≥ 4.96 mmol/L) without transfusion support within 7 days before the laboratory test o Absolute neutrophil count (ANC) ≥ 1.0 x 109/L o Platelet count ≥ 50 x 109/L without transfusion support within 7 days before the laboratory test o AST ≤ 2.5 x ULN o ALT ≤ 2.5 x ULN o Total bilirubin ≤ x 1.5 ULN o Calculated creatinine clearance ≥ 20 mL/min o Corrected serum calcium < 14.0 mg/dL (3.5 mmol/L) • Women of childbearing potential must agree to use adequate birth control measures during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test (serum or urine β- human chorionic gonadotropin [β -HCG]) at screening • Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing/able to adhere to the prohibitions and restrictions specified in this protocol. Informed consent must be obtained before performing any study specific procedures.
    Per essere arruolati nello studio, i potenziali soggetti devono soddisfare tutti i criteri elencati di seguito. • &gt;18 anni di eta'. • Diagnosi confermata di mieloma multiplo che necessita il trattamento. • Malattia secernente misurabile, definita come proteina M nel siero &gt;1 g/dl o come proteina M nell’urina (catena leggera) &gt;200 mg/24 ore. • Da 1 a 3 linee precedenti di trattamento per il mieloma multiplo (una singola linea di trattamento puo' essere composta da uno o piu' agenti e puo' includere l'induzione, il trapianto di cellule staminali ematopoietiche e la terapia di mantenimento). • Ottenimento di una risposta (risposta minima [MR] o migliore) ad almeno una linea precedente di trattamento. • Progressione (inclusa la recidiva dopo la risposta completa [CR]) o refrattarieta' (definita come &lt; MR o progressione della malattia entro 60 giorni dall'ultima dose) alla linea di trattamento piu' recente. La progressione o recidiva e' definita da uno qualsiasi dei seguenti elementi: - ricomparsa di malattia misurabile (secondo la precedente definizione) dopo una CR; - aumento ≥25% della proteina M nel siero o nell'urina; - sviluppo di una nuova patologia ossea di tipo litico o aggravamento della patologia esistente; - nuovi plasmocitomi o aumento ≥50% della dimensione piu' lunga di un plasmocitoma esistente; - aggravamento dell'ipercalcemia (calcemia sierica corretta &gt;11,5 mg/dl [2,8 mmol/l]) a causa del mieloma multiplo. • Non refrattarieta' ad alcuna linea precedente di trattamento, comprendente un inibitore del proteasoma. • Stato di performance ECOG (Eastern Cooperative Oncology Group) pari a 0, 1 o 2 (vedere l'Allegato 1). • Valori delle analisi cliniche di laboratorio conformi ai seguenti criteri: - emoglobina ≥8 g/dl (≥4,96 mmol/l) senza supporto trasfusionale entro i 7 giorni precedenti alle analisi di laboratorio; - conta assoluta dei neutrofili (ANC) ≥1,0 x 109/l; - conta piastrinica ≥50 x 109/l senza supporto trasfusionale entro i 7 giorni precedenti alle analisi di laboratorio; - AST ≤ 2,5 x ULN; - ALT ≤ 2,5 x ULN; - bilirubina totale ≤1,5 x ULN; - clearance della creatinina calcolata ≥20 ml/min. (vedere l'Allegato 2); - calcemia sierica corretta &lt;14,0 mg/dl (3,5 mmol/l). • Le donne in eta' fertile devono accettare di adottare delle misure contraccettive adeguate durante lo studio e per i 3 mesi successivi all'assunzione dell'ultima dose di farmaco sperimentale; inoltre devono avere un test di gravidanza negativo (test della gonadotropina corionica umana [ß-HCG] nel sangue o nelle urine) allo screening. • Gli uomini devono accettare di adottare un metodo contraccettivo a doppia barriera e non devono donare lo sperma durante lo studio e per i 3 mesi successivi all'ultima dose di farmaco sperimentale. • I soggetti devono aver firmato un modulo di consenso informato indicante che hanno compreso lo scopo dello studio e le relative procedure, che intendono prendervi parte e che sono intenzionati/capaci di attenersi ai divieti e alle limitazioni specificati nel protocollo. E' necessario ottenere il consenso informato prima di ogni procedura specifica dello studio.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study: o Diagnosis of primary amyloidosis, plasma cell leukemia, or other conditions in which a paraprotein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions o Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 o Allogeneic bone marrow transplantation within 28 days before the first dose of study agent. Subjects for whom bone marrow transplant is planned within 12 months after study start are also ineligible. o Chemotherapy or radiation therapy within 21 days before the first dose of study agent (42 days for nitrosoureas) o Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity o Major surgery including open biopsy (excluding bone marrow) within 21 days before study treatment or planning to have surgery (except for minor surgical procedures) during the study (kyphoplasty is not considered major surgery) o Previous or concurrent malignancies other than multiple myeloma, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer from which the subject has been disease-free for ≥ 3 years o Concurrent medical condition (eg, acute pulmonary infiltrative disease, autoimmune disease, 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 the study. This includes subjects who the investigator believes would not tolerate starting doses of VELCADE or dexamethasone. o Significant cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias, or congestive heart failure (NYHA Class III or IV) or myocardial infarction within 6 months before the first dose of study agent o Vaccination with live attenuated vaccines within 4 weeks of the first administration of study agent o Known, unmanageable severe infusion related reactions to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients o Prior exposure to agents targeting IL-6 or the IL-6 receptor o Received any investigational agent (including vaccines) within 30 days before the first dose of study agent o Pregnant or breast-feeding
    I potenziali soggetti che soddisfino uno qualsiasi dei seguenti criteri saranno esclusi dalla partecipazione allo studio. • Diagnosi di amiloidosi primaria, leucemia delle cellule plasmatiche o altre condizioni nelle quali e' presente una paraproteina in assenza di infiltrazione di cellule plasmatiche clonali con lesioni ossee di tipo litico. • Neuropatia periferica di grado 1 associata a dolore o neuropatia periferica di grado 2 o superiore, secondo i criteri terminologici comuni per gli eventi avversi del National Cancer Institute (NCI-CTCAE), versione 4.0. • Trapianto di midollo osseo allogenico entro i 28 giorni precedenti alla prima dose di farmaco sperimentale. Non sono idonei inoltre i soggetti per i quali e' previsto un trapianto di midollo osseo nei 12 mesi successivi all'inizio dello studio. • Chemioterapia o radioterapia entro i 21 giorni precedenti alla prima dose di farmaco sperimentale (42 giorni per le nitrosuree). • Infezione clinicamente significativa, inclusa l'infezione nota da HIV o epatite C, o positivita' nota per antigene di superficie dell'epatite B. • Intervento chirurgico importante, tra cui biopsia aperta (ad esclusione del midollo osseo) entro i 21 giorni precedenti al trattamento dello studio oppure intervento chirurgico (ad esclusione di procedure chirurgiche di lieve entita') da eseguire durante lo studio (la cifoplastica non e' considerata un intervento chirurgico importante). • Neoplasie maligne precedenti o concomitanti diverse dal mieloma multiplo, eccetto carcinoma cutaneo a cellule basali o squamose, carcinoma della cervice in situ o altri carcinomi adeguatamente trattati, che non si manifestano piu' da ≥ 3 anni. • Condizione medica concomitante (ad es., pneumopatia infiltrativa acuta, malattia autoimmune, infezione sistemica attiva), incline a interferire con le procedure o i risultati dello studio oppure che, secondo lo sperimentatore, potrebbe costituire un rischio per la partecipazione allo studio. Questo criterio include anche i soggetti che, secondo lo sperimentatore, non riuscirebbero a tollerare le dosi iniziali di VELCADE o desametasone. • Cardiopatia significativa caratterizzata da coronaropatia ischemica significativa, aritmie significative o insufficienza cardiaca congestizia (classe NYHA III o IV) o infarto miocardico entro i 6 mesi precedenti alla prima dose di farmaco sperimentale. • Vaccinazione con vaccini attenuati vivi entro le 4 settimane precedenti alla prima somministrazione di farmaco sperimentale. • Gravi reazioni associate all'infusione note e non gestibili agli anticorpi monoclonali o alle proteine murine, chimeriche o umane o ai relativi eccipienti. • Precedente esposizione ad agenti che colpiscono l'IL-6 o il recettore dell'IL-6. • Assunzione di un farmaco sperimentale (inclusi i vaccini) entro i 30 giorni precedenti alla prima dose di farmaco dello studio. • Gravidanza o allattamento al seno.
    E.5 End points
    E.5.1Primary end point(s)
    The study will end at the time of the final analysis, which will be after 280 deaths have been recorded. This is expected to occur approximately 5 years after the first subject starts study treatment. Subjects who are benefiting from treatment (complete response [CR] or partial response [PR]) at the end of study may be eligible to receive siltuximab in a separate protocol.
    Lo Studio terminera' al momento dell'analisi finale che avverra' al ragiungimento dei 280 decessi. E' previsto che cio' accada circa 5 anni dopo l'inizio del trattamento dello studio da parte del primo soggetto. I soggetti che beneficiano del trattamento (CR o PR) alla fine dello studio possono essere elegibili per ricevere il farmaco in uno studio separato
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    China
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Turkey
    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 study will end when the final analysis of overall survival occurs (i.e. after 280 deaths have been recorded). This is expected to happen approximately 5 years after the first subject starts study treatment.
    Lo Studio terminera' al momento dell'analisi finale che avverra' al ragiungimento dei 280 decessi. E' previsto che cio' accada circa 5 anni dopo l'inizio del trattamento dello studio da parte del primo soggetto.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 500
    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 Decision2011-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-08
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