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    Summary
    EudraCT Number:2010-020454-34
    Sponsor's Protocol Code Number:20090482
    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:2012-06-15
    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 number2010-020454-34
    A.3Full title of the trial
    A Randomized, Double-Blind, Multicenter Study of Denosumab Compared
    With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in
    Subjects with Newly Diagnosed Multiple Myeloma
    Studio multicentrico randomizzato in doppio cieco sull'utilizzo di denosumab confrontato con acido zoledronico (Zometa) nel trattamento di patologie ossee in soggetti con nuova diagnosi di mieloma multiplo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease
    in Subjects With Multiple Myeloma
    Denosumab confrontato con acido zoledronico nel trattamento di patologie ossee in soggetti con mieloma multiplo
    A.4.1Sponsor's protocol code number20090482
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01345019
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Dompe' SpA
    B.5.2Functional name of contact pointDipartimento Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Tazzoli, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02624 112 367
    B.5.5Fax number+39 02 2900 5596
    B.5.6E-mailgbotta@amgendompe.it
    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 XGEVA
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDENOSUMAB
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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 Zometa
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNACIDO ZOLEDRONICO
    D.3.9.1CAS number 118072-93-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.8
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate 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
    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 14.1
    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
    To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE)in subjects with multiple myeloma
    Determinare la non inferiorita' di denosumab rispetto all'acido zoledronico per quanto riguarda il primo caso nello studio di un evento relativo all'apparato scheletrico (SRE) in soggetti con mieloma multiplo
    E.2.2Secondary objectives of the trial
    - To determine if denosumab is superior to zoledronic acid with respect to the first on-study SRE; - To determine if denosumab is superior to zoledronic acid with respect to the first and subsequent on-study SRE (multiple event analysis); - To assess the treatment effects of denosumab and zoledronic acid on progression-free survival and overall survival; - To assess the safety and tolerability of denosumab compared with zoledronic acid.
    - Determinare se denosumab e' superiore all'acido zoledronico per quanto riguarda il primo SRE durante lo studio- Determinare se denosumab e' superiore all'acido zoledronico per quanto riguarda il primo e i successivi SRE durante lo studio (analisi di eventi multipli)- Valutare gli effetti del trattamento con denosumab e con acido zoledronico sulla sopravvivenza in assenza di progressione e sulla sopravvivenza complessiva- Valutare la sicurezza e la tollerabilita' di denosumab rispetto all'acido zoledronico
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:-NA
    Date:2011/08/18
    Title:Pharmacokinetic sub-study
    Objectives:The purpose of this sub-study is to evaluate the pharmacokinetic profile of denosumab when given at a dose of 120 mg every 4 weeks (Q4W) to newly diagnosed subjects with multiple myeloma. Not all sites will be involved in the substudy. Not all site will be involved in the sub-study. Please refer to the protocol for further details

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:-NA
    Data:2011/08/18
    Titolo:Sottostudio di farmacocinetica
    Obiettivi:L’obiettivo di questo sottostudio e' di valutare il profilo farmacocinetico di denosumab quando viene somministrato ad un dosaggio di 120 mg ogni 4 settimane (Q4W) in soggetti con nuova diagnosi di mieloma multiplo. Non tutti i centri saranno coinvolti nel sottostudio. Per maggiori dettagli si rimanda al protocollo

    E.3Principal inclusion criteria
    - Adults with newly diagnosed multiple myeloma; - Radiographic evidence of at least 1 bone lesion; - Plan to receive primary frontline anti-myeloma therapies; - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; - Adequate organ function; - Written informed consent.
    - Soggetti adulti affetti da mieloma multiplo di nuova diagnosi, - Conferma radiografica di almeno una lesione ossea, - soggetto candidato a ricevere una terapia anti-mieloma di prima linea - Performance status secondo Estern Cooperative Oncology Group (ECOG) uguale a 0,1 o 2 - Adeguata funzionalita' degli organi; - Consenso informato scritto
    E.4Principal exclusion criteria
    - Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated); - Plasma cell leukemia; - Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome; - Previous treatment with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days]). Anti-myeloma therapy (excluding bisphosphonates) may be started before randomization if the subject has signed informed consent and screening blood samples have been collected for central analysis. - Planned radiation therapy or surgery to bone (does not include procedures; performed before randomization) - Prior administration of denosumab; - Prior or current IV bisphosphonate administration; - Use of oral bisphosphonates within the past 1 year; - Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw.
    - Mieloma multiplo non secretorio (a meno che al baseline il livello sierico di catene leggere libere sia elevato) - Leucemia delle cellule plasmatiche - Sindrome di POEMS (Polineuropatia, organomegalia, endocrinopatia, proteina monoclonale, e alterazione cutanea (POEMS)) - Precedenti trattamenti con terapia anti-mieloma ( che non includa la radioterapia o un unico ciclo breve di steroidi [cioe', un dosaggio Inferiore o uguale a 40 mg di desametasone al giorno per 4 giorni]). La terapia anti-mieloma (esclusi i bifosfonati) puo' essere iniziata prima della randomizzazione se il soggetto ha firmato il consenso informato e se i campioni di sangue siano gia' stati raccolti allo screening per le analisi centralizzate. - Radioterapia o intervento osseo programmati (che non include procedure eseguite prima della randomizzazione) - Soggetti che hanno gia' assunto denosumab - Soggetti che hanno gia' assunto o stanno assumendo bifosfonati IV - Uso di bifosfonati orali nell’anno precedente - Precedente storia o evidenza di osteonecrosi/osteomielite della mandibola.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first on-study SRE (non-inferiority) SRE is an aggregate endpoint that includes pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
    Tempo al primo SRE durante lo studio (non inferiorita'). Lo SRE e' un endpoint aggregato che include fratture patologiche (vertebrali e non), radioterapia alle ossa (compreso l'uso di radioisotopi), chirurgia ossea o compressione del midollo spinale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis cut-off date is event-driven (i.e. when approximately 800 subjects have experienced at least one on-study SRE)
    La cut-off date della prima analisi e' l'“event-driven” (i.e quando circa 800 pazienti hanno avuto almeno un SRE nello studio)
    E.5.2Secondary end point(s)
    - Time to the first on-study SRE (superiority); - Time to the first-and-subsequent on-study SRE (superiority, using multiple event analysis); Additional Secondary Endpoints: - Progression-free survival (PFS); - Overall survival (OS); Safety Endpoints: - Subject incidence of treatment emergent adverse events; - Changes in laboratory values; - Incidence of anti-denosumab antibody (binding and neutralizing) formation.
    - Tempo al primo SRE durante lo studio (superiorita') - Tempo al primo e ai successivi SRE durante lo studio (superiorita', usando l'analisi degli eventi multipli) Endpoint secondari aggiuntivi: - sopravvivenza senza progressione della malattia (PFS) - sopravvivenza complessiva (OS) Endpoint di sicurezza: - incidenza nei soggetti di eventi avversi causati dal trattamento - variazioni nei valori di laboratorio - incidenza della formazione di anticorpi anti-denosumab (legame e neutralizzazione)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary analysis cut-off date is event-driven (i.e. when approximately 800 subjects have experienced at least one on-study SRE)
    La cut-off date della prima analisi e' l'“event-driven” (i.e quando circa 800 pazienti hanno avuto almeno un SRE nello studio)
    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) 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 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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    European Union
    Australia
    Canada
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Malaysia
    New Zealand
    Russian Federation
    Singapore
    Switzerland
    Taiwan
    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
    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
    E.8.9.2In all countries concerned by the trial years6
    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.1.2.1Number of subjects for this age range: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 960
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1520
    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)
    NA
    NA
    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 Decision2012-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-29
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