Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000268-17
    Sponsor's Protocol Code Number:CC-4047-MM-007
    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:2021-06-17
    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 number2014-000268-17
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY
    MULTIPLE MYELOMA
    Studio di fase 3, multicentrico, randomizzato, in aperto, per confrontare l¿efficacia e la sicurezza di pomalidomide somministrata con bortezomib e desametazone a basse dosi rispetto a bortezomib somministrato con desametazone a basse dosi 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 of the efficacy and safety of the combination of pomalidomide-bortezomib-low-dose dexamethasone compared to just the combination of bortezomib-low-dose dexamethasone in subjects with multiple myeloma that have relapsed after treatment or that have not responded to previous therapy
    Uno studio sull¿efficacia e la sicurezza della combinazione di pomalidomide-bortezomib-desametazone a basse dosi rispetto alla sola combinazione di bortezomid-desametazone a basse dosi in soggetti con mieloma multiplo che hanno avuto una recidiva dopo il trattamento o che non hanno risposto alla terapia precedente
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCC-4047-MM-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01734928
    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 SponsorCELGENE CORPORATION
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 90
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 Yes
    D.2.1.1.1Trade name Imnovid 1mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    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/3/09/672
    D.3 Description of the IMP
    D.3.1Product namepomalidomide
    D.3.2Product code [pomalidomide]
    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 INNPomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.3Other descriptive namePomalidomide
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 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: 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 Imnovid 2 mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    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/3/09/672
    D.3 Description of the IMP
    D.3.1Product namepomalidomide
    D.3.2Product code [pomalidomide]
    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 INNPomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.3Other descriptive namePomalidomide
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 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.2.1.1.1Trade name Imnovid 3 mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    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/3/09/672
    D.3 Description of the IMP
    D.3.1Product namepomalidomide
    D.3.2Product code [pomalidomide]
    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 INNPomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.3Other descriptive namePomalidomide
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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 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: 4
    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 Imnovid 4 mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    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/3/09/672
    D.3 Description of the IMP
    D.3.1Product namepomalidomide
    D.3.2Product code [pomalidomide]
    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 INNPomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.3Other descriptive namePomalidomide
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 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: 5
    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 Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Pharmaceutica NV
    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 nameBortezomib
    D.3.2Product code [Bortezomib]
    D.3.4Pharmaceutical form Powder for 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 INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.2Current sponsor code0
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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 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: 6
    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 Desametasone compresse BP 2,0 mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon Laboratories Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDesametasone
    D.3.2Product code [Desametasone]
    D.3.4Pharmaceutical form Tablet
    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 INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor code0
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 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: 7
    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 Desametasone-ratiopharm¿ 4 mg compresse
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDesametasone
    D.3.2Product code [Desametasone]
    D.3.4Pharmaceutical form Tablet
    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 INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor code0
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 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: 8
    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 Desametasone compresse BP 2,0 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameDesametasone
    D.3.2Product code [Desametasone]
    D.3.4Pharmaceutical form Tablet
    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 INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor code--
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 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
    relapsed or refractory multiple myeloma (MM)
    mieloma multiplo (MM) recidivante o refrattario
    E.1.1.1Medical condition in easily understood language
    (Blood cancer) certain blood cells multiply abnormally in the bone
    marrow, impair the production of other blood cells and produce proteins
    that cumulate in other organs impairing their functioning
    (Cancro del sangue)alcuneCell del sangue siMoltiplicano in modoAnormalo nelMidol osseo,Compromettono la produzDiAltreCelldelSangue eProducProtCheSiAccumulanoInAltriOrganiCompromettendone ilFunzionam
    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 compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM
    Confrontare l¿efficacia di POM + BTZ + LD-DEX rispetto a BTZ + LD-DEX nei soggetti con MM recidivante o refrattario
    E.2.2Secondary objectives of the trial
    To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with relapsed or refractory MM
    Valutare la sicurezza e l¿efficacia aggiuntiva di POM + BTZ + LD-DEX rispetto a BTZ + LD-DEX nei soggetti con MM recidivante o refrattario
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be = 18 years at the time of signing the informed consent form.
    2. The subject must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures.
    3. Must be able to adhere to the study visit schedule and other protocol requirements.
    4. Subjects must have documented diagnosis of multiple myeloma and have measurable disease by serum or urine protein electrophoresis
    (sPEP or uPEP): sPEP = 0.5 g/dL or uPEP = 200 mg/24 hours.
    5. All subjects must have had at least 1 but no greater than 3 prior antimyeloma regimens. (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen.)
    6. All subjects must have documented disease progression during or after their last anti-myeloma therapy.
    7. All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
    8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
    9. Females of childbearing potential (FCBP†) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 4 weeks before starting study treatment, while participating in the study treatment phase (including dose interruptions), and for at least 4 weeks after the last dose of POM or 3 months after the last dose of BTZ, whichever is longer, and must agree to regular pregnancy testing during this timeframe.
    10. Females must agree to abstain from breastfeeding during study treatment and 4 at least weeks after study treatment discontinuation.
    11. Males must agree to use a latex or synthetic condom during any sexual contact with FCBP while participating in the study treatment phase and for at least 4 weeks after the last dose of POM or 3 months after the last dose of BTZ, whichever is longer, even if he has
    undergone a successful vasectomy.
    12. Males must also agree to refrain from donating sperm while on pomalidomide and for 4 weeks after discontinuation from this study treatment.
    13. All subjects must agree to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment.
    14. All subjects must agree not to share medication.
    1. Età = 18 anni al momento della firma del modulo di consenso informato.
    2. Il soggetto deve comprendere e firmare volontariamente un documento di consenso informato prima qualsiasi valutazione/procedura correlata allo studio.
    3. Deve essere in grado di aderire al programma delle visite dello studio e ad altri requisiti del protocollo.
    4. I soggetti devono avere una diagnosi documentata di mieloma multiplo ed avere una malattia misurabile mediante elettroforesi delle proteine del siero o delle urine (sPEP o uPEP): sPEP = 0,5 g/dl o uPEP = 200 mg/24 ore.
    5. Tutti i soggetti devono aver avuto almeno 1 ma non più di 3 regimi anti-mieloma precedenti (nota: l’induzione con o senza trapianto di midollo osseo e con o senza terapia di mantenimento è considerato un regime)
    6. Tutti i soggetti devono avere una progressione della malattia documentata durante o dopo l’ultima terapia anti-mieloma.
    7. Tutti i soggetti devono aver ricevuto un trattamento precedente con un regime a base di lenalidomide per almeno 2 cicli consecutivi.
    8. Punteggio del perfomance status ECOG (European Cooperative Oncology Group) di 0, 1 o 2.
    9. Le donne potenzialmente fertili (FCBP+) devono acconsentire ad utilizzare due metodi contraccettivi affidabili contemporaneamente o praticare l’astinenza completa dal contatto eterosessuale per almeno 4 settimane prima di iniziare il trattamento dello studio, mentre partecipano allo fase di trattamento delo studio (comprese le interruzioni di dosaggio) e per almeno 4 settimane dopo l’ultima dose di POM o 3 mesi dopo l'ultima dose di BTZ, a seconda di quale delle due si verifica più tardi, e devono acconsentire a sottoporsi a regolari test di gravidanza durante questo periodo di tempo.
    10. Le pazienti di sesso femminile devono acconsentire ad astenersi dall’allattare durante il trattamento dello studio e per almeno 4 settimane dopo l’interruzione del trattamento dello studio.
    11. I pazienti di sesso maschile devono acconsentire ad utilizzare profilattici di lattice o sintetici durante qualsiasi contatto sessuale con donne potenzialmente fertili mentre partecipano alla fase di trattamento dello studio e per almeno 4 settimane dopo l'ultima dose di POM o 3 mesi dopo l'ultima dose di BTZ, a seconda di quale delle due si verifica più tardi, anche in caso di vasectomia eseguita con successo.
    12. I pazienti di sesso maschile devono anche acconsentire a non donare lo sperma mentre assumono pomalidomide e per 4 settimane dopo l’interruzione del trattamento di questo studio.
    13. Tutti i soggetti devono acconsentire a non donare sangue mentre assumono il trattamento dello studio e per 4 settimane dopo l’interruzione del trattamento di questo studio.
    14. Tutti i soggetti devono acconsentire a non condividere i medicinali.
    E.4Principal exclusion criteria
    1. Subjects who had documented progressive disease during therapy or
    within 60 days of the last dose of a bortezomib-containing therapy under
    the 1.3 mg/m2 dose twice weekly dosing schedule
    2. Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within
    14 days prior to randomization
    3. Non-secretory multiple myeloma
    4. Any of the following laboratory abnormalities:
    • Absolute neutrophil count (ANC) < 1,000/µL
    • Hemoglobin < 8 g/dL (< 4.9 mmol/L)
    • Platelet count < 75,000/µL for subjects in whom < 50% of bone
    marrow nucleated cells are plasma cells; or a platelet count < 30,000/
    µL for subjects in whom = 50% of bone marrow nucleated cells are
    plasma cells
    • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
    • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
    • Serum total bilirubin > 1.5 x ULN
    5. Subjects with severe renal impairment (Creatinine Clearance [CrCl]
    <30 mL/min) requiring dialysis
    6. Subjects with prior history of malignancies, other than MM, unless the
    subject has been free of the disease for = 5 years with the exception of
    the following non-invasive malignancies:
    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer (T1a or T1b using the
    TNM [tumor, nodes, metastasis] clinical staging system) or prostate
    cancer that is curative.
    7. Previous therapy with pomalidomide
    8. History of anaphylaxis or hypersensitivity to thalidomide,
    lenalidomide, bortezomib, boron, mannitol, or dexamethasone
    9. = Grade 3 rash during prior thalidomide or lenalidomide therapy
    10. Incidence of gastrointestinal disease that may significantly alter the
    absorption of pomalidomide
    11. Subjects with any one of the following:
    • Clinically significant abnormal ECG finding at screening
    • Congestive heart failure (New York Heart Association Class III or IV)
    • Myocardial infarction within 12 months prior to starting study
    treatment
    • Unstable or poorly controlled angina pectoris, including Prinzmetal
    variant angina pectoris
    12. Subjects who received any of the following within the last 14 days of
    initiation of study treatment:
    • Plasmapheresis
    • Major surgery (kyphoplasty is not considered major surgery)
    • Radiation therapy other than local therapy for myeloma associated
    bone lesions
    • Use of any systemic anti-myeloma drug therapy
    13. Use of any investigational agents within 28 days or 5 half-lives
    (whichever is longer) of treatment
    14. Subjects with conditions requiring chronic steroid or
    immunosuppressive treatment, such as rheumatoid arthritis, multiple
    sclerosis, and lupus, which likely need additional steroid or
    immunosuppressive treatments in addition to the study treatment.
    Includes subjects receiving corticosteroids (> 10 mg/day of prednisone
    or equivalent) within 3 weeks prior to enrollment.
    15. Subjects unable or unwilling to undergo protocol required
    thromboembolism prophylaxis or herpes zoster prophylaxis will not be
    eligible to participate in this study
    16. Any condition, including the presence of laboratory abnormalities,
    which places the subject at unacceptable risk if he/she were to
    participate in the study
    17. Any serious medical condition, laboratory abnormality, or psychiatric
    illness that would prevent the subjects from signing the informed
    consent form
    18. Pregnant or breastfeeding females
    19. Known seropositive for or active viral infection with human
    immunodeficiency virus (HIV)
    1. I Soggetti che hanno una malattia progressiva documentata durante la terapia o
    entro 60 giorni dall'ultima dose di una terapia
    contenente bortezomib con un regime di trattamento di 1,3 mg/m2 due volte alla
    settimana
    2. Neuropatia periferica di Grado 3, Grado 4 o Grado 2 con dolore entro 14 giorni prima della randomizzazione.
    3. Mieloma multiplo non secretorio
    4. Una delle seguenti anomalie di laboratorio:• Conta assoluta dei neutrofili (ANC) < 1.000/µI
    • Emoglobina < 8 g/dl ( <4,9 mmol/1)• Conta piastrinica < 75.000/µI per i soggetti in cui < 50% delle cellule nucleate del midollo osseo sono plasmacellule; o conta delle
    piastrine < 30.000/µI per i soggetti in cui ¿ 50% delle cellule nucleate del midollo osseo sono plasmacellule
    • Calcio sierico corretto > 13,5 mg/di (> 3,4 mmol/1)
    • SGOT/AST o SGPT/ALT sierica > 3,0 xii limite normale superiore (ULN)
    • Bilirubina totale sierica > 1,5 x ULN
    5. Soggetti con compromissione renale grave (clearance della creatinina [CrCI] < 30 ml/min) che necessitano di dialisi
    6. Soggetti con anamnesi precedente di neoplasie maligne, diverse dal MM, a meno che ii soggetto sia state libero da malattia per
    ¿ 5 anni con l'eccezione delle seguenti neoplasie maligne non invasive:
    • Carcinoma cutaneo a cellule basali
    • Carcinoma cutaneo a cellule squamose
    • Carcinoma in situ della cervice
    • Carcinoma in situ della mammella
    • Rilevazione istologica incidentale del cancro della prostata (T1a o Tlb usando ii sistema di stadiazione cllnica TNM [tumore,
    nodull, metastasi]) o cancro della prostata curabile.
    7 .Terapia precedente con pomalidomide
    8. Anamnesi di anafilassi o ipersensibilita a talidomide, lenalidomide, bortezomib, boron, mannitolo o desametasone.
    9. Eruzione cutanea di grade ¿ 3 durante una terapia precedente con talidomide o lenalidomide
    10. Incidenza di malattia gastrointestinale che puo alterare significativamente l'assorbimento delia pomalidomide.
    11. Soggettl con una delle seguenti condizioni:
    • ECG significativamente anormale dal punto di vista clinico allo screening
    • Insufflcienza cardiaca congestizia (Classe III o IV della New York Heart Association)
    • Infarto del miocardio entro 12 mesi prima dell'inizio del trattamento dello studio.
    • Angina pectoris instabile o scarsamente controllata, compresa la variante Prinzmetal dell'angina pectoris
    12.I soggettl che hanno ricevuto uno dei seguenti trattamenti nei 14 giorni precedenti l'inizio del trattamento dello studio:
    • Plasmaferesi
    • Intervento chirurgico importante (la vertebroplastica non e considerato un intervento chirurgico importante)
    • Radioterapia diversa dalla terapia locale per le lesioni ossee associate al mieloma
    • Utilizzo di qualsiasi terapia farmacologica sistemica anti mieloma
    13. Utilizzo di qualsiasi agente sperimentale entro 28 giorni o 5 emivite (a seconda di quale e superiore) del trattamento.
    14. Soggetti con condizioni che richiedono ii trattamento cronico con steroidi o immunosoppressivo, quali l'artrite reumatoide, la
    sclerosi multipla e ii lupus, che probabilmente necessiteranno di trattamenti aggiuntivi con steroide o immunosoppressivo oltre al
    trattamento In studio. Questa comprende i soggetti che hanno ricevuto corticosteroidi (> 10 mg/giorno di prednisone o
    equivalente) entro 3 settimane prima dell'arruolamento.
    15. I soggettl incapaci o riluttanti a sottoporsi alla profilassi per la tromboembolia o
    !'herpes zoster richiesta dal protocollo non
    saranno idonei a partecipare a questo studio.
    16. Qualsiasi condizione, compresa la presenza di anomalie di laboratorio che ponga ii soggetto ad un rischio inaccettabile se
    partecipasse allo studio.
    17. Qualsiasi condizione medica grave, anomalie di laboratorio o malattia psichiatrica che impedirebbe al soggetto di firmare ii
    consenso informato.
    18. Donne in state di gravidanza o che allattano con latte materno
    19. Sieropositivita nota per ii virus dell'immunodeficienza umana (HIV) o infezione attiva di tale virus.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS)
    Progressione libera da malattia (PFS, progression free survival)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be assessed by:
    - Bone Marrow Aspiration and/or Biospy – Screening and as Clinically indicated or to confirm CR
    - Quantitative Serum Immunoglobulins, serum-protein electrophoresis (sPEP), 24-hour urine protein electrophoresis, serum and urine
    immunofixation, serum free light-chain assay, and extramedullary plasmacytoma (EMPs) at Screening and Day 1 of each cycle and PFS Follow-up (if applicable). If EMPs are only assessable radiographically, scans are to be conducted at Screening, C3D1, every 3 cycles thereafter
    during treatment, at treatment discontinuation, every 63 days (3 cycles) during the PFS follow-up phase, at PFS follow-up phase discontinuation,
    and when clinically indicated to confirm response (> or = PR)
    -Skeletal Surveys – Screening and when clinically indicated
    La PFS sara valutata medlante
    - Aspirate di mldollo osseo e/o biopsia - screening e come indicate clinicamente o per confermare la CR
    - Immunoglobuline sieriche quantitative, elettroforesi delle proteine sieriche (sPEP), elettroforesi proteine delle urine delle 24 ore,
    immunofissazione del siero e delle urine, dosaggio delle catene libere leggere nel siero e plasmacitomi extramidollari (EMP) allo
    Screening e al Giorno 1 di ciascun ciclo e follow-up della PFS (se pertinente). Se gli EMP sono valutabili solo radiologicamente,
    devono essere eseguite delle scansioni allo Screening, C3G1, ogni 3 cicli successivamente durante ii trattamento, alla fine del trattamento
    E.5.2Secondary end point(s)
    -Overall Survival (OS)
    -Safety (type, frequency, seriousness and severity of AEs, and relationship of AEs to study drug or comparator)
    -Overall response rate (ORR) (using the International Myeloma Working Group Uniform [IMWG] response criteria)
    -Duration of response
    - Sopravvivenza complessiva (OS)
    - Sicurezza (tipo, frequenza, seriet¿ e gravit¿ degli EA e relazione degli EA con il farmaco in studio o con il comparatore)
    - Tasso di risposta complessiva (ORR, overall response rate) (usando i criteri uniformi di risposta IMWG (International Myeloma Working Group)
    - Durata della risposta
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: All long-term follow-up phase subjects will be contacted four (4) times a year (every 3 months) to obtain survival status for at least 5 years after the last subject is randomized into the study, or longer if
    clinically indicated
    Safety: i. AEs: After signing ICF and until 28 days after treatment discontinuation; ii. SPM: After signing ICF up to and including the longterm
    follow-up period and up to 5 years after last subject enrolled
    Overall Response Rate (ORR): when assessable
    Duration of Response: when assessable
    OS: tutti i soggetti della fase di follow-up a lungo termine saranno contattati quattro (4) volte all¿anno (ogni 3 mesi) per verificare lo stato di sopravvivenza per almeno 5 anni dopo che l¿ultimo soggetto ¿ stato randomizzato nello studio, o pi¿ a lungo se indicato clinicamente.
    Sicurezza: i. ¿EA: dopo aver firmato il modulo di consenso informato e fino a 28 giorni dopo l¿interruzione del trattamento; ii. ¿ SPM: dopo aver firmato il modulo di consenso informato e fino al periodo di follow-up a lungo termine, questo compreso, e fino a 5 anni dopo l¿arruolamento dell¿ultimo soggetto.
    Tasso di risposta complessivo (ORR, overall response rate): quando valutabile
    Durata della risposta: quando valutabile
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Israel
    Japan
    Korea, Republic of
    Mexico
    Puerto Rico
    Taiwan
    Turkey
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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 Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, whichever is the later date as prespecified in the protocol and/or the Statistical Analysis Plan
    La fine dello studio ¿ definita come la data dell¿ultima visita dell¿ultimo soggetto che ha completato lo studio, o la data del ricevimento degli ultimi dati previsti dall¿ultimo soggetto che sono richiesti per l¿analisi primaria, secondaria e/o esplorativa, a seconda di quale evento si verifica dopo, come pre specificato nel protocollo e/o nel piano di analisi statistica
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    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.1.1.1In 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: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 327
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 407
    F.4.2.2In the whole clinical trial 559
    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)
    The treatment after the trial will be at investigator's discretion.
    Il trattamento dopo la sperimentazione sar¿ a discrezione dello sperimentatore.
    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 Decision2015-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 10:55:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA