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    Summary
    EudraCT Number:2010-022445-20
    Sponsor's Protocol Code Number:CA204006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-022445-20
    A.3Full title of the trial
    A Phase 3, Randomized, Open Label Trial of
    Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects
    with Previously Untreated Multiple Myeloma.
    Ensayo de fase 3, aleatorizado y abierto, de lenalidomida/dexametasona, con o sin elotuzumab, en sujetos con mieloma múltiple no tratados previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in
    Subjects with Previously Untreated Multiple Myeloma.
    Ensayo de lenalidomida/dexametasona, con o sin elotuzumab, en sujetos con mieloma múltiple no tratados previamente.
    A.4.1Sponsor's protocol code numberCA204006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01335399
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Start Up Department
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameElotuzumab
    D.3.2Product code HuLuc63
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNElotuzumab
    D.3.9.1CAS number 915296-00-3
    D.3.9.2Current sponsor codeBMS-901608
    D.3.9.3Other descriptive nameHuLuc63; Anti-CS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 typeAnticuerpo monoclonal humanizado de tipo IgG1. // Humanized monoclonal IgG1 antibody
    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 REVLIMID 5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/07/494
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INNLENALIDOMIDA
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameCC-5013, CDC-501
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente inmunomodulador
    D.IMP: 3
    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 REVLIMID 10 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/07/494
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INNLENALIDOMIDA
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameCC-5013, CDC-501
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente inmunomodulador
    D.IMP: 4
    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 REVLIMID 15 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/07/494
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INNLENALIDOMIDA
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameCC-5013, CDC-501
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente inmunomodulador
    D.IMP: 5
    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 REVLIMID 25 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/07/494
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INNLENALIDOMIDA
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameCC-5013, CDC-501
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente inmunomodulador
    D.IMP: 6
    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 Fortecortin 2 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Pharma 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 nameFortecortín
    D.3.2Product code 50-02-2
    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 INNDEXAMETASONA FOSFATO SODIO
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameDEXAMETHASONE SODIUM PHOSPHATE
    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 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.IMP: 7
    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 Dexametasona comprimidos 2 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 nameDexamethasone Tablet BP 2.0mg
    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 INNDEXAMETASONA
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    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 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.IMP: 8
    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.2.5The 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 nameDexametasona
    D.3.4Pharmaceutical form Injection
    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 INNDexametasona
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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.IMP: 9
    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.2.5The 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 nameDexametasona
    D.3.4Pharmaceutical form Injection
    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 INNDexametasona
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mieloma Múltiple no tratado previamente.
    E.1.1.1Medical condition in easily understood language
    El Mieloma Multiple es un tipo de cancer de las células sanguineas que afecta a los leucocitos productores de anticuerpos.
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the Progression-Free Survival of
    lenalidomide/dexamethasone + elotuzumab (LdE) versus
    lenalidomide/dexamethasone (Ld) in subjects with newly diagnosed,
    untreated multiple myeloma (MM).
    Comparar la SSP de lenalidomida/dexametasona + elotuzumab (LdE) frente a lenalidomida/dexametasona (Ld) en sujetos con mieloma múltiple (MM) de diagnóstico reciente no tratado previamente.
    E.2.2Secondary objectives of the trial
    -To compare objective response rate between treatment arms;
    -To compare overall survival between treatment arms.
    - To permit the collection and storage of blood samples
    for use in future exploratory pharmacogenetic research.
    Exploratory Objectives:
    -To assess safety in each arm;
    -For those subjects who achieve an objective response, to assess the
    time to tumor response and duration of response;
    -To assess the time to subsequent therapy in each arm;
    -To assess the Health-related Quality of Life (HRQOL) outcomes (EORTC
    QLQ-C30 and QLQ-MY20) and the Brief Pain Inventory- Short Form (BPI-SF);
    -To measure the serum concentrations of elotuzumab in the presence of
    lenalidomide and dexamethasone;
    -To evaluate the immunogenicity of elotuzumab.
    -To explore the relationship between the effectiveness of elotuzumab
    and high-risk cytogenetic factors and sMICA (soluble major histocompatibility complex class I-related chain A) levels.
    1) Comparar la tasa de respuesta objetiva entre los grupos de tratamiento
    2) Comparar la supervivencia global entre los grupos de tratamiento.
    3) Permitir la recogida y conservación de muestras de sangre para su uso en futuros estudios de investigación farmacogenética exploratorios.

    Objetivos exploratorios:
    Evaluar la seguridad en cada grupo;
    En los sujetos que alcancen una respuesta objetiva, evaluar el tiempo hasta la respuesta tumoral y la duración de la respuesta;
    Evaluar el tiempo hasta el tratamiento posterior en cada grupo;
    Evaluar los resultados de calidad de vida relacionada con la salud (EORTC QLQ-C30 y QLQ-MY20) y el inventario breve de dolor - forma abreviada (BPI-SF);
    Medir las concentraciones séricas de elotuzumab en presencia de lenalidomida y dexametasona;
    Evaluar la inmunogenia del elotuzumab.
    Explorar la relación entre la eficacia del elotuzumab y los factores citogenéticos de alto riesgo y los niveles de sMICA. (El HLA clase I soluble-cadena A)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Subject is, in the investigator's opinion, willing and able to comply
    with the protocol requirements.
    b) Subject has given voluntary written informed consent before
    performance of any study-related procedure not part of normal medical
    care, with the understanding that consent may be withdrawn by the
    subject at any time without prejudice to their future medical care.
    2) Target Population
    a) Age >or= 18 years or legal age of consent per local regulations.
    b) ECOG performance status <or= 2.
    c) Life-expectancy > 3 months.
    d) Newly diagnosed ,untreated, symptomatic, documented myeloma
    AND;
    i) Who are not candidates for high-dose therapy plus SCT because of
    age (>or= 65 years) or coexisting conditions AND;
    ii) Measureable disease: serum IgG, IgA, IgM M-protein >or= 0.5 g/dL
    or serum IgD M-protein >or= 0.05 g/dL or >or= 200 mg urinary Mprotein
    excretion /24-hour.
    3) Age and Reproductive Status
    a) Women of childbearing potential (WOCBP) and men must be using 2
    acceptable methods of contraception to avoid pregnancy throughout the
    study for a period of at least 1 month (4 weeks) before and women for
    up to 8 weeks, men for up to 90 days after the last dose of
    investigational product in such a manner that the risk of pregnancy is
    minimized.
    b) WOCBP must have a negative serum or urine pregnancy test
    (minimum sensitivity 25 IU/L or equivalent units of HCG). The first
    should be performed within 10 14 days and the second within 24 hours
    prior to the start of the investigational product. A prescription for
    lenalidomide for a female of childbearing potential must not be issued by
    the prescriber until negative pregnancy tests have been verified by the
    prescriber.
    c) Women must not be breastfeeding.
    d) Women who are not of childbearing potential and men.
    e) Sexually active fertile men must use effective birth control if their
    partners are WOCBP. Men must agree to use a latex condom and a
    second form of birth control during sexual contact with WOCBP, even if
    they have had a successful vasectomy, and must agree to not donate
    semen during study drug therapy and for 90 days after therapy.
    f) Subjects must be willing to refrain from blood donations during study
    drug therapy and for 8 weeks after therapy.
    4) To participate in this Pharmacogenetic Sample Amendment, subjects
    must provide a signed Pharmacogenetic Blood DNA informed consent
    and must have consented to participate in the main clinical trial
    CA204006.
    1)Consentimiento informado por escrito firmado
    a)En opinión del investigador, el sujeto está dispuesto y es capaz de cumplir los requisitos del protocolo.
    b)El sujeto ha otorgado voluntariamente su consentimiento informado por escrito antes de la realización de ningún procedimiento relacionado con el estudio que no forme parte de la asistencia médica normal, con el entendimiento de que el sujeto puede retirar su consentimiento en cualquier momento sin perjuicios para su atención médica futura.
    2)Población de interés
    a)Edad 18 años o edad legal de consentimiento según la reglamentación local.
    b)Estado funcional del ECOG 2.
    c)Esperanza de vida > 3 meses.
    d)Mieloma documentado de nuevo diagnóstico, no tratado, sintomático Y
    i)Que no sean candidatos a tratamiento con dosis altas más TCM por su edad ( 65 años) o a consecuencia de procesos concomitantes Y
    ii)Enfermedad mensurable: niveles séricos de proteína M de tipo IgG, IgA o IgM 0,5 g/dl o niveles séricos de proteína M de tipo IgD 0,05 g/dl o eliminación de proteína M en orina de 24 horas 200 mg.
    3)Sexo y estado reproductivo
    a)Las mujeres potencialmente fértiles y los hombres deben utilizar dos métodos anticonceptivos aceptables para evitar el embarazo a lo largo del estudio, desde por lo menos un mes (4 semanas) antes, y las mujeres hasta 8 semanas y los hombres hasta 90 días después de la última dosis del producto en investigación, de tal forma que se reduzca al mínimo el riesgo de embarazo. Véase la sección 3.3.3 para una definición de las mujeres potencialmente fértiles y las directrices del plan de manejo de riesgos de Revlimid.
    b)Las mujeres potencialmente fértiles deben presentar un resultado negativo en una prueba de embarazo en suero u orina (sensibilidad mínima de 25 UI/L o unidades equivalentes de HCG). La primera prueba debe realizarse en el plazo de los 10-14 días previos al comienzo del producto en investigación, y la segunda en las 24 horas anteriores a dicho comienzo. El médico no debe prescribir lenalidomida a una mujer potencialmente fértil hasta que haya verificado el resultado negativo de las pruebas de embarazo.
    c)Las mujeres no deben proporcionar lactancia materna.
    d)Mujeres que no sean potencialmente fértiles (es decir, posmenopáusicas o esterilizadas quirúrgicamente; véase la definición de mujeres potencialmente fértiles en la sección 3.3.3) y hombres.
    e)Los hombres fértiles y sexualmente activos deben utilizar un método anticonceptivo eficaz si sus parejas son mujeres potencialmente fértiles. Los hombres deben estar de acuerdo en utilizar un preservativo de látex y un segundo método anticonceptivo en sus relaciones sexuales con mujeres potencialmente fértiles, incluso aunque se hayan realizado una vasectomía satisfactoria, y deben comprometerse a no donar semen durante el tratamiento con el medicamento del estudio y en los 90 días siguientes al tratamiento.
    f)Los sujetos deben estar dispuestos a no donar sangre durante el tratamiento con el medicamento del estudio y en las 8 semanas siguientes al tratamiento.
    4)Para poder participar en este estudio para la obtención de una muestra de sangre para Farmacogenética, los sujetos deberán firmar un documento de consentimiento informado para la obtención del ADN de una muestra de sangre para farmacogenética, así como haber otorgado su consentimiento para participar en el ensayo clínico principal, CA204006.
    E.4Principal exclusion criteria
    1) Target Disease Exceptions
    a) Subjects with non-secretory or oligo-secretory or serum free lightchain only myeloma.
    b) Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions.
    c) Monoclonal Gammopathy of Undetermined Significance (MGUS) defined by all of the following: serum M protein < 3 g/dL, absence of lytic bone lesions, anemia, hypercalcemia and renal insufficiency related to monoclonal protein and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
    d) Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
    e) Plasma cell leukemia.
    2) Medical History and Concurrent Diseases
    a) Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
    b) Significant cardiac disease as determined by the investigator including:
    i) Known or suspected cardiac amyloidosis;
    ii) Congestive heart failure of Class III or IV of the NYHA classification;
    iii) Uncontrolled angina, hypertension or arrhythmia;
    iv) Myocardial infarction in past 6 months;
    v) Any uncontrolled or severe cardiovascular disease.
    c) Prior cerebrovascular event with persistent neurologic deficit.
    d) Known history of, or documented positive hepatitis B or C or HIV infection.
    e) Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject. Examples of such conditions include:
    i) Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder;
    ii) Active infection of Hepatitis A or that requires parenteral antiinfective treatment;
    iii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
    f) Prior or concurrent malignancy, except for the following:
    i) Adequately treated basal cell or squamous cell skin cancer;
    ii) Cervical carcinoma in situ;
    iii) Adequately treated Stage I or II cancer from which the subject is currently in complete remission;
    iv) Or any other cancer from which the subject has been disease-free for <or= 3 years.
    g) Uncontrolled diabetes.
    h) Unable to tolerate thromboembolic prophylaxis including, aspirin, Coumadin (warfarin) or low-molecular weight heparin as clinically indicated.
    3) Physical and Laboratory Test Findings
    a) Corrected serum calcium >or= 14 mg/dl within 2 weeks of randomization.
    b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of randomization.
    c) Platelets < 75,000 cell/mm3 (75 x 10E9/L). Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.
    d) Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.
    e) Total bilirubin >or= 2 x ULN, and direct bilirubin >or= 2.0 mg/dL.
    f) AST or ALT >or= 3 x ULN.
    g) Creatinine clearance (CrCl) < 30 mL/min measured by 24-hour urine
    collection or estimated by the Cockcroft and Gault formula.
    4) Prior Therapy or Surgery
    a) Administration of systemic chemotherapy, biological, immunotherapy, clarithromycin or any investigational agent (therapeutic or diagnostic) for multiple myeloma except bisphosphonate therapy.
    b) Treatment with plasmapheresis within 4 weeks prior to randomization.
    c) No steroids within 3 weeks of randomization, except:
    i) short course (of <or= 4 days) of 40 mg dexamethasone or equivalent for emergency use (baseline M proteins must be drawn after this short course and prior to randomization);
    ii) <or= 5 mg prednisone or equivalent per day;
    iii) Steroid with little to no systemic absorption (ie, topical or inhaled steroids).
    d) Major surgery within 4 weeks prior to randomization (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities.
    e) Radiation therapy within 2 weeks prior to randomization.
    5) Allergies and Adverse Drug Reaction
    a) Known hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation or recombinant protein.
    6) Sex and Reproductive Status
    a) Sexually active fertile men not using 2 forms of effective birth control if their partners are WOCBP.
    7) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated.
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
    1)Exclusiones por la enfermedad diana
    a)Sujetos con mieloma no secretor u oligosecretor o de cadenas ligeras libres en suero exclusivamente.
    b)MM quiescente, definido como un MM asintomático con ausencia de lesiones óseas líticas.
    c) Gammapatía monoclonal de significación indeterminada (GMSI), definida por todo lo siguiente: proteína M sérica < 3 g/dl, ausencia de lesiones óseas líticas, anemia, hipercalcemia e insuficiencia renal relacionada con la proteína monoclonal y (si se determina) porcentaje de células plasmáticas en médula ósea igual o inferior al 10%.
    d) Diagnóstico de enfermedad de Waldenstrom u otros proceso con proteína M de tipo IgM en ausencia de una infiltración de células plasmáticas clonales con lesiones óseas líticas.
    e) Leucemia de células plasmáticas (definida como un 20% de leucocitos periféricos consistentes en células plasmáticas/CD138+ o bien un recuento absoluto de 2 × 109/L).
    2) Antecedentes médicos y enfermedades concomitantes
    a) Amiloidosis cardiaca conocida o de sospecha; síndrome POEMS (discrasia de células plasmáticas con polineuropatía, organomegalia, endocrinopatía, proteína monoclonal y alteraciones cutáneas).
    b) Cardiopatía importante, a juicio del investigador, como:
    i) Amiloidosis cardiaca conocida o de sospecha
    ii) Insuficiencia cardiaca congestiva de clase III o IV de la clasificación NYHA
    iii) Angina, hipertensión o arritmia no controladas
    iv) Infarto de miocardio en los últimos 6 meses
    v) Cualquier enfermedad cardiovascular no controlada o severa
    c) Acontecimiento cerebrovascular previo con déficit neurológico persistente.
    d) Antecedentes conocidos o infección documentada por los virus de las hepatitis B o C o VIH.
    e) Cualquier trastorno médico que, en opinión del investigador, supondría un riesgo excesivo para el sujeto. Pueden citarse los siguientes ejemplos:
    i) Cualquier enfermedad no controlada, como neumopatía, infección, trastorno epiléptico
    ii) Infección activa por el virus de la hepatitis A o que precise un tratamiento antiinfeccioso parenteral
    iii) Cualquier alteración del estado mental o trastorno psiquiátrico que influyera en la comprensión del consentimiento informado
    f) Neoplasia maligna previa o concomitante, excepto las siguientes:
    i) Carcinoma cutáneo basocelular o espinocelular adecuadamente tratado
    ii) Carcinoma de cuello uterino in situ
    iii) Cáncer en estadio I o II adecuadamente tratado del que el sujeto se encuentre actualmente en remisión completa
    iv) Cualquier otro cáncer que haya presentado el sujeto con un periodo posterior sin enfermedad 3 años
    g) Diabetes no controlada (definida como una hemoglobina glicosilada [HbA1c] 8,0% y una glucosa en ayunas 160 mg/dl).
    h) Incapaz de tolerar la profilaxis para la tromboembolia con ácido acetilsalicílico, warfarina o heparina de bajo peso molecular, según indicación clínica.
    3) Hallazgos de la exploración física y de los análisis de laboratorio
    a) Calcio sérico corregido 14 mg/dl en el plazo de las 2 semanas previas a la aleatorización (a pesar de medidas adecuadas como un ciclo corto de corticosteroides, bisfosfonatos, hidratación, calcitonina).
    b) Recuento absoluto de neutrófilos < 1000 células/mm3. No se permiten los factores de crecimiento en el plazo de la semana anterior a la aleatorización.
    c) Plaquetas < 75.000 células/mm3 (75 × 109/L). El valor de laboratorio que cualifique para el estudio debe obtenerse en la medición más reciente antes de la aleatorización y nunca más de 14 días antes de la aleatorización. No se permiten transfusiones en el plazo de las 72 horas previas al valor de laboratorio que cualifique para el estudio.
    d) Hemoglobina < 8 g/dl. El valor de laboratorio que cualifique para el estudio debe obtenerse en la medición más reciente antes de la aleatorización y nunca más de 14 días antes de la aleatorización. No se permiten transfusiones en el plazo de las 72 horas previas al valor de laboratorio que cualifique para el estudio.
    e)Bilirrubina total 2 × límite superior de la normalidad (LSN) y bilirrubina directa 2,0 mg/dl.
    f)AST o ALT 3 × LSN.
    g)Aclaramiento de creatinina (CrCl) < 30 ml/min medido en orina de 24 horas o estimado mediante la fórmula de Cockcroft y Gault:
    4)Tratamiento o cirugía previos
    5)Alergias y reacciones adversas a medicamentos
    6)Sexo y estado reproductivo
    7)Otros criterios de exclusión
    Los criterios 4, 5, 6 y 7 no han sido desarrollados, véase la página 51 del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    En este estudio, el criterio principal de valoración es la supervivencia sin progresión (SSP), que se define como el tiempo desde la aleatorización a la fecha de la primera progresión documentada del tumor, en su determinación por el comité de revisión independiente utilizando los criterios del EBMT, o a la muerte. Los sujetos sin progresión de la enfermedad ni fallecimiento se censurarán en la fecha de su última evaluación de la enfermedad, siempre que no fallezcan más de 10 semanas después de la última evaluación del tumor
    The primary endpoint in this study is progression-free survival (PFS), which is defined as the time from randomization to the date of the first documented tumor progression, as determined by the IRC using EBMT criteria, or to death. Subjects who neither progress nor die will be censored on the date of their last disease assessment, provided death does not occur more than 10 weeks after the last tumor assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 4 weeks (-1/+3 days) relative to the first dose of study medication.
    Cada 4 semanas (-1/+3 dias) desde la primera dosis de medicacion del estudio
    E.5.2Secondary end point(s)
    Objective Response Rate - The percentage of patients who have a partial
    or complete response to study therapy.
    Overall Survival - The period of time from study entry until the date of
    death or last known date alive.
    Tasa de respuesta objetiva - Porcentaje de pacientes que tienen una respuesta parcial o completa a la terapia de estudio.
    Supervivencia global - El período de tiempo desde la entrada en el estudio hasta la fecha de fallecimiento o última fecha en que se contactara al paciente vivo
    E.5.2.1Timepoint(s) of evaluation of this end point
    All response endpoints assessed every 4 weeks (-1/+3 days).
    Survival will be assessed every 16 weeks in the Follow Up Phase of the
    trial.
    Todos los criterios de valoración de respuesta se evaluarán cada 4 semanas (-/+1 días).
    La supervivencia se evaluará cada 16 semanas en la fase de seguimiento del ensayo
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA103
    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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Poland
    Romania
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit of Last Subject
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months9
    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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 673
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 862
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug. Study drug will be provided via an extension of the study, a rollover study requiring
    approval by responsible health authority and ethics committee or through another mechanism at the discretion of the sponsor.
    A la conclusión del estudio, los sujetos que continúen demostrando un beneficio clínico serán elegibles para recibir el medicamento del estudio. El medicamento del estudio se proporcionará a través de una extensión del estudio, con un estudio de continuidad terapéutica (rollover) que requerirá la aprobación de las autoridades sanitarias y comités éticos responsables, o a través de otro mecanismo a criterio del promotor
    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 Decision2011-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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