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    Summary
    EudraCT Number:2015-004831-11
    Sponsor's Protocol Code Number:MEDI4736-MM-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 number2015-004831-11
    A.3Full title of the trial
    A Phase 1/2, multicenter, open-label study to determine the recommended dose and regimen of durvalumab (MEDI4736) in combination with lenalidomide (LEN) with and without dexamethasone (dex) in subjects with newly diagnosed multiple myeloma (NDMM).
    Estudio de fase 1/2, multicéntrico, abierto para determinar la dosis recomendada y la pauta posológica de durvalumab (MEDI4736) en combinación con lenalidomida (LEN), con o sin dexametasona (dex) en sujetos con mieloma múltiple de nuevo diagnóstico (MMND).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to decide what is the right dose of durvalumab to take in combination with lenalidomide with or without dexamethasone to treat a cancer of the bone marrow that is newly diagnosed.
    Un estudio para determinar la dosis recomendada de durvalumab en combinación con lenalidomida con o sin dexametasona en sujetos con cancer de médula ósea de nuevo diagnóstico.
    A.4.1Sponsor's protocol code numberMEDI4736-MM-002
    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 International II Sàrl
    B.1.3.4CountrySwitzerland
    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 International II Sàrl
    B.4.2CountrySwitzerland
    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 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34914229000
    B.5.5Fax number+1913266 0394
    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 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 namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 typeHumanised monoclonal antibody
    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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    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 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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 Dexamethasone tablets BP 2 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading 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.3.4Pharmaceutical 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 INNdexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE PH. EUR.
    D.3.9.4EV Substance CodeSUB170672
    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: 9
    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 Dexamethason-ratiopharm 4 mg tablets
    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.3.4Pharmaceutical 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 INNdexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE PH. EUR.
    D.3.9.4EV Substance CodeSUB170672
    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 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
    Newly diagnosed multiple myeloma
    Mieloma múltiple de nuevo diagnóstico
    E.1.1.1Medical condition in easily understood language
    Cancer of the bone marrow
    Cáncer de médula ósea
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the recommended dose of durvalumab in combination with LEN +/- dex in subjects with NDMM.
    Determinar la dosis recomendada de durvalumab en combinación con LEN con o sin dex en sujetos con MMND.
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and preliminary efficacy of durvalumab in combination with LEN +/- dex in subjects with NDMM
    - Evaluate the pharmacokinetics of durvalumab and LEN with and without dex in subjects with NDMM.
    -Evaluar la seguridad y la eficacia preliminar de durvalumab en combinación con LEN con o sin dex en sujetos con MMND.
    -Evaluar la farmacocinética de durvalumab y LEN con o sin dex en sujetos con MMND.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is ? 18 years of age at the time of signing the informed consent form (ICF)

    2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted

    3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements

    4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first ASCT are allowed), symptomatic multiple myeloma (MM) as defined in the protocol

    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

    6. Females of childbearing potential (FCBP) must:
    a. Have two negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
    b. She must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and be source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for 90 days after discontinuation of study treatment.
    c. Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab.

    7. Male subjects must :
    a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy.
    b. Refrain from sperm and blood donation for at least 90 days after the final dose of durvalumab

    8. For Cohort A subject must be transplant non-eligible (TNE) and meet at least one of the following high risk factors:
    a. Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q rearrangement; and / or t(14:16);or
    b. ISS Stage III; or
    c. Serum LDH > 2 x ULN

    9. For Cohort B subject must be ? 65 years of age at the time of signing the informed consent form (ICF) and transplant non-eligible (TNE); excluding the subjects who meet the Cohort A criteria

    10. For Cohort C subject must be after first autologous stem cell transplantation (ASCT) for NDMM and meet the following criteria:
    a. Have a post-transplant response as PR or better at the time of enrollment to this study;
    b. Have one of the following high risk factors at the time of NDMM diagnosis:
    - Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and/ or del(17p); and / or 1q rearrangement; and / or t(14; 16); or
    - ISS stage III; or
    - Serum LDH > 2 x ULN;
    c. MRD positive (defined as more than 1 malignant cell in 10^5 cells) measured by ClonoSIGHT? NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT? NGS assay
    1. El sujeto tiene ? 18 años de edad en el momento de firmar el formulario de consentimiento informado (FCI).

    2. El paciente debe entender y firmar de forma voluntaria un FCI antes de que se realice cualquier evaluación/procedimiento relacionado con el estudio.

    3. El sujeto está dispuesto y es capaz de cumplir el esquema de visitas del estudio y cualquier otro requisito del protocolo.

    4. El paciente presenta un diagnóstico documentado con MM sintomático sin tratamiento previo (para la cohorte C, se permite la terapia de inducción y consolidación junto con el primer TASPE), conforme a lo definido en el protocolo

    5. Estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2

    6. Las mujeres con capacidad de gestación (MCG ) deben:
    a. Presentar 2 pruebas de embarazo con resultado negativo, según lo verificado por el investigador antes del inicio del tratamiento del estudio. La paciente debe aceptar someterse a la prueba de embarazo durante el transcurso del estudio y tras el final del tratamiento del estudio. Esto se aplica incluso si la paciente practica abstinencia real del contacto heterosexual.
    b. Practicar la abstinencia real del contacto heterosexual (que debe revisarse mensualmente y documentarse con fuentes originales) o aceptar usar, y ser capaz de cumplir, métodos anticonceptivos eficaces sin interrupción, 28 días antes de iniciar el tratamiento del estudio, durante el mismo (incluidas las interrupciones de la dosis) y en los 90 días después de la suspensión del tratamiento del estudio.
    c. Abstenerse de realizar donación de óvulos y de sangre durante los 90 días posteriores a la administración de la última dosis de durvalumab.

    7. Los sujetos varones deben:
    a. Practicar la abstinencia real (que debe revisarse mensualmente) y aceptar usar un preservativo durante el contacto sexual con una mujer embarazada o con una MEF mientras esté participando en el estudio, durante las interrupciones de la dosis y durante, al menos, 90 días después de la suspensión del tratamiento del estudio, incluso si se ha sometido a una vasectomía satisfactoria.
    b. Abstenerse de donar semen y sangre durante, al menos, 90 días después de recibir la última dosis de durvalumab.

    8. Los sujetos de la cohorte A no deben ser elegibles para trasplante (NET) y es preciso que cumplan, al menos, uno de los siguientes factores de riesgo:
    a. Hallazgos de anomalías citogenéticas en clon de mieloma maligno con t(4; 14); y/o del(17p); y/o reordenación de 1q; y/o t(14:16); o
    b. Estadio III según ISS o
    c. LDH en suero > 2 x LSN

    9. Los sujetos de la cohorte B deben tener ? 65 años de edad en el momento de la firma del formulario del consentimiento informado (FCI) y no ser elegibles para trasplante (NET); se excluyen los pacientes que cumplen los criterios de la cohorte A

    10. Los sujetos de la cohorte C deben haberse sometido a trasplante autólogo de células madre (TACM) para MMND y cumplir los siguientes criterios:
    a. Presentar una respuesta posterior al trasplante que sea RP o mejor en el momento de la inclusión en el estudio;
    b. Disponer de uno de los siguientes factores de alto riesgo en el momento de MMND;
    ? Hallazgos de anomalías citogenéticas en clon de mieloma maligno con t(4; 14); y/o del(17p); y/o reordenación de 1q; y/o t(14; 16); o
    ? Estadio III según ISS o
    ? LDH en suero > 2 x LSN;
    c. Enfermedad mínima residual (EMR) Positiva(se define como más de 1 célula maligna en 105 células) estimada mediante el análisis de la SNG de una muestra de AMO con ClonoSIGHT?) en el momento de la inclusión en este estudio; muestra de AMO obtenida en el momento del diagnóstico de mieloma múltiple, antes de la terapia de inducción disponible para la evaluación de la EMR central mediante análisis de SNG con ClonoSIGHT?
    E.4Principal exclusion criteria
    1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1], for Cohort C, the induction and consolidation treatment along with the first ASCT are allowed)

    2. Any of the following laboratory abnormalities:
    a. Absolute neutrophil count (ANC) < 1,000/?L
    b. Untransfused platelet count < 75,000 cells/?L
    c. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 2.5 × upper limit of normal (ULN)
    d. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert?s syndrome
    e. Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L)

    3. Renal failure requiring hemodialysis or peritoneal dialysis

    4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment

    5. Peripheral neuropathy ? Grade 2

    6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis

    7. 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:
    a. Basal cell carcinoma of the skin
    b. Squamous cell carcinoma of the skin
    c. Carcinoma in situ of the cervix
    d. Carcinoma in situ of the breast
    e. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative

    8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C

    9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines

    10. Subjects had history of organ or allogeneic stem cell transplantation

    11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia

    12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone

    13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment

    14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment

    15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment

    16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. Exceptions to this criterion are detailed in the protocol

    17. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. Exceptions to this criterion are detailed in the protocol

    18. History of primary immunodeficiency

    19. Subject has incidence of gastrointestinal disease that may significantly alter the absorption of LEN

    20. Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab

    21. Unable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE)

    22. Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study

    23. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

    24. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

    25. Any condition that confounds the ability to interpret data from the study
    1. Administración previa de un tratamiento antimieloma (no incluye radioterapia, bisfosfonatos o un único ciclo corto de corticoesteroides [es decir, menor que o igual al equivalente de 40 mg/día de dexametasona durante 4 días; dicho ciclo corto de corticoesteroides no debe haberse administrado en los 14 díasprevios al Ciclo 1 Día 1], para la cohorte C, se permiten el tratamiento de inducción y consolidación junto con el primer TACM)
    2. Cualquiera de las siguientes anomalías de laboratorio:
    a.Recuento absoluto de neutrófilos (RAN) < 1.000/µl
    b.Número de plaquetas no transfundidas < 75.000 células/ µl
    c.Aspartato aminotransferasa en suero/transaminasa glutámico-oxalacética sérica (SGOT/AST) o alanina aminotransferasa (SGPT/ALT) > 3,0 × límite superior del valor normal (LSN)
    d.Bilirrubina total en suero > 1,5 × LSN o > 3,0 mg/dl para los sujetos con síndrome de Gilbert documentado
    e.Calcio corregido en suero >13.5 mg/dL (> 3.4 mmol/L)
    3. Insuficiencia renal que requiere hemodiálisis o diálisis peritoneal
    4. Cualquier afección médica grave que pone al sujeto en riesgo inaceptable si participa en el estudio. Ejemplos de dicha condición médica son, aunque no se limitan a, pacientes con cardiopatía inestable, que se define por: acontecimientos cardiacos como infarto de miocardio (IM) en los últimos 6 meses, insuficiencia cardiaca de clase III-IV según NYHA (New York Heart Association), hipertensión o fibrilación auricular no controlada; sujetos con afecciones que requieren la administración crónica de corticoesteroides o un tratamiento inmunosupresor, como artritis reumatoide, esclerosis múltiple y lupus, que es probable que precisen una terapia inmunosupresora o con corticoesteroides adicional al tratamiento del estudio
    5. Neuropatía periférica de grado ? 2
    6. Amiloidosis AL primaria (cadena ligera de inmunoglobulina) y mieloma con complicaciones por amiloidosis
    7. Antecedentes de neoplasias malignas, diferentes de MM, a menos que el sujeto haya estado libre de la enfermedad durante ? 5 años a excepción de las siguientes neoplasias malignas no invasivas:
    a.Carcinoma cutáneo de células basales
    b.Carcinoma cutáneo de células escamosas
    c.Carcinoma in situ de cuello uterino
    d.Carcinoma in situ de mama
    e.Hallazgo histológico accidental de cáncer de próstata (T1a o T1b utilizando el sistema de estadificación clínica TNM [tumor, ganglios, metástasis]) o cáncer de próstata curable
    8. El sujeto presenta un resultado positivo para el virus de la inmunodeficiencia humana (VIH); hepatitis B crónica o activa o hepatitis A o C activa
    9. El paciente se ha sometido a exposición previa a inmunoterapia, que incluye, pero no se limita a, inhibidor o anticuerpo monoclonal anti-PD-L1, anti-PD-1, anti-CTLA-4, tratamientos celulares o vacunas contra el cáncer
    10. El sujeto tiene antecedentes de trasplante orgánico o alogénico de progenitores hematopoyéticos
    11. El paciente ha presentado una evidencia clínica de leucostasis del sistema nervioso central (SNC) o leucostasis pulmonar, coagulación intravascular diseminada, mieloma múltiple del SNC o leucemia celular plasmática
    12. Conocimiento o sospecha de hipersensibilidad a los excipientes de la formulación de durvalumab, lenalidomida o dexametasona
    13. Cirugía mayor (según la definición del investigador) en los 28 días previos a la primera dosis del tratamiento del estudio
    14. Recepción de un tratamiento previo (por cualquier motivo) con un anticuerpo monoclonal en las 5 semividas del inicio del tratamiento del estudio
    15. Uso de cualquier agente en investigación en los 28 días o 5 vidas medias (lo que sea más largo) del inicio del tratamiento del estudio
    16. Uso actual o previo de una terapia inmunosupresora en los 14 días previos a la primera dosis del tratamiento del estudio. Las excepciones se describen en el protocolo
    17. Trastornos inflamatorios o autoinmunitarios en los últimos 3 años antes del inicio del tratamiento. Las excepciones se describen en el protocolo
    18. Antecedentes de inmunodeficiencia primaria
    19. El paciente presenta incidencia de enfermedad gastrointestinal que puede alterar significativamente la absorción de LEN
    20. Recepción de vacunas vivas atenuadas en los 30 días anteriores a la primera dosis de durvalumab
    21. El sujeto es incapaz o no está dispuesto a someterse a profilaxis para el tromboembolismo requerida por protocolo (para la cohorte C, esto solo se aplica a pacientes con antecedentes de TEV)
    22. Mujeres embarazadas, en periodo de lactancia o que planean quedarse embarazadas durante su participación en el estudio
    23. Cualquier afección médica significativa, anomalía de laboratorio o enfermedad psiquiátrica que evita que el sujeto participe en el estudio
    24. Cualquier afección, incluyendo la presencia de anomalías de laboratorio, que pone al paciente en un riesgo inaceptable si fuera a participar en el estudio
    25. Cualquier afección que confunde la capacidad de interpretar los datos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Review safety (including dose-limiting toxicities [DLTs]), and if applicable, PK/Pd, and/or biomarker, and/or preliminary efficacy data by Dose Review Team (DRT)
    Revisión de seguridad (incluyendo toxicidades limitantes de la dosis [TLDs]), y si aplica, FC/FD y/o biomarcadores, y/o los datos preliminares de eficacia por parte del equipo de revisión de la dosis (ERD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: 28 (+3) days after the EOT visit and 90 (+3) days after the last dose of durvalumab

    Efficacy: Day 1 of each cycle, and at End of Treatment

    The PK sampling time points will be as follows:
    - C1D1: preinfusion (-30 to -5 minutes prior to dose), end of infusion (EOI) (± 5 minutes), 4 hours (± 1 hour), 168 hours (C1D8) (± 2 hour), 336 hours (C1D15) (± 2 hour) and 504 hours (C1D22) (± 2 hour) after administration of durvalumab
    - C2D1: preinfusion (-30 to -5 minutes prior to dose), EOI (± 5 minutes), 4 hours (± 1 hour), and 336 hours (C2D15) (± 2 hour) after administration of durvalumab
    - C4D1, C6D1, C10D1, and C14D1: preinfusion (-30 to -5 minutes prior to dose)

    Biomarkers will be assessed at different time points, as applicable.
    Seguridad: 28 (+3) días después de la visita Final de Tratamiento y 90 (+3) días después de la última dosis de durvalumab
    Eficacia: Día 1 de cada ciclo, y al Final del Tratamiento
    Puntos de tiempo muestreo FC:
    - C1D1: preinfusión (-30 a -5 minutos antes de la dosis), final de la infusión (FDI) (± 5 minutos), 4 horas (± 1 hora), 168 horas (C1D8) (± 2 horas), 336 horas (C1D15) (± 2 horas) y 504 horas (C1D22) (± 2 horas) después de la administración de durvalumab
    - C2D1: preinfusión (-30 a -5 minutos antes de la dosis), FDI (± 5 minutos), 4 horas (± 1 hora), y 336 horas (C2D15) (± 2 horas) después de la administración de durvalumab
    - C4D1, C6D1, C10D1 y C14D1: preinfusión (-30 a -5 minutos antes de la dosis)
    biomarcadores se evaluarán en diferentes momentos, según corresponda
    E.5.2Secondary end point(s)
    Safety - Type, frequency, seriousness and severity of adverse events (AEs) (included second primary malignancies), and relationship of AEs to study treatment

    Overall Response Rate (ORR) (for Cohorts A and B) - Tumor response, including progressive disease, based on the investigator assessments according to the International Myeloma Working Group (IMWG) Uniform Response Criteria

    Response Improvement Rate (RIR) (for Cohort C) - Response improved from the assessment at the Cycle 1 Day 1 (C1D1); (Pre-autologous stem cell transplantation [ASCT] diseases measurement will be used as baseline for response assessment)

    Time to Response (TTR) (for Cohorts A and B) - Time from C1D1to the first documentation of response

    Duration of response (DOR) (for Cohorts A and B) - Time from the first response (partial response [PR] or better) to the first documentation of disease progression or death, whichever is earlier, based on the investigator assessments according to the IMWG Uniform Response Criteria

    Pharmacokinetic - Typical serum/plasma PK parameters for durvalumab and lenalidomide, such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal elimination half-life (t1/2), clearance (CL/F), and volume of distribution (Vz/F)

    Immunogenicity - Frequency of development of anti-drug antibodies and neutralization

    Progression-Free Survival (PFS) - Time from C1D1 to the first documentation of disease progression (based on the investigator assessments according to the IMWG Uniform Response Criteria) or death from any cause during study, whichever occurs earlier

    Overall Survival (OS) - Time from C1D1 to death due to any cause
    Seguridad - Tipo, frecuencia, severidad y gravedad de los acontecimientos adversos (AEs) (incluidos las segundas neoplasias malignas primarias), y la relación de los AEs con el tratamiento del estudio
    Tasa global de respuesta (ORR) (para las cohortes A y B) - La respuesta del tumor, incluyendo la enfermedad progresiva, en base a las evaluaciones del investigador de acuerdo con los Criterios de Respuesta Uniforme del International Myeloma Working Group (IMWG)
    Tasa de respuesta de Mejora (RIR) (para la cohorte C) - Respuesta mejorada de la evaluación en el ciclo 1 Día 1 (C1D1); (se utilizara la medición de enfermedades de trasplante pre-autólogo de células madre [ASCT] como base de referencia para evaluación de la respuesta)
    Tiempo de respuesta (TTR) (para las cohortes A y B) - Tiempo de C1D1 hasta la primera documentación de la respuesta
    Duración de la respuesta (DOR) (para las cohortes A y B) - Tiempo desde la primera respuesta (respuesta parcial [PR] o mejor) a la primera documentación de progresión de la enfermedad o la muerte, lo que ocurra primero, basado en las evaluaciones del investigador de acuerdo con los Criterios de Respuesta Uniforme del IMWG
    Farmacocinética - Parámetros FC típicos en suero/plasma para durvalumab y lenalidomida, tales como la concentración máxima observada (Cmax), área bajo curva de concentración-tiempo (AUC), el tiempo hasta la concentración máxima (Tmáx), la vida media de eliminación terminal (t1 / 2 ), el aclaramiento (CL / F), y el volumen de distribución (Vz / F)
    Inmunogenicidad - Frecuencia de desarrollo de anticuerpos anti-drogas y neutralización
    Supervivencia libre de progresión (SLP) - Tiempo de C1D1 a la primera documentación de progresión de la enfermedad (en base a las evaluaciones del investigador de acuerdo con los Criterios de Respuesta Uniforme IMWG) o muerte por cualquier causa durante el estudio, lo que ocurra antes
    La Supervivencia Global (SG) - Tiempo de C1D1 hasta la muerte por cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: 28 (+3) days after the EOT visit and 90 (+3) days after the last dose of durvalumab

    Efficacy: Day 1 of each cycle, and at End of Treatment

    The PK sampling time points will be as follows:
    - C1D1: preinfusion (-30 to -5 minutes prior to dose), end of infusion (EOI) (± 5 minutes), 4 hours (± 1 hour), 168 hours (C1D8) (± 2 hour), 336 hours (C1D15) (± 2 hour) and 504 hours (C1D22) (± 2 hour) after administration of durvalumab
    - C2D1: preinfusion (-30 to -5 minutes prior to dose), EOI (± 5 minutes), 4 hours (± 1 hour), and 336 hours (C2D15) (± 2 hour) after administration of durvalumab
    - C4D1, C6D1, C10D1, and C14D1: preinfusion (-30 to -5 minutes prior to dose)

    Biomarkers will be assessed at different time points, as applicable.
    Seguridad: 28 (+3) días después de la visita Final de Tratamiento y 90 (+3) días después de la última dosis de durvalumab
    Eficacia: Día 1 de cada ciclo, y al final del tratamiento
    Puntos tiempo muestreo FC:
    - C1D1: preinfusión (-30 a -5 minutos antes de la dosis), final de la infusión (FDI) (± 5 minutos), 4 horas (± 1 hora), 168 horas (C1D8) (± 2 horas), 336 horas (C1D15) (± 2 horas) y 504 horas (C1D22) (± 2 horas) después de la administración de durvalumab
    - C2D1: preinfusión (-30 a -5 minutos antes de la dosis), FDI (± 5 minutos), 4 horas (± 1 hora), y 336 horas (C2D15) (± 2 horas) después de la administración de durvalumab
    - C4D1, C6D1, C10D1 y C14D1: preinfusión (-30 a -5 minutos antes de la dosis)
    Los biomarcadores serán evaluados en diferentes momentos, según corresponda.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding
    búsqueda de dosis
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    durvalumab en combinación con lenalidomida con y sin dexametasona
    durvalumab in combination with lenalidomide with and without dexamethasone
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Canada
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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 post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for the primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    El final del ensayo se define bien como la fecha de la última visita del último sujeto que complete el seguimiento posterior al tratamiento o bien como la fecha de recepción del último dato del último sujeto que sea necesario para el análisis principal, secundario y/o exploratorio, tal y como se ha especificado previamente en el protocolo, la que sea más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 138
    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)
    All subjects may continue to receive study treatment until disease progression or unacceptable toxicity, or until withdrawal of consent. Subjects are to return to the study site 28 (+3) days after the EOT visit and 90 (+3) days after the last dose of durvalumab for safety follow-up visits procedures.
    Todos los sujetos pueden continuar recibiendo el tratamiento del estudio hasta progresión de la enfermedad o toxicidad inaceptable o retirada del consentimiento. Los sujetos deberán volver al centro del estudio a los 28 (+ 3) días después de la visita de Final de Tratamiento y a los 90 (+ 3) días tras la última dosis de durvalumab para realizar las visitas de seguimiento de la seguridad.
    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 Decision2016-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-02
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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