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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44044   clinical trials with a EudraCT protocol, of which   7319   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2016-001209-17
    Sponsor's Protocol Code Number:MEDI4736-MM-003
    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:2016-07-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-001209-17
    A.3Full title of the trial
    A PHASE 2, MULTICENTER, OPEN-LABEL, STUDY TO DETERMINE THE SAFETY AND EFFICACY FOR THE COMBINATION OF DURVALUMAB (DURVA) AND DARATUMUMAB (DARA) (D2) IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (FUSION MM-003)
    “Estudio de fase II multicéntrico abierto para determinar la seguridad y la eficacia de la combinación de durvalumab (DURVA) y daratumumab (DARA) (D2) en sujetos con mieloma múltiple recidivante y resistente al tratamiento (MMRR) (FUSION MM-003)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety and efficacy for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma.
    Un estudio para determinar la seguridad y eficacia de la combinación de durvalumab y daratumumab (D2) para tratar mieloma múltiple recidivante y resistente
    A.3.2Name or abbreviated title of the trial where available
    FUSION MM-003
    FUSION MM-003
    A.4.1Sponsor's protocol code numberMEDI4736-MM-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02807454
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1184-5484
    A.5.4Other Identifiers
    Name:INDNumber:127058
    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+1888260 1599
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed 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 No
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product namedaratumumab
    D.3.2Product code JNJ-54767414
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeHumanised monoclonal antibody
    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 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.3.1Product nameDexamethasone
    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: 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 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.3.1Product nameDexamethasone
    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.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 Dexamethasone CF 20 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.4Pharmaceutical form 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 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/ml milligram(s)/millilitre
    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: 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 Imnovid 1 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.2Product code CC-4047
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Imnovid 2 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.2Product code CC-4047
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Imnovid 3 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.2Product code CC-4047
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Imnovid 4 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.2Product code CC-4047
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Relapsed and refractory multiple myeloma
    mieloma múltiple recidivante y resistente
    E.1.1.1Medical condition in easily understood language
    Cancer of the bone marrowof that has recurred or no longer responds to current treatment
    Cáncer de médula ósea recurrente o que ya no responde al tratamiento actual
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and efficacy of DURVA and DARA in subjects with RRMM
    Determinar la seguridad y la eficacia de DURVA y DARA en sujetos con MMRR.
    E.2.2Secondary objectives of the trial
    - Evaluate additional measures of efficacy (time-to-response, duration of response, progressive-free survival) of DURVA and DARA in subjects with RRMM;
    - Evaluate the pharmacokinetics (PK) of DURVA and DARA in subjects with RRMM.
    Evaluar medidas adicionales de eficacia (tiempo hasta la respuesta, duración de la respuesta, supervivencia sin progresión) de D2 en sujetos con MMRR
    Evaluar la farmacocinética (FC) de DURVA y DARA en sujetos con MMRR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject received at least 3 prior anti-myeloma regimen including a PI and an immunomodulatory agent or is double-refractory to a PI and an immunomodulatory agent.
    · Induction, bone marrow transplant with or without maintenance therapy is considered one regimen.
    · Refractory is defined as disease that is nonresponsive on therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy.
    · For subjects who received more than 1 regimen containing a PI their disease must be refractory to the most recent PI containing regimen.
    · For subjects who received more than 1 regimen containing a immunomodulatory agent their disease must be refractory to the most recent immunomodulatory agent containing regimen.

    2. Subject has measurable disease defined as:
    a. M-protein (serum protein electrophoresis (sPEP) or urine protein electrophoresis (uPEP): sPEP ≥ 0.5 g/dL or uPEP ≥ 200 mg/24 hours) and/or
    b. Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.

    3. Subject achieved a response (MR or better) to at least 1 prior treatment regimen.

    4. Subject has evidence of PD on or within 60 days of the most recent prior treatment regimen.

    5. Subject received an alkylating agent alone or in combination with other myeloma treatment.

    6. Subject has an Eastern Cooperative Oncology Group performance-status score of 2 or less.

    7. Subject’s toxicities resulting from previous therapy (including peripheral neuropathy) have resolved or stabilized to ≤ Grade 1.

    8. Subject is at least 18 years of age at the time of signing the informed consent form (ICF).

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

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

    11. Females of childbearing potential (FCBP ) must:
    a. Have 2 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. Either practice true abstinence2 from heterosexual contact (which must be reviewed on a monthly basis and 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 at least 90 days after discontinuation of study treatment.
    c. Refrain from egg cell donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.

    12. Male subjects must:
    a. Either 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 female of childbearing potential 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 donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.
    1. El sujeto debe haber recibido al menos 3 pautas posológicas previas para el mieloma con un IP y un inmunomodulador o debe presentar doble resistencia a un IP y a un inmunomodulador.
    • La inducción, los trasplantes de médula ósea con o sin tratamiento de mantenimiento se consideran una pauta posológica.
    • Se define como resistente al tratamiento aquella enfermedad que no responde al tratamiento o que progresa en los 60 días siguientes al último tratamiento. La enfermedad que no responde se define como, o bien la imposibilidad de conseguir una respuesta mínima o bien el desarrollo de progresión de la enfermedad durante el tratamiento.
    • En el caso de los sujetos que hayan recibido más de 1 pauta posológica con un IP, su enfermedad debe ser resistente a la pauta posológica con IP más reciente.
    • En el caso de los sujetos que hayan recibido más de 1 pauta posológica con un inmunomodulador, su enfermedad debe ser resistente a la pauta posológica con inmunomodulador más reciente.
    2. El sujeto debe presentar enfermedad cuantificable definida como:
    a. Proteína M (electroforesis de proteínas en suero o en orina [EFPs o EFPo]: EFPs ≥ 0,5 g/dl o EFPo ≥ 200 mg/24 horas) y/o
    b. MM de cadena ligera sin enfermedad evaluable en suero o en orina: cadena ligera libre de inmunoglobulina en suero ≥ 10 mg/dl y proporción anómala de cadenas ligeras libres de inmunoglobulina κ λ en suero
    3. El sujeto consiguió una respuesta (RM o mejor) al menos a 1 pauta posológica previa de tratamiento.
    4. El sujeto tiene indicios de PE estando en tratamiento o en los 60 días previos a la pauta posológica previa más reciente.
    5. El sujeto ha recibido un alquilante en monoterapia o en combinación con otro tratamiento para el mieloma.
    6. El sujeto tiene una puntuación de 2 o menos del estado funcional del Grupo Oncológico Cooperativo del Este (ECOG).
    7. Las toxicidades del sujeto que se han provocado por un tratamiento anterior (incluida la neuropatía periférica) se han resuelto o estabilizado en ≤ grado 1.
    8. El sujeto tiene al menos 18 años de edad en el momento de la firma del formulario de consentimiento informado (FCI).
    9. El sujeto debe comprender y firmar de forma voluntaria un FCI antes de que se realice cualquier evaluación/procedimiento relacionado con el estudio.
    10. El sujeto está dispuesto y es capaz de cumplir el calendario de visitas del estudio y otros requisitos del protocolo.
    11. Las mujeres en edad fértil (MEF) deben:
    a. Presenta 2 pruebas de embarazo negativas verificadas por el investigador antes de comenzar con el tratamiento del estudio. Debe aceptar someterse a pruebas de embarazo de forma regular durante el transcurso del estudio y después del final del tratamiento del estudio. Esto se aplica aunque la paciente practique una abstinencia total del contacto heterosexual.
    b. Debe practicar bien una abstinencia total del contacto heterosexual (que se debe revisar de forma mensual y documentarse en los originales) o bien aceptar el uso y ser capaz de cumplir con un método anticonceptivo eficaz sin interrupción, 28 días antes del inicio del tratamiento del estudio, durante el tratamiento del estudio (incluidas las interrupciones de la dosis) y durante al menos 90 días tras la suspensión definitiva del tratamiento del estudio.
    c. Abstenerse de donar óvulos como mínimo durante los 90 días posteriores a la dosis final de DURVA o de DARA, lo que suceda más tarde.
    12. Los sujetos hombres deben:
    a. Bien practicar la abstinencia total2 (que se debe revisar de forma mensual) o bien aceptar el uso de preservativo durante el contacto sexual con mujeres embarazadas o en edad fértil mientras participe en el estudio, durante las interrupciones de la dosis y durante al menos 90 días tras la suspensión definitiva del tratamiento del estudio, aunque se haya sometido con éxito a una vasectomía.
    b. Abstenerse de donar semen como mínimo durante los 90 días posteriores a la dosis final de DURVA o de DARA, lo que suceda más tarde.
    E.4Principal exclusion criteria
    1. Subject has had prior exposure to anti-CTLA-4, anti-PD-1, anti-PD-L1 mAbs, cell-based therapies, or cancer vaccines
    2. Subject received DARA or other anti-CD38 therapies previously
    3. Subject received any of the following within the last 14 days of initiating study treatment:
    a. Plasmapheresis
    b. Major surgery (as defined by the investigator)
    c. Radiation therapy other than local therapy for myeloma associated bone lesions
    c. Use of any systemic anti-myeloma drug therapy
    4. Subject received prior treatment with a monoclonal antibody within 5 half-lives of initiating study treatment
    5. Subject used any investigational agents within 28 days or 5 half-lives of initiating study treatment
    6. Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment
    7. History of organ or allogeneic stem cell transplantation
    8. Subject has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization
    9. Subject has any of the following laboratory abnormalities:
    a. Absolute neutrophil count (ANC) < 1,000/μL
    b. Platelet count: < 75,000/μL (it is not permissible to transfuse a subject to reach this level)
    c. Hemoglobin < 8 g/dL (< 4.9 mmol/L)(it is not permissible to transfuse a subject to reach this level)
    d. Creatinine Clearance (CrCl) < 45 mL/min
    e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
    f. Serum aspartate aminotransferase (AST) or alanine aminotransferase(ALT) > 2.5 × upper limit of normal (ULN)
    g. Serum total bilirubin > 1.5 × upper limit of normal (ULN) or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome
    10. Subject has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS MM
    11. Subject has known COPD with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
    12. Subject has known moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification
    13. Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis
    14. Subject has nonsecretory MM
    15. Subject has known allergy or hypersensitivity to study drug formulations
    16. Subject has active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
    a. Subjects with vitiligo or alopecia.
    b. Subjects with hypothyroidism stable on hormone replacement.
    c. Psoriasis not requiring systemic treatment.
    17. Subject has history of primary immunodeficiency
    18. Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
    19. Subject has received live, attenuated vaccine within 30 days prior to the first dose of DURVA
    20. Subject is currently using or has used immunosuppressive medication within 14 days prior to the first study dose of study treatment. The following are exceptions to this criterion:
    a. Intranasal, inhaled, or local steroid injections
    b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
    c. Steroids as premedication for hypersensitivity reactions
    21. Subject has any one of the following:
    a. Clinically significant abnormal ECG finding at screening
    b. Congestive heart failure
    c. Myocardial infarction within 12 months prior to starting study treatment
    d. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
    22. Subject has 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 noninvasive 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 or prostate cancer that is curative
    23. Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study
    24. Subject has significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    25. Subject has a condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    26. Subject has a condition that confounds the ability to interpret data from the study
    For subjects who will have POM+dex added to the D2 and enrolled into the PD3 cohort:
    27. Subject has history of anaphylaxis or hypersensitivity to thalidomide, LEN, POM, or dex
    28. Subject has history of rash ≥ Grade 3 during prior thalidomide, LEN, or POM therapy
    29. Subject has known or suspected hypersensitivity to the excipients contained in the formulation of POM or dex.
    30. Subject is a current smoker
    1.El sujeto tuvo exposición previa a anticuerpos contra CTLA-4, anticuerpos contra PD-1, Acm contra PD-L1, tratamientos celulares (p. ej., tratamiento CAR con linfocitos T) o vacunas contra el cáncer. 2.El sujeto recibió previamente DARA u otros anti-CD38.3.El sujeto recibió alguno de los siguientes tratamientos 14 días previos al tratamiento: a.Plasmaféresis b.Cirugía mayor c.Radioterapia, aparte del tratamiento local para las lesiones óseas asociadas al mieloma.c.Uso de cualquier farmacoterapia sistémica para el mieloma 4.El sujeto ha recibido tratamiento previo con un anticuerpo monoclonal durante las 5 semividas previas al tratamiento del estudio.5.El sujeto ha usado algún producto en investigación durante los 28 días o 5 semividas anteriores al inicio del tratamiento del estudio.6.El sujeto está recibiendo simultáneamente quimioterapia o algún tratamiento biológico u hormonal para el cáncer.7.Antecedentes de trasplante de órganos o de alotrasplante de células madre hematopoyéticas.8.El sujeto ha recibido un ATCM en las 12 semanas anteriores a la fecha de la aleatorización.9.El sujeto tiene cualquiera de las siguientes anomalías analíticas: a.RAN < 1000/µl.b.Recuento de plaquetas: < 75 000/µl.c.Hemoglobina < 8 g/dl (< 4,9 mmol/l) (no se permite transfundir).d.(AcCr) < 45 ml/min.e.Calcio sérico corregido > 13,5 mg/dl (> 3,4 mmol/l).f. (AST) sérica o (ALT) sérica > 2,5 ×LSN.g.Bilirrubina sérica total > 1,5 ×LSN o > 3,0 mg/dl en los sujetos con síndrome de Gilbert documentado. 10.El sujeto tiene muestras clínicas de leucostasis del (SNC) o pulmonar, de coagulación intravascular diseminada o de MM en el SNC.11.El sujeto tiene (EPOC)conocida, con un volumen espiratorio forzado en 1 segundo(VEF1)del 50 % del valor normal previsto.12.El sujeto tiene asma conocida persistente moderada o intensa durante los 2 años anteriores (véase el apéndice F) o asma incontrolada de cualquier clase.13.El sujeto tiene leucemia plasmocítica, macroglobulinemia de Waldenström, síndrome POEMS o amiloidosis.14.El sujeto tiene MM no secretor.15.El sujeto tiene alergia o hipersensibilidad conocida a alguna de las formulaciones de los fármacos del estudio.16.El sujeto tiene trastornos autoinmunitarios o inflamatorios documentados activos o previos en los 3 años previos al tratamiento. Excepciones a este criterio:a.Sujetos con vitiligo o alopecia.b.Sujetos con hipotiroidismo (p. ej., tras sufrir síndrome de Hashimoto) estable con tratamiento restitutivo hormonal.c.Psoriasis que no necesite tratamiento sistémico. 17.El sujeto tiene antecedentes de inmunodeficiencia primaria.18.El sujeto da un resultado positivo para (VIH), hepatitis B crónica o activa, o hepatitis A o C activa.19.El sujeto ha recibido vacunación con agentes vivos atenuados en los 30 días anteriores a empezar DURVA.20.El sujeto está usando o usó inmunodepresores en los 14 días previos a la 1ª dosis del tratamiento del estudio. Excepciones a este criterio:a.Corticosteroides intranasales, inhalados o en inyección local.b.Corticosteroides sistémicos a dosis fisiológicas no superiores a 10 mg/día de prednisona o equivalente.c.Corticoides como medicación previa para las reacciones de hipersensibilidad.21.El sujeto tiene cualquiera de las siguientes afecciones:a.Hallazgos anómalos clínicamente significativos en el electrocardiograma (ECG) en la selección.b.Insuficiencia cardíaca congestiva (clase III o IV según la Asociación del Corazón de Nueva York [New York Heart Association])c.Infarto de miocardio en los 12 meses previos al tratamiento.d.Angina de pecho inestable o mal controlada, incluida la variante de angina de pecho de Prinzmetal.22.El sujeto tiene antecedentes de neoplasias malignas aparte del MM, salvo que haya permanecido exento de enfermedad durante ≥ 5 años, con excepción de las siguientes neoplasias malignas no invasivas:a.Carcinoma basocelular de la piel.b.Carcinoma epidermoide de la piel.c.Carcinoma in situ de cuello uterino.d.Carcinoma in situ de mama.e.Hallazgo histológico casual de cáncer de próstata o cáncer de próstata curable.23.La paciente es una mujer embarazada, en periodo de lactancia o que pretende quedarse embarazada durante su participación en el estudio.24.El sujeto tiene cualquier afección médica, anomalía analítica o enfermedad psiquiátrica importante que pueda impedir su participación en el estudio.25.El sujeto tiene cualquier afección, incluida la presencia de anomalías analíticas, que le expone a un riesgo inaceptable si participa en el estudio.26.El sujeto tiene cualquier afección que interfiere en la capacidad para interpretar los datos del estudio.27.El sujeto tiene antecedentes de anafilaxia o de hipersensibilidad a talidomida, LEN, POM o dex.28.El sujeto tiene antecedentes de erupción ≥ grado 3 durante un tratamiento previo con talidomida, LEN o POM.29.El sujeto tiene hipersensibilidad conocida o sospecha de hipersensibilidad a los excipientes que contiene la formulación de POM o dex.30.El sujeto es fumador en ese momento.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall response rate (ORR): tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria.

    - Safety: type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
    - Tasa de respuesta global (TRG): Respuesta tumoral, incluida la progresión de la enfermedad (PE) según los criterios uniformes de respuesta del Grupo Internacional de Trabajo sobre el Mieloma (IMWG).
    - Seguridad: Tipo, frecuencia, gravedad e intensidad de los acontecimientos adversos (AA) y relación de los AA con el tratamiento del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall response rate: Tumor response, including PD, will be assessed by the investigators using the IMWG criteria. The ORR will be calculated as the percent of responders (count of subjects with at least a PR, divided by the number of subjects in the EE Population). The ORR together with the proportions in each response category based on the IMWG criteria will be tabulated by dose cohort and arm. A 95% confidence interval of the ORR of D2 for all subjects treated with the RP2D and an 80% confidence interval of the ORR of exploratory PD3cohort will be provided.

    AEs: At screening and Continuously, until 90 days after last dose of DURVA or DARA, whichever is later
    La respuesta tumoral, incluida la PE, la evaluarán los investigadores mediante los criterios del Grupo Internacional de Trabajo sobre el Mieloma (IMWG).
    La TRG se calculará como el porcentaje de pacientes con respuesta (número de sujetos con al menos una RP, dividido por el número de sujetos de la población EvE). Se pondrá en tablas la TRG junto con las proporciones de cada categoría de respuesta con base en los criterios del IMWG. Se facilitarán el intervalo de confianza del 95 % de la TRG de D2 de todos los sujetos tratados con DRF2 y un intervalo de confianza del 80 % de la TRG de la cohorte exploratoria PD3.
    AA: En la selección y de forma continua , hasta 90 días después de la última dosis de DURVA o DARA lo que suceda más tarde
    E.5.2Secondary end point(s)
    - Time-to-response (TTR): time from enrollment to the first documentation of response (Partial Response [PR] or greater).

    - Duration of response (DOR): time from the first documentation of response (PR or greater) to the first documentation of PD.

    - Progression-free survival (PFS): time from enrollment to the first documentation of PD or death from any cause during study, whichever occurs earlier.

    PK parameters: Typical serum/plasma PK parameters for DURVA and DARA, 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).
    - Tiempo hasta la respuesta (ThR): Tiempo desde la inscripción hasta la primera documentación de la respuesta (respuesta parcial [RP] o superior).
    - Duración de la respuesta (DdR): Tiempo desde la primera documentación de respuesta (RP o superior) hasta la primera documentación de PE
    - Supervivencia sin progresión (SSP): Tiempo desde la inscripción hasta la primera documentación de PE o muerte por cualquier causa durante el estudio, lo que ocurra antes
    - Parámetros de FC: Parámetros FC habituales en suero/plasma de DURVA y DARA, como la concentración máxima observada (Cmáx), el área bajo la curva (ABC) de concentración-tiempo, el tiempo hasta la concentración máxima (Tmáx), la semivida de eliminación terminal (t1/2), el aclaramiento (Cl/F) y el volumen de distribución (Vz/F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The PK sampling time points for DURVA in Phase 2 Stage 1 will be as follows:
    • C1D2: predose (-30 to -5 minutes prior to dose), end of infusion (EOI) (+5 minutes),
    •C1D8: 144 hours post C1D2 dose (± 1 hour),
    • C1D15: 312 hours post C1D2 dose (± 1 hour),
    • C1D22: 480 hours post C1D2 dose (± 1 hour).
    • Additional Durvalumab PK samples to be collected to match immunogenicity collections predose on C2D1, C4D1, C6D1, C10D1, and C14D1.
    The PK sampling time points for DARA in Phase 2 Stage 1 will be as follows:
    • C1D1, C1D8, C1D15, C1D22: predose (-30 to -5 minutes prior to dose), and EOI (+5 minutes)
    • EOT,
    • 28 days after EOT,
    • 90 days after last DARA or DURVA dose.
    Suj inscritos etapa 1 fase II participarán en muestras FC durvalumab en puntos:D2C1: pre dosis(-30 a -5 min de dosis)y final de infusión(FdI)(+5 minutos),D8C1:144 horas post dosis del D2C1(± 1 hora),D15C1: 312 horas post dosis del D2C1 (± 1 hora),D22C1:480 horas post dosis del D2C1 (± 1 hora)Se obtendrán otras muestras FC durvalumab coincidentes con inmunogenia pre dosis D1C2, D1C4, D1C6, D1C10 y D1C14. Todos suj inscritos en etapa 1 fase II participarán en muestras FC daratumumab en puntos:D1C1: pre dosis(-30 a -5 min de dosis) y en FdI (+5 min),D8C1: pre dosis(-30 a -5 min antes de dosis)y en FdI(+5 min),D15C1: pre dosis(-30 a -5 min antes de dosis)y en FdI(+5 min)D22C1: pre dosis(-30 a -5 min pre dosis)y en FdI(+5 min),FdT,28 días post FdT,90 días post última dosis de DARA o DURVA.
    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
    tolerability
    Tolerabilidad
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Diseño 3+3 para confirmar la tolerabilidad de DURVA y DARA.
    3+3 design to confirm the tolerability for DURVA and DARA. Simon 2-stage design for Phase 2 portion
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    durvalumab en combinación con datatumumab con y sin
    durvalumab in combination with datatumumab with and without pomalidomide + dexamethasone
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    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 primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    El final del ensayo se define como la fecha de la última visita del último sujeto en completar el seguimiento posterior al tratamiento o bien como la fecha en la que se obtiene del último sujeto el último dato necesario para los análisis principal, secundario y/o exploratorio, lo que ocurra más tarde, tal y como se especifica previamente en el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 144
    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)
    None
    Ninguno
    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 Decision2016-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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