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    The EU Clinical Trials Register currently displays   44294   clinical trials with a EudraCT protocol, of which   7351   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).

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    Summary
    EudraCT Number:2018-004767-31
    Sponsor's Protocol Code Number:CC-92480-MM-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 number2018-004767-31
    A.3Full title of the trial
    A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination with Standard Treatments in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
    Estudio de fase I/II, abierto y multicéntrico para determinar la dosis y la pauta recomendadas y evaluar la seguridad y la eficacia preliminar del CC-92480 en combinación con tratamientos estándar en sujetos con mieloma múltiple en recaída o refractario (MMRR) y mieloma múltiple de nuevo diagnóstico (MMND)”.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to Determine the Recommended Dose, Dosing Pattern, Effectiveness and Safety of CC-92480 When Combined with Standard Treatments in Patients Who have Non-responsive or Recurrent Myeloma and in Patients Who Have Been Newly Diagnosed with Myeloma.
    Un estudio para determinar la dosis recomendada, el patrón de dosificación, la eficacia y la seguridad de CC-92480 cuando se combina con tratamientos estándar en pacientes con mieloma no sensible o recurrente y en pacientes con diagnóstico reciente de mieloma.
    A.4.1Sponsor's protocol code numberCC-92480-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 Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 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 nameCC-92480 0.1 mg
    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 INNCereblon-modifying (CM) agent
    D.3.9.1CAS number 2259648-80-9
    D.3.9.2Current sponsor codeCC-92480
    D.3.9.4EV Substance CodeSUB190554
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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: 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCC-92480 0.5 mg
    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 INNCereblon-modifying (CM) agent
    D.3.9.1CAS number 2259648-80-9
    D.3.9.2Current sponsor codeCC-92480
    D.3.9.4EV Substance CodeSUB190554
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 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 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 nameCC-92480 2 mg
    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 INNCereblon-modifying (CM) agent
    D.3.9.1CAS number 2259648-80-9
    D.3.9.2Current sponsor codeCC-92480
    D.3.9.4EV Substance CodeSUB190554
    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 VELCADE 3.5 mg powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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: 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 DARZALEX 20 mg/mL concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDARZALEX 20 mg/mL concentrate for solution for infusion.
    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.3.9.4EV 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: 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 Kyprolis 60 mg powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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/3/08/548
    D.3 Description of the IMP
    D.3.1Product namecarfilzomib
    D.3.4Pharmaceutical form Powder 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 INNCarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Dexamethasone 2mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Limited
    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 BP
    D.3.9.4EV Substance CodeSUB36974
    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 Dexamethasone Tablets BP 4.0mg
    D.2.1.1.2Name of the Marketing Authorisation holderJENAPHARM
    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 BP
    D.3.9.4EV Substance CodeSUB36974
    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: 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 Dexamethasone 20 mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    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
    D.3.9.4EV Substance CodeSUB36974
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM (NDMM)
    Mieloma múltiple recidivante o resistente al tratamiento (MMRR) y mieloma múltiple recién diagnosticado.
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed multiple myeloma and multiple myeloma that recurs or is resistant to other treatments previously tried by the patient.
    Mieloma múltiple de diagnóstico reciente y mieloma múltiple que recurre o es resistente a otros tratamientos previamente probados por el paciente.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10028229
    E.1.2Term Multiple myelomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the recommended dose and regimen, and evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments in subjects with RRMM and NDMM
    Determinar la dosis y la pauta recomendadas, y evaluar la seguridad y la eficacia preliminar del CC-92480 en combinación con tratamientos habituales en pacientes con MMRR y MMRD.
    E.2.2Secondary objectives of the trial
    Evaluate additional measures of efficacy (time-to-response, duration of response, complete response rate) of CC-92480 in combination with standard treatments in subjects with RRMM and NDMM
    Evaluar medidas adicionales de la eficacia (tiempo transcurrido hasta la respuesta, duración de la respuesta e índice de respuesta completa) del CC-92480 en combinación con tratamientos habituales en pacientes con MMRR y MMRD.
    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 has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
    5. Females of childbearing potential (FCBP) must:
    a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. 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 commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two reliable forms of contraception as defined in the Pregnancy Prevention Plan (PPP)without interruption, 28 days prior to starting CC-92480, during the study treatment (including during dose interruptions), and for 28 days after the last dose of CC-92480 or 90 days after the last dose of BTZ (for Cohorts A, D and G) or DARA (for Cohorts B and E) or 6 months after the last dose of CFZ (for Cohorts C and F), whichever is later.
    Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point and, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months.
    6. Male subjects must:
    a. Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose
    interruptions) and for at least 3 months following study treatment discontinuation, even if he has undergone a successful vasectomy.
    * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.
    7. Males must agree to refrain from donating sperm or semen while on study treatment, and for at least 3 months following last dose of study treatment. Females must refrain from egg cell (ova) donation while on study treatment, and for 28 days after the last dose of CC-92480.
    8. All subjects must agree to refrain from donating blood while on study treatment and for 28 days after the last dose of study treatment.
    9. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Plan for Subjects in Clinical Trials.

    Please refer to protocol for additional inclusion criteria for subjects in Cohorts A, B, C, D, E and F and for subjects in Cohort G.
    1. Tener ≥18 años en el momento de firmar el documento de consentimiento informado (DCI).

    2. Comprender y firmar voluntariamente un DCI antes de ser sometidos a cualquier evaluación/procedimiento relacionado con el estudio.

    3. Ser capaces de cumplir el calendario de visitas del estudio y el resto de requisitos del protocolo.

    4. Tener un estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2.

    5. Las mujeres en edad fértil (MEF) deberán:

    a. Presentar dos pruebas de embarazo negativas que el investigador verificará antes del inicio del tratamiento del estudio. Dichas pacientes deberán aceptar realizarse pruebas de embarazo durante el transcurso del estudio y tras finalizar el tratamiento del estudio. Este requisito debe cumplirse aunque la paciente practique la abstinencia absoluta* de relaciones sexuales heterosexuales.
    b. Comprometerse a mantener una abstinencia absoluta* de contacto heterosexual (que deberá revisarse mensualmente y documentarse), o bien comprometerse a utilizar y ser capaces de cumplir con dos métodos anticonceptivos fiables según se define en el plan de prevención del embarazo (PPE) (anexo E) de forma ininterrumpida desde los 28 días anteriores al inicio del CC-92480, durante el tratamiento del estudio (incluidas las interrupciones de su administración) y durante 28 días tras la última dosis de CC-92480 o 90 días tras la última dosis de BTZ (cohortes A, D y G) o DARA (cohortes B y E), o 6 meses tras la última dosis de CFZ (cohortes C y F), lo que ocurra antes.

    Nota: se entiende por mujer en edad fértil (MEF) una mujer que: 1) ha llegado a la menarquia en algún momento y 2) no se ha sometido a una histerectomía ni a una ovariectomía bilateral, o 3) no haya presentado un estado posmenopáusico natural (la amenorrea secundaria a los tratamientos antineoplásicos no descarta el potencial de embarazo) durante al menos 24 meses consecutivos (es decir, ha tenido la menstruación en algún momento durante los 24 meses previos consecutivos).

    6. Los pacientes varones deberán:

    a. Mantener abstinencia sexual real* (que se revisará cada mes) o comprometerse a utilizar preservativo durante las relaciones sexuales con mujeres embarazadas o en edad fértil mientras participen en el estudio (incluso durante las interrupciones de la administración del fármaco) y durante al menos 3 meses después de la suspensión del tratamiento del estudio, incluso si se han sometido a una vasectomía con éxito.

    * La abstinencia real es aceptable cuando está en consonancia con el estilo de vida preferido y habitual del sujeto. La abstinencia periódica (p. ej., métodos de Ogino, ovulación, sintotérmico o posovulación) y la marcha atrás no se consideran métodos anticonceptivos aceptables.

    7. Los pacientes varones deben aceptar no donar semen mientras estén recibiendo el tratamiento del estudio y durante al menos los 3 meses posteriores a la última dosis del tratamiento del estudio. Las mujeres deberán abstenerse de donar óvulos durante la administración del tratamiento del estudio y durante al menos 28 días tras la última dosis de CC-92480.

    8. Todos los pacientes aceptarán no donar sangre mientras estén recibiendo el tratamiento del estudio y durante28 días tras la última dosis de este.

    9. Todos los pacientes deberán cumplir con los requisitos del PPE. Véase el
    anexo E con el Plan de prevención del embarazo del CC-92480 para participantes de ensayos clínicos.

    Consulte el protocolo para conocer los criterios de inclusión adicionales para los sujetos de las cohortes A, B, C, D, E y F y para los sujetos de la cohorte G.
    E.4Principal exclusion criteria
    1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
    2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
    3. Subject has any condition that confounds the ability to interpret data from the study.
    4. Subject has any of the following laboratory abnormalities:
    a. Absolute neutrophil count (ANC) < 1,000/µL (for Phase 1 without growth factor support for ≥ 7 days [≥ 14 days for pegfilgrastim])
    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)
    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 x ULN
    g. Serum total bilirubin > 1.5 x ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome
    h. Prothrombin time (PT)/international normalized ration (INR) > 1.5 x ULN or partial thromboplastin time (PTT) > 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
    5. Subject has peripheral neuropathy ≥ Grade 2
    6. Subject with gastrointestinal disease that may significantly alter the absorption of CC-92480.
    7. 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 non-invasive malignancies:
    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer or prostate cancer that is curative
    8. Subject has plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis.
    9. Subject with known central nervous system (CNS) involvement with myeloma.
    10. Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. Please refer to protocol for exceptions to this criterion.
    11. Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
    • Left ventricular ejection fraction (LVEF) < 45% as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at Screening.
    • Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiogram (ECG) finding at Screening
    • A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval > 470 milliseconds (msec) using Fridericia’s QT correction formula; a history of or current risk factors for Torsades de Pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval
    • Congestive heart failure (New York Heart Association Class III or IV).
    • Myocardial infarction within 12 months prior to starting study treatment.
    • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
    • History of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, pericardial disease or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
    12. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.
    13. Concurrent administration of strong CYP3A modulators
    14. Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study.
    15. Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C.
    16. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, BTZ (for Cohorts A, D and G), DARA (for Cohort B), CFZ (for Cohort C) or dexamethasone.
    17. Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-92480, BTZ (for Cohorts A, D and G), DARA (for Cohorts B and E), CFZ (for Cohorts C and F) or dexamethasone.
    18. Contraindications to the standard treatment regimens, per local prescribing inform
    19. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.

    Please refer to protocol for additional exclusion criteria for subjects in Cohorts A, B, C, D, E and F and for subjects in Cohort G.
    1. Cualquier enfermedad o anomalía analítica significativas, o enfermedad psiquiátrica que pueda impedir que el paciente participe en el estudio.
    2. Cualquier enfermedad, incluida la presencia de anomalías analíticas que, de participar en el estudio, situaría al sujeto en una situación de riesgo inaceptable.
    3. Cualquier trastorno que pueda interferir con la capacidad de interpretar los datos del estudio.
    4. Cualquiera de las siguientes anomalías analíticas:
    a. Recuento absoluto de neutrófilos (RAN) <1000/µl (en la fase I sin ayuda de factor de crecimiento durante ≥7 días [≥14 días para el pegfilgrastim])
    b. Recuento de plaquetas <75 000/µl (no se admite realizar transfusiones al paciente para alcanzar este nivel)
    c. Hemoglobina <8 g/dl (<4,9 mmol/l)
    d. Aclaramiento de creatinina (CrCL) <45 ml/min
    e. Calcio sérico corregido >13,5 mg/dl (3,4 mmol/l)
    f. Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) en suero ≥2,5 veces el límite superior de la normalidad (LSN)
    g. Bilirrubina sérica total >1,5 × LSN o >3 mg/dl para pacientes con síndrome de
    Gilbert documentado
    h. Tiempo de protrombina (TP)/cociente internacional normalizado (CIN) 1,5 × LSN o tiempo de protrombina parcial (TPP) 1,5 × LSN (en pacientes que no recibananticoagulantes) Nota: los pacientes que reciban tratamiento para un acontecimiento tromboembólico que haya tenido lugar >3 meses antes de la inclusión son aptos siempre que reciban una pauta estable de anticoagulantes con warfarina, heparina de bajo peso molecular u otra pauta de anticoagulantes aprobados.
    5. El paciente padece neuropatía periférica de grado ≥2.
    6. El paciente padece una enfermedad digestiva que puede alterar de forma significativa la absorción del CC- 92480.
    7. Paciente con antecedentes de neoplasias malignas distintas del MM, a menos que no haya presentado la enfermedad durante ≥5 años, a excepción de las siguientes neoplasias no invasoras: Carcinoma basocelular, Carcinoma epidermoide, Carcinoma de cuello uterino localizado, Carcinoma de mama localizado, Hallazgo histológico incidental de cáncer de próstata (T1a o T1b de acuerdo con el sistema de estadificación clínica TNM [tumor, ganglios y metástasis]) o cáncer de próstata curable.
    8. El paciente tiene leucemia de células plasmáticas, macroglobulinemia de Waldenström, síndrome de POEMS (polineuropatía, organomegalia, endocrinopatía, componente M monoclonal y manifestaciones cutáneas) o amiloidosis clínicamente significativa.
    9. Paciente con afectación del sistema nervioso central (SNC) con mieloma.
    10. Paciente que haya recibido inmunodepresores en los 14 días anteriores al inicio del tratamiento del estudio. Las excepciones a este criterio son:
    Corticoesteroides por vía intranasal, inhalados, tópicos o en inyecciones locales (por ejemplo, inyección intraarticular), Corticoesteroides sistémicos a dosis que no superen los 10 mg/día de prednisona o equivalente, Corticoesteroides como premedicación para las reacciones de hipersensibilidad (por ejemplo, premedicación para una tomografía computerizada —TAC)
    11. Paciente con afectación de la actividad cardíaca o cardiopatía clínicamente significativa, incluida alguna de las siguientes:
    Fracción de expulsión del ventrículo izquierdo (FEVI) <45 % según ecocardiograma (ECO) o ventriculografía isotópica (MUGA) en la selección, Bloqueo de la rama izquierda del haz de His (BRIHH) bifascicular u otro resultado anómalo significativo en el ECG de la selección, Prolongación del intervalo QT en el ECG de la selección, definida por la demostración repetida de un intervalo QTc >470 milisegundos (ms) mediante la fórmula de corrección de QT de Fridericia; antecedentes o factores de riesgo actuales de taquicardia ventricular (p. ej., insuficiencia cardiaca, hipopotasemia o antecedentes familiares de síndrome de QT largo) y administración simultánea de fármacos que prolonguen el intervalo QT/QTc, Insuficiencia cardíaca congestiva (clase III-IV de la New York Heart Association), Infarto de miocardio en los 12 meses anteriores al inicio del tratamiento del estudio, Angina de pecho inestable o mal controlada, incluida la angina de Prinzmetal, Antecedentes de arteriopatía coronaria grave, arritmias ventriculares no controladas graves, disfunción sinusal, afectación pericárdica o signos electrocardiográficos de isquemia aguda o anomalías de grado 3 del sistema de conducción, a menos que al paciente tenga un marcapasos
    12. Hipertensión o diabetes no controladas en los 14 días previos a la inclusión.
    13. Administración simultánea de moduladores potentes del CYP3A (véase el apartado 8.2).
    14. Mujeres embarazadas, en periodo de lactancia o con intención de quedarse embarazadas durante su participación en el estudio.

    (Consute el protocolo para conocer los demás criterios de exlcusión así como los criterios de exclusión adicionales para los sujetos de las cohortes A, B, C, D, E y F y para los sujetos de la cohorte G)
    E.5 End points
    E.5.1Primary end point(s)
    Recommend Dose and Regimen
    Review of dose-limiting toxicities (DLTs), safety, and if applicable, pharmacokinetics (PK), pharlmacodynamics (Pd), and/or preliminary efficacy data by the Safety Review Committee (SRC)

    Safety
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment

    Overall response rate (ORR)
    Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria
    Recomendar dosis y régimen
    Revisión de toxicidades limitantes de la dosis (DLT), seguridad y, si corresponde, farmacocinética (PK), farmacodinámica (Pd) y / o datos preliminares de eficacia por el Comité de Revisión de Seguridad (SRC)

    La seguridad
    Tipo, frecuencia, gravedad y gravedad de los eventos adversos (EA) y relación de los EA con el estudio del tratamiento

    Tasa de respuesta global (ORR)
    Mejor respuesta ≥ respuesta parcial (RP), de acuerdo con los Criterios de Respuesta Uniformes del Grupo Internacional de Trabajo sobre el Mieloma (IMWG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recommend Dose and Regimen
    Phase I

    Safety
    From first subject first visit until 28 days after the last subject discontinues study
    treatment.

    Overall response rate (ORR)
    From first subject enrollment until the last subject is no longer evaluable for response or has progressed.
    Recomendar dosis y régimen
    Fase I

    La seguridad
    Desde la primera visita del primer sujeto hasta 28 días después de que el último sujeto abandone el tratamiento del estudio.

    Tasa de respuesta global (ORR)
    Desde la inclusión del primer paciente hasta que el último paciente ya no responda o ha progresado.
    E.5.2Secondary end point(s)
    Time-to-response (TTR)
    Time from first dose to the first documentation of response (PR or greater)

    Duration of response (DOR)
    Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death

    Complete Response (CR) rate
    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria

    Very good partial response (VGPR) rate (Cohorts D and E)
    Percentage of subjects who achieved VGPR or better according to IMWG
    Uniform Response Criteria
    Tiempo de respuesta (TTR)
    Tiempo desde la primera dosis hasta la primera documentación de respuesta (RP o mayor)

    Duración de la respuesta (DOR)
    Tiempo desde la primera documentación de respuesta (RP o mayor) hasta la primera documentación de enfermedad progresiva (EP) o muerte

    Tasa de respuesta completa (CR)
    Porcentaje de sujetos que obtuvieron CR o mejor según los criterios de respuesta uniforme de IMWG

    Muy buena tasa de respuesta parcial (VGPR) (Cohortes D y E)
    Porcentaje de sujetos que lograron VGPR o mejor de acuerdo con IMWG
    Criterios de respuesta uniformes
    E.5.2.1Timepoint(s) of evaluation of this end point
    From first subject enrollment until the last subject is no longer evaluable for response or has progressed.
    Desde la inclusión del primer paciente hasta que el último paciente ya no responda o ha progresado.
    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 No
    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 for Phase 2 portion of study
    Hallazgo de dosis para la fase 2 de la parte del estudio
    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 No
    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 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 No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Italy
    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 primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    La finalización del estudio se define como la fecha de la última visita del último sujeto para completar el seguimiento posterior al tratamiento, o la fecha de recepción del los últimos datos del último sujeto que es requerida para los análisis primarios, secundarios o exploratorios, como se especifica previamente en el protocolo, cualquiera que sea la fecha posterior.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 238
    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 Decision2019-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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