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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   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:2016-000860-40
    Sponsor's Protocol Code Number:CC-220-MM-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000860-40
    A.3Full title of the trial
    A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple Myeloma
    Studio di Fase 1b/2a, multicentrico, in aperto, di incremento della dose per determinare la Massima Dose Tollerata, valutare la sicurezza, la tollerabilità, la farmacocinetica e l’efficacia di CC-220 somministrato come monoterapia e in combinazione con altri regimi di trattamento in soggetti con mieloma multiplo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to decide what is the highest dose of CC-220 to take alone and with other standard of care treatments to assess the side effects, effectiveness and how the body deals with the drug in patients with multiple myeloma
    Uno studio per decidere quale sia la dose massima di CC-220 da assumere da solo e con altri trattamenti standard di cura per valutare gli effetti collaterali, l’efficacia e come l’organismo elabora il farmaco nei pazienti affetti da mieloma multiplo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCC-220-MM-001
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 Address86 Morris Avenue
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post codeNJ 07901
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019137096862
    B.5.5Fax number000000000
    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-220
    D.3.2Product code n.a.
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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-220
    D.3.2Product code n.a.
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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-220
    D.3.2Product code n.a.
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Desametasone compresse B.P. 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 nameDesametasone
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor coden.a.
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Desametasone-Ratiopharm compresse 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDesametasone
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameDexamethasone-Ratiopharm 4 mg
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 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-220
    D.3.2Product code n.a.
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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-220
    D.3.2Product code n.a.
    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 INNC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 DARZALEX
    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.3.1Product nameDaratumumab
    D.3.2Product code [HuMax-CD38]
    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 codena
    D.3.9.4EV Substance CodeSUB29447
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 typehuman monoclonal antibody
    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 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-220
    D.3.2Product code [na]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 10
    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-220
    D.3.2Product code [na]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 11
    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-220
    D.3.2Product code [NA]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 12
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-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.3.1Product nameVELCADE 1 mg powder for solution for injection
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.2Current sponsor codena
    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 number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 13
    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 60mg 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.3.2Product code [PR-171]
    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.3.9.2Current sponsor codecarfilzomib
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 14
    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-220
    D.3.2Product code [CC-220]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 15
    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-220
    D.3.2Product code [CC-220]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 16
    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-220
    D.3.2Product code [CC-220]
    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 INNCC-220
    D.3.9.1CAS number 1560678-63-8
    D.3.9.2Current sponsor codeCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 17
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name desametasone comprese B.P. 2 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma trading Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedesametasone
    D.3.2Product code [n.a.]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor coden.a.
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Myeloma
    Mieloma Multiplo
    E.1.1.1Medical condition in easily understood language
    A blood cancer that forms in a type of white blood cell called a plasma cell.
    Italiano Tumore del sangue che si forma in un tipo di globuli bianchi chiamati plasmacellule.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067095
    E.1.2Term Multiple myeloma progression
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    To determine the maximum tolerated doses (MTDs) and/or RP2D of CC-220 as monotherapy (MonoT), in combination with DEX (DoubleT), in combination with DEX and daratumumab (DARA) (CC-220Dd), in combination with DEX and bortezomib (BTZ) (CC-220Vd)and in combination with DEX and carfilzomib (CFZ) (CC-220Kd) in subjects with RRMM.

    Part 2
    To determine the efficacy of CC-220 in combination with DEX (Double T)
    in subjects with RRMM nella Coorte D, as measured by overall response rate
    (ORR).
    Parte 1
    Determinare le massime dosi tollerate (MTD) e/o dosi raccomandate della Fase 2 (RP2D) di CC-220 in monoterapia (MonoT), in combinazione con desametazone (DEX) (DoubleT), in combinazione con DEX e daratumumab (DARA) (CC-220Dd), in combinazione con DEX e bortezomib (BTZ) (CC-220Vd) e in combinazione con DEX e carfilzomib (CFZ) (CC-220Kd) n soggetti affetti da RRMM
    Parte 2
    Determinare l'efficacia di CC-220 in combinazione con DEX (DoubleT) in soggetti con RRMM nella coorte D in base a misurazione del tasso di risposta globale (ORR).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of CC-220 as MonoT, in combination with DEX
    (DoubleT), in combination with DEX and DARA ,in combination with DEX
    and BTZ and in combination with DEX and CFZ in subjects with RRMM.
    - To evaluate the preliminary efficacy and safety of CC-220Vd in subjects
    with NDMM, including subjects who are eligible for ASCT and subjects
    who are not eligible for ASCT.
    -To evaluate additional efficacy parameters of CC-220 in combination
    with DEX including time-to-response (TTR), duration of response (DOR),
    progression-free survival (PFS), and overall survival (OS) in subjects
    with RRMM in Cohort D.
    - To estimate the preliminary efficacy of CC-220 as MonoT, in
    combination with DEX and DARA, in combination with DEX & BTZ and in
    combination with DEX and CFZ in subjects with RRMM.
    - To evaluate the pharmacokinetics (PK) of CC-220 in subjects with
    RRMM and NDMM.
    - Valutare la sicurezza di CC-220 in MonoT, in combinazione con DEX (DoubleT), in combinazione con DEX e DARA (CC-220Dd), in combinazione con DEX e BTZ (CC-220Vd) e in combinazione con DEX e CFZ (CC-220Kd) in soggetti affetti da RRMM.
    - Valutare l’efficacia preliminare e la sicurezza di CC-220 in combinazione con DEX e bortezomib (CC-220Vd) in soggetti con NDMM, inclusi soggetti idonei per ASCT e soggetti non idonei per ASCT.
    - Valutare parametri di efficacia aggiuntivi di CC-220 in combinazione con DEX, compreso il tempo alla risposta (TTR), la durata della risposta (DOR), la sopravvivenza libera da malattia (PFS) e la sopravvivenza globale (OS) in soggetti affetti da RRMM nella Coorte D.
    - Valutare l’efficacia preliminare di CC-220 in MonoT, in combinazione con DEX e DARA (CC-220Dd), in combinazione con DEX e BTZ (CC-220Vd) e in combinazione con DEX e CFZ (CC-220Kd) in soggetti affetti da RRMM.
    - Valutare la farmacocinetica (PK) di CC-220 in soggetti affetti da RRMM e NDMM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria:
    1. Subject is =18 years of age at the time of signing the 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. All subjects in RRMM cohorts must have a documented diagnosis of
    MM and have measurable disease defined as: a. M-protein (serum and/or
    urine protein electrophoresis (sPEP or 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 urine:
    serum immunoglobulin free light chain = 10 mg/dL (100 mg/L) and
    abnormal serum immunoglobulin kappa lambda free light chain ratio
    5. Subjects in Cohorts A,B,C, E, G1 and G2 must have received at least 2
    prior myeloma regimens (note: induction with or without bone marrow
    transplant and with or without maintenance therapy is considered one
    regimen). Subjects in Cohort F must have received at least 1 prior
    myeloma regimen. Subjects in Cohorts D and I must have received at
    least 3 prior myeloma regimens.
    6. All subjects in RRMM cohorts must have received prior treatment with
    at least 2 consecutive cycles of a lenalidomide or pomalidomidecontaining
    regimen. Subjects in Cohort D must have received prior
    treatment with at least 2 consecutive cycles of a lenalidomide-containing
    regimen and at least 2 consecutive cycles of a pomalidomide-containing
    regimen.
    7. All subjects in RRMM cohorts must have received prior treatment with
    at least 2 consecutive cycles of a proteasome inhibitor or a proteasome
    inhibitor-containing regimen
    8. For Part 2 RRMM cohorts (Cohorts C,D,and I) all subjects must have
    received prior treatment with at least 2 consecutive cycles of a CD38
    antibody or a CD38 antibody-containing regimen
    9. All subjects in RRMM cohorts must have documented disease
    progression on or within 60 days from the last dose of their last
    myeloma therapy. Subjects who had CAR T therapy as their last myeloma
    therapy must have documented disease progression.
    10. Eastern Cooperative Oncology Group (ECOG) performance status
    score of 0, 1 or 2
    11. Please refer to the protocol page 68 for a discussion on the criteria
    for a female of childbearing potential.
    12. Please refer to the protocol page 68 for a discussion on the
    conditions of practicing true abstinence for male subjects.
    13. Males must agree to refrain from donating sperm while on study
    treatment, during dose interruptions and for at least 90 days following
    last dose of study treatment.
    14. All subjects must agree to refrain from donating blood while on study
    treatment, during dose interruptions and for at least 28 days following
    the last dose of study treatment.
    15. All male and female subjects must follow all requirements defined in
    the Pregnancy Prevention Program. See Appendix D of the protocol for
    CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials
    16. Subjects in Cohort D must have received prior treatment with at
    least 2 consecutive cycles of a glucocorticoid-containing regimen.
    17. Subjects in Cohort D must be refractory to an ID agent, a proteasome
    inhibitor, a glucocorticoid and a CD38 antibody.
    18.Subjects in Cohort I must have received prior treatment with a BCMA targeted therapy.
    Additional Inclusion Criteria for Part 2 Cohorts J1 and J2 (CC-220 + BTZ + DEX in NDMM) are listed on page 62 of the protocol.
    I soggetti devono soddisfare i seguenti criteri:
    1. età>=18 anni al momento della firma dell’ICF
    2. comprendere e sottoscrivere volontariamente un ICF prima che sia condotta qualsiasi valutazione/procedura correlata allo studio
    3. accetta ed è in grado di aderire al programma delle visite dello studio e agli altri requisiti del protocollo
    4. Tutti i soggetti nelle coorti RRMM devono avere una diagnosi documentata di MM e presentare una malattia misurabile definita come:
    a. proteina-M (elettroforesi delle proteine sieriche e/o urinarie (sPEP o uPEP)): sPEP =0,5 g/dl o uPEP =200 mg/24 ore e/o
    b. Catena leggera MM senza malattia misurabile nel siero o nelle urine: catena leggera libera dell’immunoglobulina del siero =10 mg/dL (100 mg/L) e rapporto anormale della catena leggera kappa/lambda dell’immunoglobulina del siero
    5. I soggetti nelle Coorti da A, B, C, E, G1 e G2 devono aver ricevuto almeno 2 regimi precedenti per il mieloma (nota: l'induzione con o senza trapianto di midollo osseo e con o senza terapia di mantenimento è considerata un regime). I soggetti nella Coorte F devono aver ricevuto almeno 1 regime precedente per il mieloma. I soggetti delle Coorti D e I devono aver ricevuto almeno 3 precedenti regimi per il mieloma
    6. Tutti i soggetti nelle coorti RRMM devono aver ricevuto un precedente trattamento con almeno 2 cicli consecutivi di un regime contenente lenalidomide o pomalidomide. I soggetti della Coorte D devono aver ricevuto un precedente trattamento con almeno 2 cicli consecutivi di un regime contenente lenalidomide e almeno 2 cicli consecutivi di un regime contenente pomalidomide.
    7. Tutti i soggetti nelle coorti RRMM devono aver ricevuto un precedente trattamento con almeno 2 cicli consecutivi di un inibitore proteasomico o di un regime contenente un inibitore proteasomico
    8. Per la Parte 2 coorti RRMM (Coorti C, D e I), aver ricevuto un trattamento precedente con almeno 2 cicli consecutivi di un anticorpo CD38 o di un regime contenente anticorpo CD38
    9. Tutti i soggetti nelle coorti RRMM devono presentare progressione di malattia documentata durante l’ultima terapia ricevuta per il mieloma o entro 60 giorni dall’ultima dose di tale terapia. I soggetti che sono stati sottoposti a terapia CAR T come ultima terapia per il mieloma devono avere una progressione di malattia documentata.
    10. ECOG PS = 0,1 o 2
    11. Fare riferimento alla pagina 68 del protocollo per una discussione sui criteri
    per una donna in età fertile.
    12. Fare riferimento alla pagina 68 del protocollo per una discussione sulle condizioni della pratica dell’astinenza reale per i soggetti di sesso maschile
    13. I soggetti di sesso maschile devono acconsentire ad astenersi dal donare sperma durante la terapia con CC-220, durante le interruzioni della dose e per almeno 90 giorni dopo l’ultima dose di CC-220.
    14. acconsentire ad astenersi dal donare sangue durante la terapia con CC-220, durante le interruzioni della dose e per almeno 28 giorni dopo l'ultima dose di CC-220.
    15. Tutti i soggetti di sesso maschile e femminile devono seguire tutti i requisiti definiti nel Programma di Prevenzione della Gravidanza. Si veda l’appendice D del protocollo
    16. I soggetti della Coorte D devono aver ricevuto un precedente trattamento con almeno 2 cicli consecutivi di un regime contenente glucocorticoidi.
    17. I soggetti della Coorte D devono essere refrattari a un agente ID, a un inibitore del proteasoma, a un glucocorticoide e a un anticorpo CD38.
    18. I soggetti nella Coorte I devono aver ricevuto un trattamento precedente con una terapia diretta contro BCMA.
    Nel protocollo a pagina 62 sono elencati ulteriori Criteri di inclusione per la Parte 2 Coorti J1 e J2 (CC-220 + BTZ + DEX nel NDMM).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from
    enrollment:
    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 nonsecretory or oligosecretory multiple myeloma
    5. Subjects with Plasma Cell leukemia or amyloidosis
    6. Any of the following laboratory abnormalities
    ·Absolute neutrophil count (ANC) <1,000/µL
    ·Platelet count <75,000/µL for Part 1. For Part 2; platelet count <
    75,000/µL for subjects in whom < 50% of bone marrow nucleated cells
    are plasma cells; otherwise platelet count < 50,000/µL(transfusions are
    not permitted to achieve minimum platelet counts)
    ·Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
    ·Serum glutamic oxaloacetic transaminase (SGOT)/aspartate
    aminotransferase (AST) or serum glutamic pyruvic transaminase
    (SGPT)/alanine aminotransferase (ALT) =2.0 x upper limit of normal
    (ULN)
    ·Serum total bilirubin and alkaline phosphatase >1.5 x ULN
    ·Subjects with serious renal impairment (creatinine clearance [CrCl]
    <45 mL/min) or requiring dialysis would be excluded
    7. Subjects with peripheral neuropathy =Grade 2
    8. Subjects with gastrointestinal disease that may significantly alter the
    absorption of CC-220
    9. Subjects with a 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:
    ·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 histological findings of prostate cancer such as T1a or T1b
    using the Tumor/Node/Metastasis (TNM) classification of malignant
    tumors or prostate cancer that is curative
    10. Subject has a history of anaphylaxis or hypersensitivity to
    thalidomide, lenalidomide, pomalidomide, DEX, daratumumab (for
    Cohort E), bortezomib (for Cohort F, J1 and J2) or carfilzomib (for
    Cohorts G1 and G2)
    Subject has known or suspected hypersensitivity to the excipients
    contained in the formulation of CC-220, DEX, daratumumab (for Cohort
    E), bortezomib (for Cohort F, J1 and J2) or carfilzomib (for Cohorts G1
    and G2).
    11. Contraindications to the other treatment regimens, as per local
    prescribing information
    12. Subject has received any of the following within the last 14 days of
    initiating IP:
    ·Plasmapheresis
    ·Major surgery (as defined by the Investigator)
    ·Radiation therapy other than local therapy for MM associated bone lesion
    ·Use of any systemic myeloma drug therapy
    13, Subject has been treated with an investigational agent (ie, an agent
    not commercially available) within 28 days or 5 half-lives (whichever is
    longer) of initiating IP. Not applicable for subjects who had CAR T as last
    prior regimen.
    14. Subject has any one of the following:
    ·Clinically significant abnormal electrocardiogram (ECG) finding at
    Screening
    ·Congestive heart failure (New York Heart Association Class III or IV)
    ·Myocardial infarction within 12 months prior to starting IP
    ·Unstable or poorly controlled angina pectoris, including the Prinzmetal
    variant of angina pectoris
    15. Subject has current or prior use of immunosuppressive medication
    within 14 days prior to the first dose of IP. The following are exceptions
    to this criterion:
    ·Intranasal, inhaled, topical or local steroid injections (eg, intra-articular
    injection)
    ·Systemic corticosteroids at physiologic doses that do not exceed 10
    mg/day of prednisone or equivalent
    ·Steroids as premedication for hypersensitivity reactions (eg, computed
    tomography [CT] scan premedication)

    Additional Exclusion Criteria for Cohorts E, F, G1 ,G2, J1 and J2 can be
    found on pages 72 and 73 of the protocol.
    1. Qualsiasi condizione medica significativa, anomalia di laboratorio o patologia psichiatrica che potrebbe impedire al soggetto di partecipare allo studio
    2. Qualsiasi condizione, inclusa la presenza di anomalie di laboratorio, che esponga il soggetto a un rischio inaccettabile in caso di partecipazione allo studio
    3. Qualsiasi condizione che possa confondere la capacità di interpretare i dati dello studio
    4. mieloma multiplo non secretorio od oligosecretorio
    5. Soggetti con leucemia plasmacellulare o amiloidosi
    6. Qualsiasi delle seguenti anomalie di laboratorio
    -Conta assoluta dei neutrofili (ANC) <1.000/µl
    -Conta piastrinica <75.000/µl per la Parte 1. Per la Parte 2, conta piastrinica <
    75.000/µl per soggetti nei quali <50% delle cellule nucleate del midollo osseo sono plasmacellule; altrimenti conta piastrinica <50.000/µl (le trasfusioni non sono permesse per raggiungere la conta piastrinica minima)
    -Calcio sierico corretto >13,5 mg/dl (>3,4 mmol/l)
    -Transaminasi glutammico-ossalacetica sierica (SGOT)/aspartato aminotransferasi (AST) o transaminasi glutammico-piruvica sierica (SGPT)/alanina aminotransferasi (ALT)> =2,0 x ULN
    -Livelli sierici di bilirubina totale e fosfatasi alcalina >1,5 x l’ULN
    -I soggetti con insufficienza renale grave (clearance della creatinina[CrCl] <45 ml/min) o necessità di dialisi sono esclusi
    7. Neuropatia periferica di grado >=2
    8. Patologia gastrointestinale che possa alterare significativamente l’assorbimento di CC-220
    9. Anamnesi pregressa di tumori maligni diversi dal MM, salvo il caso in cui il soggetto sia libero da malattia da >=5 anni, con l’eccezione dei seguenti tumori maligni non invasivi:
    - Carcinoma cutaneo basocellulare
    - Carcinoma cutaneo squamocellulare
    - Carcinoma in situ della cervice
    - Carcinoma in situ della mammella
    - Reperti istologici incidentali di tumore prostatico, ad esempio tumore T1a o T1b secondo la classificazione
    10. Il soggetto ha avuto un'anamnesi di anafilassi o ipersensibilità a talidomide, lenalidomide, pomalidomide, DEX, daratumumab (per la Coorte E) o bortezomib (per la Coorte F, J1 e J2) o carfilzomib (per le Coorti G1 e G2)
    11. Controindicazioni agli altri regimi di trattamento, in base alle informazioni locali relative alla prescrizione
    12. Il soggetto ha ricevuto una qualsiasi delle seguenti nei 14 giorni precedenti l’avvio della terapia con il prodotto sperimentale:
    - Plasmaferesi
    - Intervento chirurgico maggiore (come definito dallo sperimentatore)
    - Radioterapia diversa dalla terapia locale per lesioni ossee associate al MM
    - Qualsiasi terapia farmacologica sistemica per il mieloma
    13. trattamento con un agente sperimentale entro 28 giorni o 5 emivite (a seconda di quale sia il periodo più lungo) prima dell’avvio della terapia con il prodotto sperimentale. Non applicabile a soggetti in cui CAR T è stato l’ultimo regime di trattamento precedente.
    14. una qualsiasi delle seguenti condizioni:
    - Anomalia CS di un reperto elettrocardiografico (ECG) allo screening
    - Insufficienza cardiaca congestizia (classe III o IV secondo la classificazione della NYHA
    - IMA nei 12 mesi precedenti l’avvio della terapia con il prodotto sperimentale
    - Angina pectoris instabile o scarsamente controllata, inclusa la variante di Prinzmetal dell’angina pectoris
    15. Impiego attuale o pregresso di farmaci immunosoppressori nei 14 giorni precedenti la prima dose del prodotto sperimentale. Fanno eccezione a tale criterio:
    • Steroidi somministrati per via intranasale, inalatoria, topica o mediante iniezioni locali (ad es., iniezione intrarticolare)
    • Corticosteroidi per via sistemica a dosi fisiologiche, non superiori a 10 mg/die di prednisone o equivalente
    • Steroidi somministrati come premedicazione per le reazioni da ipersensibilità (ad es., premedicazione per esame di tomografia computerizzata [TAC])

    Ulteriori Criteri di esclusione per le Coorti E, F, G1, G2, J1 e J2 si trovano
    alle pagine 72 e 73 del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Recommended Dose and regimen in Part 1 - Establish the maximum tolerated doses (MTDs) and or Recommended Phase 2 doses (RP2Ds) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (C220Dd) in combination with DEX and bortezomib (C220Vd),and in combination with DEX and carfilzomib (CC- 220Kd).
    Overall response rate
    (ORR) in Cohort D -Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Rajkumar, 2011) in CC-220 in combination with DEX
    Dose e regime raccomandati nella Parte 1_Stabilire le dosi massime tollerate (MTD) e/o dosi raccomandate della Fase 2 (RP2D) di CC 220 in monoterapia, in combinazione con DEX, e in combinazione con DEX e daratumumab (C220Dd) in combinazione con DEX e bortezomib (C220Vd), e in combinazione con DEX e carfilzomib (C220Kd)

    Tasso di risposta complessiva
    (ORR) nella coorte D- Risposta del tumore, compresa la progressione della malattia (PD) in base ai criteri di risposta uniformi dell’International Myeloma Working Group (IMWG) (Rajkumar, 2011) in CC-220 in combinazione con DEX
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint of Recommended Dose and Regimen in Part 1- Part 1
    Overall response rate(ORR) in Cohort D- From first subject first dose of
    IP until the last subject is no longer evaluable for response or has
    progressed.
    Further details are available in the clinical study protocol
    L’Endpoint della Dose e Regime raccomandati nella Parte 1- Parte 1
    Tasso di risposta globale (ORR) nella coorte D- Dalla prima dose di IP del primo soggetto fino a quando l'ultimo soggetto non sia più valutabile per la risposta o sia progredito.
    Sono disponibili ulteriori dettagli nel protocollo di studio clinico
    E.5.2Secondary end point(s)
    Safety - Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
    Very good partial response or better rate (VGPR) - Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved VGPR or better.
    Overall response rate (ORR) - Tumour response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved partial response (PR) or better

    Time to response (TTR) - Time from enrollment 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 PD.
    Progression free survival (PFS) - Time from the first dose of
    investigational product (IP) to the first documentation of PD or death
    from any cause, whichever occurs first.
    Overall Survival (OS) in Part 2 RRMM cohorts- Time from first dose of IP
    to death due to any cause.
    Pharmacokinetic (PK) parameters- PK of CC-220, and as appropriate, its
    R-enantiomer CC-17195 in plasma, eg, area under the plasma
    concentration-time curve from time zero to tau, where tau is the dosing
    interval (AUC0-t), maximum plasma concentration of drug (Cmax), time
    to Cmax (Tmax), terminal-phase elimination half -life (t1/2), apparent
    total plasma clearance when dosed daily (CLss/F), apparent total
    volume of distribution at steady state when dosed orally (Vss/F)
    - Sicurezza - Tipo, frequenza, serietà e gravità degli eventi avversi (EA) (e degli EA di particolare interesse) e relazione degli EA con il prodotto sperimentale.
    Risposta parziale molto buona o superiore (VGPR) – Risposta del tumore, compresa progressione della malattia (PD) secondo i Criteri di risposta uniformi del Gruppo di lavoro internazionale sul mieloma (IMWG) per i soggetti che hanno raggiunto una risposta VGPR o superiore.
    Tasso di risposta globale (ORR) - Risposta del tumore, compresa progressione della malattia (PD) secondo i Criteri di risposta uniformi del Gruppo di lavoro internazionale sul mieloma (IMWG) per i soggetti che hanno raggiunto la risposta parziale (PR) o superiore
    Tempo alla risposta (TTR) - Tempo dall’arruolamento alla prima risposta documentata (PR o superiore).
    Durata della risposta (DOR) - Tempo dalla prima risposta documentata (PR o superiore) alla prima PD documentata.
    Sopravvivenza libera da progressione (PFS) - Tempo dalla prima dose di prodotto sperimentale (IP) alla prima PD documentata o al decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo.
    Sopravvivenza globale (OS) nelle coorti RRMM della Parte 2 - Tempo dalla prima dose di IP
    al decesso per qualsiasi causa.
    Parametri di farmacocinetica (PK) - PK di CC-220 e, secondo quanto appropriato, il suo enantiomero R CC-17195 nel plasma, per es. area sotto la curva concentrazione-tempo plasmatica dal tempo zero a tau, in cui tau è l’intervallo di dosaggio (AUC0-t), concentrazione massima plasmatica di farmaco (Cmax), tempo al Cmax (Tmax), emivita di eliminazione terminale (t1/2), clearance plasmatica totale apparente con dosaggio giornaliero (CLss/F), volume totale apparente di distribuzione allo stato stazionario con dosaggio giornaliero (Vss/F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety - From first subject first visit until 28 days after the last subject
    discontinues study treatment.
    VGPR - From first subject dose of IP until the last subject is no longer
    evaluable for response or has progressed.
    ORR- From first subject dose of IP until the last subject is no longer
    evaluable for response or has progressed.
    TTR- From first subject dose of IP until the last subject is no longer
    evaluable for response or has progressed.
    DOR- From first subject dose of IP until the last subject is no longer
    evaluable for response or has progressed
    PFS- From first subject first dose of IP until the last subject discontinues
    study
    OS in Part 2 RRMM cohorts-From first subject dose of IP until the last
    subject discontinues study.
    PK Parameters - During study treatment.
    Sicurezza - Dalla prima visita del primo sogg.fino a 28 giorni dopo l’interruzi. da parte dell'ultimo sogg.del trattamento di studio.
    VGPR - Dalla prima dose di IP del sogg. fino a quando l'ultimo sogg. non sia più valutabile per la risposta o sia progredito.
    ORR - Dalla prima dose di IP del soggetto fino a quando l'ultimo sogg. non sia più valutabile per la rispo. o sia progredito.
    TTR - Dalla prima dose di IP del sogg.fino a quando l'ultimo sogg. non sia più valutabile per la rispo. o manifesta progressione.
    PFS-Dalla prima dose di IP del primo sogg. fino a quando l'ultimo sogg. non si ritiri dallo studio.
    OS nelle Coorti RRMM nella Parte 2 - dalla prima dose di IP in un soggetto fino a quando l’ultimo
    soggetto termina lo studio.
    Parametri PK - Durante il trattamento dello studio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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
    Phase 1B / 2A
    Fase 1B / 2A
    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 No
    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 trial1
    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 EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Italy
    Japan
    Netherlands
    Spain
    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 long-term follow-up data collection, 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.
    Il termine dello studio ¿ definito come la data dell¿ultima raccolta dati per follow-up a lungo termine, oppure la data di ricevimento dell¿ultimo punto dati dell¿ultimo soggetto, richiesto per l¿analisi primaria, secondaria e/o esplorativa, come predefinito nel protocollo, qualunque sia la data che si verifica più tardi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 231
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 212
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 443
    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.
    Nessuno.
    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 Decision2016-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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