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    Summary
    EudraCT Number:2016-003097-41
    Sponsor's Protocol Code Number:EFC14335
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2016-003097-41
    A.3Full title of the trial
    A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination with Pomalidomide and Low-dose Dexamethasone versus Pomalidomide and Low-dose Dexamethasone in Patients with Refractory or Relapsed and Refractory Multiple Myeloma
    Φάσης 3, τυχαιοποιημένη, ανοικτή, πολυκεντρική μελέτη σύγκρισης του isatuximab (SAR650984) σε συνδυασμό με πομαλιδομίδη και χαμηλής δόσης δεξαμεθαζόνη έναντι της πομαλιδομίδης και χαμηλής δόσης δεξαμεθαζόνης σε ασθενείς με ανθεκτικό ή υποτροπιάζον και ανθεκτικό πολλαπλό μυέλωμα
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
    Πολυεθνική κλινική δοκιμή που δυγκρίνει το isatuximab, την πομαλιδομίδη και τη δεξαμεθαζόνη έναντι της πομαλιδομίδης και της δεξαμεθαζόνης σε ασθενείς με ανθεκτικό ή υποτροπιάζον και ανθεκτικό πολλαπλό μυέλωμα
    A.3.2Name or abbreviated title of the trial where available
    ICARIA-MM
    A.4.1Sponsor's protocol code numberEFC14335
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-6262
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Aventis ΑΕΒΕ
    B.5.2Functional name of contact pointAlexandra Panoussi
    B.5.3 Address:
    B.5.3.1Street Address348 Syngrou Avenue, Building A
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code17674
    B.5.3.4CountryGreece
    B.5.4Telephone number00302109001648
    B.5.5Fax number00302109243712
    B.5.6E-mailAlexandra.Panoussi@sanofi.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1268
    D.3 Description of the IMP
    D.3.2Product code SAR650984
    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 INNisatuximab
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    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 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 Yes
    D.2.1.1.1Trade name Imnovid 4mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIMNOVID
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Imnovid 3mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIMNOVID
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Imnovid 2mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIMNOVID
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Imnovid 1mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIMNOVID
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Dexamethason 4 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holderJENAPHARM
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    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: 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 Dexamethason 8 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holderJENAPHARM
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 3.3 mg/mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderHameln Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.4Pharmaceutical form 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 BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.3
    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
    Haematological malignancy
    αιματολογική κακοήθεια
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    καρκίνος του αίματος
    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 PT
    E.1.2Classification code 10035226
    E.1.2Term Plasma cell myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma (MM).
    Να καταδειχθεί το όφελος του isatuximab σε συνδυασμό με πομαλιδομίδη και χαμηλής δόσης δεξαμεθαζόνη στην παράταση της Επιβίωσης Χωρίς Εξέλιξη της Νόσου (PFS) σε σύγκριση με πομαλιδομίδη και χαμηλής δόσης δεξαμεθαζόνη σε ασθενείς με ανθεκτικό ή υποτροπιάζον και ανθεκτικό πολλαπλό μυέλωμα (ΠΜ).
    E.2.2Secondary objectives of the trial
    -To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
    -To compare the Overall Survival (OS) between the two arms.
    -To evaluate the Time To Progression (TTP) in each arm.
    -To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in each arm.
    -To evaluate the Duration of Response (DOR) in each arm.
    -To evaluate the safety in both treatment arms.
    -To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
    -To evaluate the immunogenicity of isatuximab.
    -To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
    -Να αξιολογηθεί το Συνολικό Ποσοστό Ανταπόκρισης (ORR) σύμφωνα με τα κριτήρια της Διεθνούς Ομάδας Εργασίας για το Μυέλωμα (IMWG) σε κάθε σκέλος
    -Να συγκριθεί η Συνολική Επιβίωση (OS) μεταξύ των δύο σκελών
    -Να αξιολογηθεί ο Χρόνος έως την Εξέλιξη της Νόσου (TTP) σε κάθε σκέλος
    -Να αξιολογηθεί η PFS στον πληθυσμό των ασθενών με υψηλού κινδύνου κυτταρογενετικές μεταβολές σε κάθε σκέλος
    -Να αξιολογηθεί η Διάρκεια της Ανταπόκρισης (DOR) σε κάθε σκέλος
    -Να αξιολογηθεί η ασφάλεια στα δύο σκέλη θεραπείας.
    -Να προσδιοριστεί το προφίλ φαρμακοκινητικής (PK) του isatuximab σε συνδυασμό με πομαλιδομίδη
    -Να αξιολογηθεί η ανοσογονικότητα του isatuximab
    -Να αξιολογηθούν η ειδική για τη νόσο και η συνολική σχετιζόμενη με την υγεία ποιότητα ζωής (HRQL), τα σχετιζόμενα με τη νόσο και τη θεραπεία συμπτώματα, η ωφελιμότητα για την κατάσταση της υγείας και η κατάσταση της υγείας.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age superior or equal to 18 years or country’s legal age of majority if the legal age is superior to 18 years old.
    -Patients must have a documented diagnosis of multiple myeloma with evidence of measurable disease i.e. serum M protein superior or equal to 0.5 g per dL measured using serum protein immunoelectrophoresis and or urine M protein superior or equal to 200 mg per 24 hours measured sing urine protein immunoelectrophoresis.
    -Patients must have received at least 2 prior lines of anti-myeloma therapy, which must include at east 2 consecutives cycles of lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
    -Patients must have failed treatment with lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination.
    -Patients must have progressed on or within 60 days after end of previous therapy before to study entry, i.e., refractory to the last line of treatment.
    -Ηλικία ≥18 ετών ή της νόμιμης ηλικίας ενηλικίωσης της χώρας εάν η νόμιμη ηλικία ενηλικίωσης είναι >18 ετών.
    -Οι ασθενείς πρέπει να έχουν τεκμηριωμένη διάγνωση πολλαπλού μυελώματος με ενδείξεις μετρήσιμης νόσου. π.χ. Πρωτεΐνη M ορού ≥0,5 g/dL, όπως μετράται με χρήση ανοσοηλεκτροφόρησης πρωτεϊνών ορού και/ή Πρωτεΐνη M ούρων ≥200 mg/24 ώρες, όπως μετράται με χρήση ανοσοηλεκτροφόρησης πρωτεϊνών ούρων
    -Οι ασθενείς θα πρέπει να έχουν λάβει τουλάχιστον 2 προηγούμενες γραμμές θεραπείας κατά του μυελώματος, οι οποίες θα πρέπει να περιλαμβάνουν τουλάχιστον 2 συνεχόμενους κύκλους με λεναλιδομίδη και έναν αναστολέα πρωτεασώματος (βορτεζομίμπη, καρφιλζομίμπη ή ixazomib) ως μονοθεραπεία ή σε συνδυασμό.
    -Οι ασθενείς πρέπει να έχουν αποτύχει σε θεραπεία με λεναλιδομίδη και έναν αναστολέα πρωτεασώματος (βορτεζομίμπη, καρφιλζομίμπη ή ixazomib) μεμονωμένα ή σε συνδυασμό.
    -Οι ασθενείς πρέπει να έχουν εμφανίσει εξέλιξη της νόσου κατά τη διάρκεια της προηγούμενης θεραπείας ή εντός 60 ημερών μετά το τέλος της, πριν από την ένταξη στη μελέτη, δηλ., να είναι ανθεκτικοί στην τελευταία γραμμή θεραπείας.
    E.4Principal exclusion criteria
    -Primary refractory multiple myeloma defined as patients who have never achieved at least a minimal response (MR) with any treatment during the disease course.
    -Free Light Chain measurable disease only.
    -Prior therapy with pomalidomide.
    -Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
    -Eastern Cooperative Oncology Group performance status superior to 2.
    -Platelets inferior to 75 000 cells per µL if inferior to 50% of bone marrow (BM) nucleated cells are plasma cells, and inferior to 30 000 cells per µL if superior or equal to 50% of BM nucleated cells are plasma cells. Platelet transfusion is not allowed within three days before the screening visit.
    -Absolute neutrophils count inferior to 1000 per μL (1 x 10E9/L). The use of G-CSF is not allowed to reach this level.
    -Creatinine clearance inferior to 30 mL per min (MDRD Formula).
    -Total bilirubin superior to 2 x ULN (Upper Limit of Normal).
    -Corrected serum calcium superior to 14 mg per dL (superior to 3.5 mmol per L).
    -Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) superior to 3 x ULN.
    -Hypersensitivity to IMiDs (thalidomide or lenalidomide) defined as any hypersensitivity reaction leading to stop IMiDs within the 2 first cycles or toxicity, which does meet intolerance definition.
    -Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, or H2 blockers that would prohibit further treatment with these agents.
    -Significant cardiac dysfunction; myocardial infarction within 12 months; unstable, poorly controlled angina pectoris.
    -Pregnant or breastfeeding woman or female who intends to become pregnant during the participation in the study.
    -Male participants who disagree to practice true abstinence or disagree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and at least 3 months following study treatment discontinuation, even if he has undergone a successful vasectomy.
    -All patients who disagree to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment.
    -Πρωτοπαθές ανθεκτικό πολλαπλό μυέλωμα, που ορίζεται ως εξής: ασθενείς που δεν έχουν ποτέ επιτύχει τουλάχιστον ελάχιστη ανταπόκριση (MR) με οποιαδήποτε θεραπεία κατά την πορεία της νόσου
    -Μετρήσιμη νόσος μόνο βάσει των Ελεύθερων Ελαφρών Αλυσίδων
    -Προηγούμενη θεραπεία με πομαλιδομίδη
    -Οποιαδήποτε φαρμακευτική θεραπεία κατά του μυελώματος εντός 14 ημερών πριν από την τυχαιοποίηση, συμπεριλαμβανομένης της δεξαμεθαζόνης
    -Κατάσταση κατά ECOG >2
    -Αιμοπετάλια <75.000 κύτταρα/μL εάν <50% των εμπύρηνων κυττάρων του μυελού των οστών (BM) είναι πλασματοκύτταρα και <30.000 κύτταρα/μL εάν ≥50% των εμπύρηνων κυττάρων του BM είναι πλασματοκύτταρα. Η μετάγγιση αιμοπεταλίων δεν επιτρέπεται εντός τριών ημερών πριν από την αιματολογική εξέταση προκαταρκτικής αξιολόγησης
    -ANC <1.000 μ/L (1 x 109/L). Η χρήση G-CSF δεν επιτρέπεται να φτάσει αυτό το επίπεδο
    -Κάθαρση κρεατινίνης <30 mL/min (Τύπος MDRD)
    -Ολική χολερυθρίνη >2 x ULN
    -Διορθωμένο ασβέστιο ορού >14 mg/dL (>3,5 mmol/L)
    -AST και/ή ALT>3 x ULN
    -Υπερευαισθησία σε IMiD (θαλιδομίδη ή λεναλιδομίδη) που ορίζεται ως οποιαδήποτε αντίδραση υπερευαισθησίας που οδηγεί στη διακοπή των IMiD εντός των 2 πρώτων κύκλων ή τοξικότητα που δεν πληροί τον ορισμό της δυσανεξίας
    -Υπερευαισθησία στη δεξαμεθαζόνη, στη σακχαρόζη, στην ιστιδίνη (ως βάση και υδροχλωρικό άλας) και στο πολυσορβικό 80 ή σε οποιοδήποτε από τα συστατικά της θεραπείας της μελέτης που δεν επιδέχονται προκαταρκτική αγωγή με στεροειδή ή H2 αναστολείς, γεγονός που θα απαγόρευε περαιτέρω θεραπεία με αυτούς τους παράγοντες
    -Σημαντική καρδιακή δυσλειτουργία, έμφραγμα του μυοκαρδίου εντός 12 μηνών, ασταθής, ανεπαρκώς ελεγχόμενη στηθάγχη
    -Γυναίκα ασθενής που είναι έγκυος ή θηλάζει ή σκοπεύει να μείνει έγκυος κατά τη διάρκεια της συμμετοχής στη μελέτη.
    -Άνδρες συμμετέχοντες που δεν συμφωνούν να απέχουν πλήρως από τη σεξουαλική επαφή ή δεν συμφωνούν να χρησιμοποιούν προφυλακτικό κατά τη διάρκεια της σεξουαλικής επαφής με έγκυο γυναίκα ή γυναίκα με δυνατότητα τεκνοποίησης κατά τη διάρκεια της συμμετοχής στους στη μελέτη, κατά τη διάρκεια διακοπής των δόσεων και για τουλάχιστον 3 μήνες μετά τη διακοπή της θεραπείας της μελέτης, ακόμα και αν έχουν υποβληθεί σε επιτυχή απολίνωση των σπερματικών πόρων.
    -Όλοι οι ασθενείς που δεν συμφωνούν να απέχουν από τη δωρεά αίματος ενόσω λαμβάνουν τη θεραπεία της μελέτης και για 4 εβδομάδες μετά τη διακοπή αυτής της θεραπείας της μελέτης.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Επιβίωση Χωρίς Εξέλιξη της Νόσου (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessment at screening, then every 4 weeks until progression
    Αξιολόγηση της νόσου στην προκαταρκτική αξιολόγηση (screening) και έπειτα κάθε 4 εβδομάδες έως την πρόοδο της νόσου
    E.5.2Secondary end point(s)
    1/ Overall Response Rate (ORR)
    2/ Overall Survival (OS)
    3/ Time to Progression (TTP)
    4/ Progression Free Survival in high risk cytogenetic population
    5/ Duration of response
    6/ Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling
    7/ Patient-reported outcome measured with Quality of Life questionnaire EORTC-QLQ-C30
    Patient-reported outcome measured with Quality of Life questionnaire MY20
    Patient-reported outcome measured with Quality of Life questionnaire EQ-5D-5L
    8/ Plasma concentrations of isatuximab (IPd Arm)
    9/ Immune response (IPd Arm) : levels of human anti-drug antibodies (ADA)
    1). Συνολικό ποσοστό ανταπόκρισης (ORR)
    2). Ολική επιβίωση (OS)
    3). Χρόνος έως την εξέλιξη της νόσου (TTP)
    4). PFS σε ασθενείς με υψηλό κίνδυνο κυτταρογενετικών μεταβολών
    5). Διάρκεια ανταπόκρισης
    6). Αριθμός ασθενών με ανεπιθύμητα συμβάματα βάσει των κριτηρίων NCI-CTC έκδοση 4.03.
    7). Αναφερόμενες από τον ασθενή εκβάσεις μετρούμενες με το ερωτηματολόγιο Ποιότητας Ζωής EORTC-QLQ-C30
    Αναφερόμενες από τον ασθενή εκβάσεις μετρούμενες με το ερωτηματολόγιο Ποιότητας Ζωής MY20
    Αναφερόμενες από τον ασθενή εκβάσεις μετρούμενες με το ερωτηματολόγιο Ποιότητας Ζωής EQ-5D-5L
    8). Συγκεντρώσεις isatuximab στο πλάσμα (IPd Arm)
    9). Ανοσο – ανταπόκριση (IPd Arm): επίπεδα ανθρώπινων αντισωμάτων έναντι του φαρμάκου (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3-4/ Disease assessment at screening, then every 4 weeks until progression
    2/ Up to date of survival event
    5/ Disease assessment every 4 weeks until progression
    6-8/ Up to 30 days after last study treatment administration
    7/ At screening, then every 4 weeks during study treatment, then 30 and 60 days after last study treatment administration
    9/ Up to 60 days after last study treatment administration, or until test is negative whichever comes last
    1-3-4/ Αξιολόγηση της νόσου στην προκαταρκτική επίσκεψη και έπειτα κάθε 4 εβδομάδες έως την πρόοδο της νόσου
    2/ έως την ημερομηνία κάποιου επεισοδίου επιβίωσης
    5/ Αξιολόγηση της νόσου κάθε 4 εβδομάδες έως την πρόοδο της νόσου
    6-8/ Έως 30 ημέρες μετά την τελευταία χορήγηση της θεραπείας της μελέτης
    7/ Στην προκαταρκτική επίσκεψη, έπειτα κάθε 4 εβδομάδες κατά τη διάρκεια της θεραπείας της μελέτης και έπειτα 30 και 60 ημέρες μετά την τελευταία χορήγηση της θεραπείας της μελέτης
    9/ έως 60 ημέρες μετά την τελευταία χορήγηση της θεραπείας της μελέτης ή έως αρνητικού τεστ, οποιοδήποτε έρθει τελευταίο
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Norway
    Poland
    Portugal
    Russian Federation
    Slovakia
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Τελευταία Επίσκεψη Τελευταίου Ασθενούς
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 300
    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
    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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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