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    Summary
    EudraCT Number:2016-003097-41
    Sponsor's Protocol Code Number:EFC14335
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT 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
    Ensayo clínico en fase III, aleatorizado, abierto y multicéntrico para comparar isatuximab (SAR650984) en combinación con pomalidomida y dosis bajas de dexametasona frente a pomalidomida y dosis bajas de dexametasona en pacientes con mieloma múltiple refractario o recidivante y refractario
    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
    Ensayo clínico multinacional que compara isatuximab, pomalidomida y dexametasona frente a pomalidomida y dexametasona en pacientes con mieloma múltiple refractario o recidivante y refractario.
    A.3.2Name or abbreviated title of the trial where available
    ICARIA-MM
    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, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@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
    Enfermedad hemato-oncológica
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Cáncer hematológico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level 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).
    Demostrar el beneficio de isatuximab en combinación con pomalidomida y dosis bajas de dexametasona en la prolongación de la supervivencia libre de progresión (SLP) respecto de pomalidomida y dosis bajas de dexametasona en pacientes con mieloma múltiple (MM) refractario o recidivante y refractario.
    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.
    - Evaluar la Tasa De Respuesta Global (TRG) según los criterios del Grupo de Trabajo Internacional sobre Mieloma (IMWG) en cada brazo.
    - Comparar la Supervivencia Global (SG) entre ambos grupos.
    - Evaluar el Tiempo hasta la Progresión (THP) en cada grupo.
    - Evaluar la SLP en la población con alto riesgo citogenético en cada grupo.
    - Evaluar la Duración de la Respuesta (DR) en cada grupo.
    - Evaluar la seguridad en los dos grupos de tratamiento.
    - Determinar el perfil farmacocinético (FC) de isatuximab en combinación con pomalidomida.
    - Evaluar la inmunogenicidad de isatuximab.
    - Evaluar la calidad de vida relacionada con la salud (CVRS) específica para la enfermedad y general, los síntomas asociados a la enfermedad y al tratamiento, la utilidad del estado de salud y el estado de salud.
    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.
    I 01. Superior o igual a18 años de edad, o mayor de edad en los países en los que la mayoría de edad legal es superior a 18 años.
    I 02. Diagnóstico documentado de mieloma múltiple con evidencia de enfermedad medible: proteína M en suero ≥0,5 g/dl medida mediante inmunoelectroforesis de proteínas séricas; o proteína M en orina ≥ 200 mg/24 horas medida mediante inmunoelectroforesis de proteínas en orina.
    I 03. Los pacientes deben haber recibido al menos dos líneas previas de tratamiento antimieloma, que deben incluir al menos dos ciclos consecutivos de lenalidomida y un inhibidor del proteasoma (bortezomib, carfilzomib o ixazomib) administrados en monoterapia o en combinación.
    I 04. Los pacientes deben haber tenido un fracaso del tratamiento con lenalidomida o un inhibidor del proteasoma (bortezomib, carfilzomib o ixazomib) en monoterapia o en combinación,
    I 05. Los pacientes deben haber sufrido progresión mientras recibían el último tratamiento previo a la entrada en el estudio o en los 60 días siguientes al fin del mismo, es decir, pacientes refractarios a la última línea de tratamiento.
    I 06. El paciente ha otorgado su consentimiento voluntario por escrito antes de la realización de ningún procedimiento relacionado con el estudio que no forme parte de la atención médica habitual, y ha comprendido que puede retirar su consentimiento en cualquier momento sin que esto afecte a su atención médica.
    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.
    Mieloma múltiple primario refractario, definido como: pacientes que nunca han presentado ni siquiera una respuesta mínima (RM) a ningún tratamiento durante el curso de la enfermedad.
    Enfermedad medible únicamente por las cadenas ligeras libres.
    Tratamiento previo con pomalidomida.
    Cualquier tratamiento con un fármaco antimieloma en los 14 días anteriores a la aleatorización, incluida dexametasona.
    Estado ECOG >2
    Plaquetas <75 000 células/µl si <50 % de las células nucleadas de la médula ósea (MO) son células plasmáticas y <30 000 células/µl si ≥50 % de las células nucleadas de la MO son células plasmáticas. No está permitida la transfusión de plaquetas en los tres días anteriores al análisis hematológico de la selección.
    RAN <1000 μ/l (1 x 109/l). No se permite el uso de G-CSF para alcanzar este nivel.
    Aclaramiento de creatinina (AcCr) <30 ml/min (fórmula MDER, véase el Apéndice A).
    Bilirrubina total >2 veces el LSN.i
    Calcio sérico corregido >14 mg/dl (>3,5 mmol/l).
    AST o ALT>3 veces el LSN.
    Hipersensibilidad a los FIM (talidomida o lenalidomida), definida como cualquier reacción de hipersensibilidad que cause la interrupción del tratamiento con FIM durante los 2 primeros ciclos o toxicidad y que no cumpla con la definición de intolerancia (véase I04).
    Hipersensibilidad a dexametasona, sacarosa, histidina (como base y sal de hidrocloruro) y polisorbato 80 o a cualquiera de los componentes del tratamiento del estudio no susceptibles de premedicación con esteroides o bloqueantes H2 que prohíba el tratamiento posterior con estos fármacos.
    Disfunción cardiaca importante, infarto de miocardio en los 12 meses anteriores, angina de pecho inestable mal controlada.
    Mujeres embarazadas o en periodo de lactancia, o mujeres que planean quedarse embarazadas durante el estudio
    Participantes varones que no acepten practicar abstinencia sexual total o usar un preservativo durante el contacto sexual con una mujer con capacidad de concebir o una mujer en edad fértil mientras participen en el estudio, durante las interrupciones de la administración y durante al menos 3 meses tras la última administración del tratamiento del estudio, aunque se hayan sometido con éxito a una vasectomía.
    Cualquier paciente que no acepte abstenerse de donar sangre mientras permanezca en el estudio y durante las 4 semanas siguientes a la última dosis del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Supervivencia libre de progresión (SLP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessment at screening, then every 4 weeks until progression
    Evaluación de la enfermedad en la selección, y cada 4 semanas hasta la progresión
    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 / Tasa de respuesta global (ORR)
    2 / Supervivencia global (OS)
    3 / Tiempo hasta la progresión (TTP)
    4 / Supervivencia libre de progresión (SLP) en población citogenética de alto riesgo
    5 / Duración de la respuesta
    6 / Número de pacientes con acontecimientos adversos según el Instituto Nacional del Cáncer - Criterios comunes de toxicidad (NCI-CTC) versión 4.03 escala de grado
    7 / Resultado informado por el paciente medido con el cuestionario de calidad de vida EORTC-QLQ-C30
    Resultado del paciente medido con el cuestionario de calidad de vida MY20
    Resultado del paciente medido con el cuestionario de Calidad de Vida EQ-5D-5L
    8 / Las concentraciones plasmáticas de isatuximab (IPd Arm)
    9 / Respuesta inmune (IPd Arm): niveles de anticuerpos anti-fármaco humanos (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 / Evaluación de la enfermedad en la selección, luego cada 4 semanas hasta la progresión
    2 / Hasta la fecha del evento de supervivencia
    5 / Evaluación de la enfermedad cada 4 semanas hasta la progresión
    6-8 / Hasta 30 días después de la última administración del tratamiento del estudio
    7 / En la selección, luego cada 4 semanas durante el tratamiento del estudio, luego 30 y 60 días después de la última administración del tratamiento del estudio
    9 / Hasta 60 días después de la última administración del tratamiento, o hasta que la prueba sea negativa, cualquiera que sea la última
    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) Yes
    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 concerned6
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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 state14
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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