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    Summary
    EudraCT Number:2015-002509-13
    Sponsor's Protocol Code Number:3475-183
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-11-03
    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 number2015-002509-13
    A.3Full title of the trial
    A phase III study of Pomalidomide and low dose Dexamethasone with or without Pembrolizumab (MK3475) in refractory or relapsed and refractory Multiple Myeloma (rrMM) (KEYNOTE 183)
    Estudio en fase III de pomalidomida y dexametasona en dosis baja con o sin pembrolizumab (MK3475) en el mieloma múltiple resistente o recidivante y resistente (MMrr). (KEYNOTE 183)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in refractory or relapsed and refractory Multiple Myeloma (rrMM).
    Estudio en fase III de pomalidomida y dexametasona con o sin pembrolizumab en el mieloma múltiple resistente o recidivante y resistente (MMrr).
    A.3.2Name or abbreviated title of the trial where available
    A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in rrMM
    Estudio en fase III de pomalidomida y dexametasona con o sin pembrolizumab en el MMrr
    A.4.1Sponsor's protocol code number3475-183
    A.5.4Other Identifiers
    Name:IND No:Number:118604
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    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 RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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
    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.3.9.3Other descriptive namePomalidomide
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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
    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.3.9.3Other descriptive namePomalidomide
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.9.3Other descriptive namePomalidomide
    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 RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.9.3Other descriptive namePomalidomide
    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.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
    Patients with refractory or relapsed and refractory multiple myeloma (rrMM) who have failed at least 2 lines of prior treatment and have been previously exposed to an immunomodulatory drug (IMiDs) as lenalidomide or thalidomide and a proteasome inhibitor as bortezomib or carfilzomib.
    Pacientes con mieloma múltiple resistente o recidivante y resistente (MMrr) que hayan recibido al menos 2 líneas de tratamiento previo, sean resistentes a la última línea de tratamiento y hayan estado expuestos anteriormente a un fármaco inmunomodulador (FIM), como lenalidomida o talidomida, y un inhibidor del proteasoma, como bortezomib o carfilzomib.
    E.1.1.1Medical condition in easily understood language
    Patients with multiple myeloma that has progressed after receaving at least 2 lines of prior treatment. These treatments must have included lenalidomide or thalidomide and a proteasome inhibitor.
    Pacientes con mieloma múltiple cuya enfermedad haya progresado y hayan recibido 2 líneas de tratamiento previo. Estos tratamientos deben incluir lenalidomida o talidomida y un inhibidor del proteasoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the Progression Free Survival (PFS) as assessed by CAC blinded central review according to the International Myeloma Working Group response criteria, (IMWG criteria) between treatment arms.
    Comparar la supervivencia sin progresión (SSP), evaluada mediante la revisión central enmascarada del CVC (Comité de Vigilancia de los datos), según los criterios de respuesta del International Myeloma Working Group (criterios del IMWG [1]) entre los grupos de tratamiento.
    E.2.2Secondary objectives of the trial
    (1) Objective: Compare the Overall Survival (OS).
    (2) Objective: Evaluate Overall Response Rate (ORR) and Disease Control Rate (DCR) as assessed by CAC blinded central review using IMWG criteria [1] or EBMT criteria for minor response only and Duration of Response (DOR) as assessed by CAC blinded central review using IMWG criteria
    (3) Objective: To evaluate the safety and tolerability in both treatment arms.
    (1)Objetivo: Comparar la supervivencia global (SG).
    (2)Objetivo: Determinar la tasa de respuestas globales (TRG) y la tasa de control de la enfermedad (TCE) según la revisión central enmascarada del CVC aplicando los criterios del IMWG o solo los criterios del EBMT para la respuesta menor y la duración de la respuesta (DR) según la revisión central enmascarada del CVC aplicando los criterios del IMWG
    (3)Objetivo: Evaluar la seguridad y tolerabilidad en ambos grupos de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck llevará a cabo investigaciones biomédicas futuras con las
    muestras obtenidas específicamente con estos fines durante este ensayo
    clínico. Estas investigaciones tendrán por objeto el análisis de
    biomarcadores para abordar aspectos nuevos que no se describen en
    otras partes del protocolo (como parte del ensayo principal) y solo se
    llevarán a cabo en muestras de los sujetos que hayan otorgado el
    consentimiento correspondiente. El objetivo de la obtención de muestras
    para investigaciones biomédicas futuras consiste en estudiar e
    identificar biomarcadores que proporcionen información a los científicos
    sobre las enfermedades y sus tratamientos. El objetivo último es utilizar
    tal información para desarrollar fármacos más seguros y eficaces y/o
    para garantizar que los pacientes reciban la dosis correcta del fármaco
    adecuado en el momento preciso.
    E.3Principal inclusion criteria
    1.Must have undergone prior treatment with > or = to 2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment defined as documented disease progression during or within 60 days of completing their last anti-myeloma therapy (refractory to last line of treatment).
    2.Prior anti-myeloma treatments must have included an IMiD (lenalidomide or thalidomide) AND proteasome inhibitor (bortezomib or carfilzomib) alone or in combination and subject must have failed therapy with an IMiD OR proteasome inhibitor defined as one of the following:
    a.Refractory: Documented progressive disease on or within 60 days of completing treatment with an IMiD and/or proteasome inhibitor OR
    b. Relapsed and refractory: In case of prior response [> or = to partial response (PR)] to an IMiD or proteasome inhibitor, subjects must have relapsed within 6 months after stopping treatment with and IMiD and/or proteasome inhibitor containing regimens
    3.Confirmed diagnosis of active MM and measurable disease defined as:
    ?Serum monoclonal protein (M-protein) levels > or = to 0.5 g/dL or
    ?Urine monoclonal protein (M-protein) levels > or = to 200 mg/24-hours or
    ?Subjects without measurable serum and urine M-protein levels, an abnormal serum free light chain ratio (FLC ?/?) with involved FLC level > or = to 100 mg/L. (Normal serum FLC ?/? value: 0.26 - 1.65)
    ?Presence of CRAB features
    4.Provide, archival (< or = to 60 days) or newly obtained bone marrow biopsy or aspirate material for disease assessment and biomarker analysis.
    5.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
    1.Deben haber recibido anteriormente > o = a 2 líneas de tratamiento antimieloma y no deben haber respondido a su última línea, definiendo la falta de respuesta como progresión documentada de la enfermedad durante su último tratamiento frente al mieloma o en los 60 días siguientes (resistente a la última línea de tratamiento).
    2.Los tratamientos previos contra el mieloma deben haber consistido en un FIM (lenalidomida o talidomida) Y un inhibidor del proteasoma (bortezomib o carfilzomib) solos o en combinación , y el paciente no debe haber respondido al tratamiento con un FIM O un inhibidor del proteasoma, definiendo la falta de respuesta como una de las circunstancias siguientes:
    a.Resistente: Progresión documentada de la enfermedad al finalizar el tratamiento con un FIM y/o un inhibidor del proteasoma o en los 60 días posteriores, O
    b.Recidivante y resistente: En caso de respuesta previa [> o = a respuesta parcial (RP)] a un FIM o inhibidor del proteasoma, los pacientes deben presentar una recidiva en los 6 meses siguientes a la suspensión del tratamiento con pautas que contengan FIM y/o inhibidores del proteasoma
    3.Deberán tener un diagnóstico confirmado de mieloma múltiple activo y enfermedad mensurable, definida de la manera siguiente:
    a.Concentraciones séricas de proteína monoclonal (proteína M) > o = a 0,5 g/dl o
    b.Concentraciones urinarias de proteína monoclonal (proteína M) > o = a 200 mg/ 24 horas o
    c.en los pacientes sin concentraciones mensurables de proteína M en el suero y la orina, un índice anormal de cadenas ligeras libres en suero (CLL ?/?) con una concentración de CLL afectadas > o = a 100 mg/l. (Valor normal de CLL ?/? en suero: 0,26 - 1,65).
    d.Presencia de características CRAB del mieloma
    4.Deberán ser capaces de proporcionar muestras de archivo (< o = a 60 días) o recién obtenidas de biopsia o aspirado de médula ósea para evaluación de la enfermedad y análisis de biomarcadores en la selección.
    5.Tienen que presentar un estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
    E.4Principal exclusion criteria
    1.Subjects with non-secretory or oligo-secretory myeloma, smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukemia or Waldenström's macroglobulinemia.
    2.History of repeated infections, primary amyloidosis, hyperviscosity or POEMS syndrome.
    3.Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. < or = to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    4.Has had prior anti-myeloma therapy including but not limited to dexamethasone, IMiDs, proteasome inhibitors, chemotherapy, or radiation therapy within 2 weeks prior to Study Day 1 who has not recovered (i.e. ? Grade 1 or at baseline) from adverse events due to a previously administered agent.
    5.Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease (GVHD).
    6.Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or are planning for or are eligible for auto-SCT.
    7.Has known hypersensitivity to thalidomide, lenalidomide or dexamethasone.
    8.Has received previous therapy with pomalidomide.
    9.Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
    10.Subjects with peripheral neuropathy > or = to Grade 2.
    11.Has evidence of active, non-infectious pneumonitis.
    12.Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
    1.Pacientes con mieloma no secretor u oligosecretor, mieloma múltiple asintomático (MMA), gammapatía monoclonal de importancia indeterminada (GMII), leucemia de de células plasmáticas o macroglobulinemia de Waldenström
    2.Antecedentes de infecciones repetidas, amiloidosis primaria, hiperviscosidad o síndrome POEMS
    3.Recepción de un anticuerpo monoclonal en las 4 semanas previas al día 1 del estudio o ausencia de recuperación (es decir, a un grado < o = a 1 o al nivel basal) de los acontecimientos adversos provocados por los fármacos administrados más de 4 semanas antes.
    4.Tratamiento antimieloma previo, por ejemplo, dexametasona, FIM, inhibidores del proteasoma, quimioterapia o radioterapia en las 2 semanas previas al día 1 del estudio y ausencia de recuperación (es decir, a un grado < o = a 1 o al nivel basal) de los acontecimientos adversos provocados por un medicamento administrado anteriormente
    5.Alotrasplante de células progenitoras hematopoyéticas en los 5 años precedentes. (Si el trasplante se realizó más de 5 años antes, el paciente podrá participar siempre que no presente síntomas de enfermedad de injerto contra huésped [EICH]).
    6.Autotrasplante de células progenitoras (auto-TCP) en las 12 semanas previas a la primera infusión o previsión o idoneidad para un auto-TCP.
    7.Hipersensibilidad conocida a talidomida, lenalidomida o dexametasona.
    8.Tratamiento previo con pomalidomida.
    9.Incapacidad para someterse a una profilaxis tromboembólica
    10.Neuropatía periférica > o = a grado 2.
    11.Indicios de neumonitis no infecciosa activa.
    12.Tratamiento previo con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti-CTLA-4
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study is Progression-free survival (PFS) ? the International Myeloma Working Group response criteria (IMWG 2006) by blinded central review.
    PFS is defined as the time from randomization to the first documented disease progression per IMWG 2006 based on blinded central review or death due to any cause, whichever occurs first.
    El criterio de valoración principal de este estudio es la Supervivencia sin progresión (SSP) - los criterios de respuesta del International Myeloma Working Group (IMWG de 2006) según la revisión central enmascarada del CVC
    La SSP se define como el tiempo transcurrido entre la aleatorización y la primera progresión documentada de la enfermedad conforme a los criterios del IMWG de 2006 según la revisión central enmascarada del CVC o la muerte por cualquier causa, lo que ocurra antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.PFS Analysis/First OS Analysis: ~ 20 months after trial starts (when all subjects are enrolled, 230 PFS events and ~123 OS events are observed).
    1. SSP Análisis/ Primer SG análisis: Aprox. 20 meses después del comienzo del ensayo (Cuando todos los sujetos hayan sido reclutados, 230 eventos de SSP y aprox. 123 eventos de SG se hayan observado)
    E.5.2Secondary end point(s)
    1.Compare the Overall Survival (OS).
    2.Evaluate Overall Response Rate (ORR) and Disease Control Rate (DCR) as assessed by CAC blinded central review and as per investigator assessment using IMWG criteria or EBMT criteria for minor response only and Duration of Response (DOR) as assessed by CAC blinded central review and as per investigator assessment using IMWG criteria
    3.To evaluate the safety and tolerability in both treatment arms.
    1.Comparar la supervivencia global (SG).
    2. Determinar la tasa de respuestas globales (TRG) y la tasa de control de la enfermedad (TCE) según la revisión central enmascarada del CVC aplicando los criterios del IMWG o solo los criterios del EBMT para la respuesta menor y la duración de la respuesta (DR) según la revisión central enmascarada del CVC aplicando los criterios del IMWG
    3. Evaluar la seguridad y tolerabilidad en ambos grupos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.An interim safety analysis will take place after 15 subjects in each treatment arm have completed 1 cycle of therapy.
    2.Final OS Analysis: ~ 10 mos after main PFS analysis or ~ 185 OS events, whichever comes first.
    1. Será realizado un análisis intermedio de seguridad después de que 15 pacientes hayan completado un ciclo de tratamiento en cada rama.
    2. Análisis final de SG: aprox. 10 meses después del primer análisis de SSP o aprox. cuando hayan ocurrido 185 eventos de SG, lo que ocurra primero.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    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)
    Standard of Care.
    Practica clínica habitual
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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