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    Summary
    EudraCT Number:2019-001169-34
    Sponsor's Protocol Code Number:20180117
    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:2020-05-15
    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 number2019-001169-34
    A.3Full title of the trial
    An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
    Estudio de fase 2 abierto de sujetos con mieloma multiple en primera o segunda recaida tratados con carfilzomib, pomalidomida y dexametasona (KPd)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
    Estudio de evaluacion del tratamiento del mieloma multiple con carfilzomib en combinacion con pomalidomida y dexametasona
    A.4.1Sponsor's protocol code number20180117
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona, s/n, Edifici Sud 7a planta
    B.5.3.2Town/ cityBarceñpma
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number34936001860
    B.5.6E-mailinformacion.medica.es@amgen.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 Yes
    D.2.1.1.1Trade name Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/548
    D.3 Description of the IMP
    D.3.1Product nameCarfilzomib
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARFILZOMIB
    D.3.9.1CAS number 868540-17-4
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    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.3.9.3Other descriptive namePOMALIDOMIDE
    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
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    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.3.9.3Other descriptive namePOMALIDOMIDE
    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
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    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.3.9.3Other descriptive namePOMALIDOMIDE
    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
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    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.3.9.3Other descriptive namePOMALIDOMIDE
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed multiple myeloma
    Mieloma multiple en recaida
    E.1.1.1Medical condition in easily understood language
    a cancer that affects some of your immune cells and affects how your normal blood cells
    Un cáncer que afecta algunas de las células inmunitarias y células sanguíneas normales
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the efficacy by rate of minimal residual disease negative (MRD[-]) response of carfilzomib in combination with pomalidomide and dexamethasone (KPd) in subjects with multiple myeloma at first or second relapse after treatment with lenalidomide and daratumumab at 12 months landmark.
    Estimar la eficacia segun la tasa de respuesta de enfermedad minima residual negativa (EMR[-]) de carfilzomib en combinacion con pomalidomida y dexametasona (KPd) en sujetos con mieloma multiple en primera o segunda recaida despues del tratamiento con lenalidomida y daratumumab a los 12 meses como referencia.
    E.2.2Secondary objectives of the trial
    • Describe the safety and tolerability of carfilzomib combined with dexamethasone and pomalidomide
    • Estimate the frequency of best MRD[-] response in KPd
    • Estimate the frequency of sustained MRD[-] response
    • Estimate the frequency of sustained MRD[-] response at landmark 24 months
    • Estimate the overall response rate (ORR)
    • Estimate ORR at 12 months landmark
    • Estimate duration of response, time to response, progression-free survival (PFS), and overall survival (OS)
    • Estimate CR rate
    •Describir la seguridad y tolerabilidad de carfilzomib en combinacion con dexametasona y pomalidomida.
    •Estimar la frecuencia de la mejor respuesta de EMR[-] con KPd.
    •Estimar la frecuencia de la respuesta de EMR[-] sostenida.
    •Estimar la frecuencia de respuesta de EMR[-] sostenida a los 24 meses como referencia.
    •Estimar la tasa de respuesta global (TRG).
    •Estimar la TRG a los 12 meses como referencia.
    •Estimar la duracion de la respuesta, el tiempo de respuesta, la supervivencia libre de progresion (SLP) y la supervivencia global (SG).
    •Estimar la tasa de RC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subjects are eligible to be included in the study only if all of the following criteria apply:
    -Male or female subjects age ≥ 18 years
    -First or second relapse of multiple myeloma
    -Must be Refractory to lenalidomide
    -Prior treatment includes completion of at least 2 consecutive cycles of daratumumab
    -Measurable disease with at least 1 of the following assessed within 21 days prior to enrollment:
    •IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
    •IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL
    •urine M-protein ≥ 200 mg per 24 hours
    •in subjects without measurable serum or urine M-protein, serum-free light
    •chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
    -Must have at least a partial response (PR) to at least 1 line of prior therapy
    -Prior therapy with PI is allowed. Subjects receiving prior carfilzomib therapy must have achieved at least a PR, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval from their last dose of carfilzomib
    -Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
    Los sujetos son elegibles para ser incluidos en el estudio solo si cumplen todos los criterios siguientes:
    -Hombre o mujer ≥ 18 anos de edad.
    -Mieloma multiple en primera o segunda recaida
    -Ser refractario a lenalidomida.
    -El tratamiento previo incluye el haber completado al menos 2 ciclos consecutivos de daratumumab.
    -Enfermedad medible con al menos 1 de los siguientes parametros evaluados durante los 21 dias previos a la inclusion:
    •Mieloma multiple de tipo IgG: nivel de proteina monoclonal (proteina M) en suero ≥ 1,0 g/dl.
    •Mieloma multiple de tipo IgA, IgD, IgE: nivel de proteina M en suero ≥ 0,5 g/dl.
    •Proteina M en orina ≥ 200 mg en 24 horas.
    •En sujetos sin proteina M medible en suero u orina, cadena ligera libre en suero (SFLC) ≥ 100 mg/l (cadena ligera afectada) y una proporcion kappa lambda anormal en suero.
    •Los sujetos deben tener como minimo una respuesta parcial (RP) a al menos 1 línea de tratamiento previa.
    •Se permite el tratamiento previo con un IP. Los sujetos que reciban tratamiento previo con carfilzomib deben haber alcanzado al menos una RP, no deben haber sido retirados debido a toxicidad, no deben haber sufrido una recaida durante los 60 dias posteriores a la interrupcion del tratamiento con carfilzomib y no deben haber recibido tratamiento con carfilzomib durante al menos un intervalo de 6 meses desde la ultima dosis de carfilzomib.
    •Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 a 2
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria apply:
    Disease Related
    - Primary refractory multiple myeloma
    -Waldenström macroglobulinemia
    - Multiple myeloma of IgM subtype
    -POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
    -Plasma cell leukemia
    -Primary amyloidosis
    -Previous diagnosis of amyloidosis associated with myeloma
    -Myelodysplastic syndrome
    -Toxicity requiring discontinuation of lenalidomide therapy
    -Prior treatment with pomalidomide
    Other Medical Conditions
    - History of other malignancy within the past 3 years,
    - Active HBV infection.
    -HIV infection, hepatitis C infection
    -Presence of graft-versus-host disease including continuation of immunosuppressive therapy despite resolution of graft-versus-host disease
    -Known cirrhosis
    - Uncontrolled hypertension, defined as an average systolic blood pressure
    - Active congestive heart failure
    -Intolerance to hydration due to pre-existing pulmonary or cardiac impairment
    -History of interstitial lung disease or ongoing interstitial lung disease
    -Active infection within 14 days prior to enrollment requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents.
    - Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to enrollment
    -Known pulmonary hypertension
    -Pleural effusions requiring thoracentesis or ascites requiring paracentesis within14 days prior to enrollment
    Prior/Concomitant Therapy
    -Immunotherapy with potential antimyeloma activity within 21 days prior to enrollment
    -Monoclonal antibody therapy within 21 days prior to enrollment
    -Chemotherapy with approved anticancer therapeutic within 21 days prior to enrollment
    -Plasmapheresis within 21 days prior to enrollment
    -Glucocorticoid therapy within 14 days prior to enrollment that exceeds a
    cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids
    -Focal radiation therapy within 7 days prior to enrollment.
    -Major surgery (except kyphoplasty) within 28 days prior to enrollment
    -Autologous or allogeneic stem cell transplant within 90 days prior to enrollment
    Los sujetos son excluidos del estudio si cumplen alguno de los criterios siguientes:
    Relacionados con la enfermedad
    -Mieloma multiple refractario primario.
    -Macroglobulinemia de Waldenstrom.
    -Mieloma multiple de subtipo IgM.
    -Sindrome de POEMS (polineuropatia, organomegalia, endocrinopatia, proteina monoclonal y alteraciones cutaneas).
    -Leucemia de celulas plasmaticas
    -Amiloidosis primaria
    -Diagnostico previo de amiloidosis asociada al mieloma.
    -Sindrome mielodisplasico.
    -Toxicidad que requiera la interrupcion del tratamiento con lenalidomida.
    -Tratamiento previo con pomalidomida.
    -Otras enfermedades
    -Antecedentes de otras neoplasias malignas en los ultimos 3 años
    - Infección activa por el virus de la hepatitis B (VHB)
    -Infeccion conocida por el VIH, infeccion por hepatitis C
    -Presencia de la enfermedad del injerto contra el huesped que incluya la continuacion del tratamiento inmunosupresor a pesar de la resolucion de la enfermedad del injerto contra el huesped.
    -Cirrosis conocida.
    -Hipertension no controlada, definida como un promedio de la presion arterial
    Sistolica
    -Insuficiencia cardiaca congestiva activa
    -Intolerancia a la hidratacion debido a un deterioro pulmonar o cardiaco ya
    existente.
    -Antecedentes de enfermedad pulmonar intersticial o enfermedad pulmonar
    intersticial en curso.
    -Infeccion activa que requiera antibioticos sistemicos, agentes antiviricos (salvo tratamiento antivirico destinado a la hepatitis B) o antifungicos en los 14 dias previos a la inclusion. Dicha infeccion debe desaparecer por completo antes de comenzar el tratamiento en estudio.
    -Neuropatia significativa (grados 3 a 4 o grado 2 con dolor) en los 14 dias previos a la inclusion.
    -Hipertension pulmonar conocida.
    -Derrames pleurales que requieran toracocentesis o ascitis que requiera paracentesis en los 14 dias previos a la inclusion.
    Tratamiento previo/concomitante
    -Inmunoterapia con posible actividad antimieloma en los 21 dias previos a la inclusion.
    -Tratamiento con anticuerpos monoclonales en los 21 dias previos a la inclusion.
    -Quimioterapia con un agente terapeutico anticanceroso aprobado en los 21 dias previos a la inclusion.
    -Plasmaferesis en los 21 dias previos a la inclusion.
    -Tratamiento con glucocorticoides en los 14 dias previos a la inclusion que supere una dosis acumulada de 160 mg de dexametasona o una dosis equivalente de otros corticosteroides.
    -Radioterapia focal en los 7 dias previos a la inclusion.
    - Cirugia mayor (salvo cifoplastia) en los 28 dias previos a la inclusion.
    -Trasplante autologo o alogenico de celulas progenitoras en los 90 dias previos a la inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    • minimal residual disease (MRD) response at a sensitivity of 10-5 using next generation sequencing (NGS)-based method in the bone marrow at 12 months ± 2 weeks from start of treatment
    •Respuesta de enfermedad minima residual (EMR) con una sensibilidad de 10-5 evaluada mediante el metodo basado en la secuenciacion de nueva generacion (NGS) en la medula osea a los 12 meses ± 2 semanas despues del inicio del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be triggered after all subjects have had the opportunity to complete their 12 months landmark MRD assessments.
    El análisis principal se realizará después de que todos los sujetos hayan tenido la oportunidad de completar sus evaluaciones de EMR a los 12 meses como referencia.
    E.5.2Secondary end point(s)
    • subject incidence of treatment-emergent adverse events
    • MRD[-] response at a sensitivity of 10-5 using NGS-based method in the bone marrow at any time during therapy
    • sustained MRD[-] response at a sensitivity of 10-5 using NGS based method in the bone marrow defined as subjects that maintain MRD[-] 12 months or more after achieving MRD[-] status, disregarding when the first MRD[-] was reached.
    • sustained MRD[-] response at a sensitivity of 10-5 using NGS based method in the bone marrow at 24 months ± 2 weeks from start of treatment and calculated only within the subjects who reached MRD[-] in the time window for primary endpoint assessment
    • overall response defined as the best overall confirmed response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) by Independent Review Committee (IRC) per International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
    • landmark overall response by 12 months, defined as the best overall confirmed response of PR, VGPR, CR or sCR by 12 months from start of treatment
    • duration of response, defined as time from first date of PR or better to date of disease progression or death due to any cause
    • time to response, defined as time from start of treatment to first date of PR or better
    • PFS defined as time from start of treatment until progression or death from any cause
    • OS, defined as time from start of treatment until death from any
    cause
    • best overall confirmed response of CR or better
    •Incidencia en los sujetos de acontecimientos adversos que aparecen durante el tratamiento.
    •Respuesta de EMR[-] con una sensibilidad de 10-5 mediante el metodo basado en la NGS en la medula osea en cualquier momento durante el tratamiento.
    •Respuesta de EMR[-] sostenida con una sensibilidad de 10-5 mediante elmétodo basado en la NGS en la médula ósea, definida como los sujetos que mantienen la EMR[-] 12 meses o mas despues de alcanzar el estado de EMR[-],independientemente del momento en que se alcanzara la primera EMR[-].
    •Respuesta de EMR[-] sostenida con una sensibilidad de 10-5 mediante el método basado en la NGS en la médula ósea a los 24 meses ± 2 semanas desde el inicio del tratamiento y calculada solo en los sujetos que alcanzaron la EMR[-] dentro del margen de tiempo de evaluación de la variable principal.
    •Respuesta global, definida como la mejor respuesta global confirmada de respuesta parcial (RP), respuesta parcial muy buena (RPMB), respuesta completa (RC) o respuesta completa estricta (RCe) por el comité de revisión independiente (CRI) según los criterios de respuesta uniforme del Grupo de Trabajo Internacional del Mieloma (IMWG-URC).
    •Respuesta global de referencia a los 12 meses, definida como la mejor respuesta global confirmada de RP, RPMB, RC o RCe a los 12 meses desde el inicio del tratamiento.
    •Duracion de la respuesta, definida como el tiempo desde la primera fecha de RP o mejor hasta la fecha de progresion de la enfermedad o la muerte por cualquier causa.
    •Tiempo hasta la respuesta, definido como el tiempo desde el inicio del tratamiento hasta la primera fecha de RP o mejor.
    •SLP, definida como el tiempo desde el inicio del tratamiento hasta la progresion de la enfermedad o la muerte por cualquier causa.
    •SG, definida como el tiempo desde el inicio del tratamiento hasta la muerte por cualquier causa.
    •La mejor respuesta global confirmada de RC o mejor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be triggered after all subjects have had the opportunity to complete their 12 months landmark MRD assessments.
    -A durable MRD analysis is planned after all subjects have had the opportunity to complete their 24 months landmark MRD assessments.
    -The final analysis is planned after all subjects in have had the opportunity to complete their end of study visit.
    -El análisis principal se realizará después de que todos los sujetos hayan tenido la oportunidad de completar sus evaluaciones de EMR a los 12 meses como referencia.
    -Se planea un análisis duradero de EMR después de que todos los sujetos hayan tenido la oportunidad de completar sus evaluaciones de MRD a los 24 meses como referencia.
    -El análisis final está planeado después de que todos los sujetos hayan tenido la oportunidad de completar su visita final de estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention.
    La fecha de fin del estudio se define como la fecha de la última evaluación o intervención del ultimo paciente del último centro.
    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 months9
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 85
    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)
    N/A
    N/A
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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