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    Summary
    EudraCT Number:2017-002611-34
    Sponsor's Protocol Code Number:54767414MMY2036
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-09-18
    Trial results View 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 number2017-002611-34
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.
    Estudio aleatorizado, abierto, multicéntrico, multifase de JNJ-63723283, un anticuerpo monoclonal anti PD-1, administrado en combinación con daratumumab comparado con daratumumab solo en sujetos con mieloma múltiple en recaída o refractario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multiphase study assessing the anti-tumor activity and safety of JNJ-63723283 (an Anti-PD-1 monoclonal antibody) administered in combination with daratumumab, compared with daratumumab alone in subjects with relapsed or refractory Multiple Myeloma.
    Estudio aleatorizado, abierto, multicéntrico, multifase de JNJ-63723283, un anticuerpo monoclonal anti PD-1, administrado en combinación con daratumumab comparado con daratumumab solo en sujetos con mieloma múltiple en recaída o refractario.
    A.4.1Sponsor's protocol code number54767414MMY2036
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-63723283
    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 INNNot Assigned
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code HuMax-CD38
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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 or Refractory Multiple Myeloma (MM).
    Mieloma Múltiple en Recaída o Refractario (MM).
    E.1.1.1Medical condition in easily understood language
    Blood cancer formed by malignant plasma cells that develops in the bone marrow and is non-responsive to therapy or relapses following treatment.
    Cáncer de la sangre formado por células plasmáticas malignas que se desarrolla en la médula ósea y no responde al tratamiento o recaídas después del tratamiento.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    Part1 (Safety Run-in): To assess the safety of the combination of JNJ-63723283 and daratumumab.
    Part 2 (Phase 2): To compare the overall response rate (ORR) in subjects treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    Part 3 (Phase 3): To compare progression-free survival (PFS) in subjects treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    Parte 1 (preinclusión de seguridad): Evaluar la seguridad de la combinación de JNJ 63723283 y daratumumab.
    Parte 2 (fase 2): Comparar la tasa de respuesta global (TRG) de los sujetos tratados con JNJ 63723283 en combinación con daratumumab frente a los que reciban solo daratumumab.
    Parte 3 (fase 3): Comparar la supervivencia sin progresión (SSP) de los sujetos tratados con JNJ 63723283 en combinación con daratumumab frente a los que reciban solo daratumumab.
    E.2.2Secondary objectives of the trial
    Phase 2 & Phase 3:
    -To assess the safety of of the combination of JNJ 63723283 and daratumumab.
    -To compare the complete response (CR)/better rate & very good partial response (VGPR)/better rate; duration of response and time to response; the minimal residual disease (MRD)-negative rate of JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    -To evaluate the pharmacokinetic & immunogenicity profile of JNJ-63723283 in combination with daratumumab & the profile of daratumumab alone or in combination with JNJ-63723283.
    -To compare PFS & OS of JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    -To evaluate the ORR & OS.
    -To assess the disease-related symptoms,functioning,quality of life (QOL) and health status by using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) & European Quality of Life 5 Dimensions Questionnaire (EQ-5D-5L).
    F2 y F3:Evaluar la seguridad de la combinación de JNJ 63723283 y daratumumab.Comparar la tasa de respuesta completa (RC) o mejor y la tasa de respuesta parcial muy buena (RPMB) o mejor,la duración de la respuesta y el tiempo hasta la respuesta,y la tasa de negatividad para enfermedad residual mínima (ERM) obtenidas con JNJ 63723283 en combinación con daratumumab frente a daratumumab solo.Evaluar el perfil farmacocinético y de inmunogenicidad de JNJ 63723283 en combinación con daratumumab y perfil de daratumumab solo o en combinación con JNJ 63723283.Comparar la SSP y la SG de JNJ 63723283 en combinación con daratumumab frente a daratumumab solo. Evaluar la TRG y la SG. Evaluar los síntomas relacionados con la enfermedad, la capacidad funcional, la calidad de vida (CdV) y el estado de salud mediante el cuestionario básico de 30 apartados de la Org. Eur. para la Investigación y el Trat. del Cáncer (EORTC QLQ-C30) y el cuestionario europeo de calidad de vida de 5 dimensiones (EQ-5D-5L).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study.
    1. At least 18 years of age.
    2. Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course of treatment for multiple myeloma or have disease that is refractory to both a PI and an IMiD. (For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one.Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one).
    3. Evidence of a response to at least 1 prior treatment regimen.
    4. Documented measurable disease for multiple myeloma at screening as defined by the criteria below:
    -IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -Light chain multiple myeloma without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
    5. Have relapsed or refractory disease at time of enrollment as defined below:
    •Relapsed disease is defined as an initial response to previous treatment, followed by progressive disease (PD) by International Myeloma Working Group (IMWG) criteria >60 days after cessation of treatment.
    •Refractory disease is defined as <25% reduction in M-protein or PD by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
    6. Eastern Cooperative Oncology Group Performance Status (ECOG)performance status score of 0, 1, or 2.
    7. Adequate organ function (bone marrow, liver, renal)
    8. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    9. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    Para poder ser incluido, cada posible participante debe cumplir todos los criterios siguientes.
    1. Tener al menos 18 años.
    2. Haber recibido al menos 3 líneas de tratamiento previas con un inhibidor del proteasoma (IP) y un fármaco inmunomodulador (IMiD) en cualquier orden a lo largo del tratamiento del mieloma múltiple o tener resistencia doble a un IP y a un IMiD. (En el caso de los sujetos que hayan recibido más de un tipo de IP, la enfermedad debe ser resistente al más reciente. De forma semejante, si han recibido más de un tipo de IP, la enfermedad debe ser resistente al más reciente.)
    3. Signos de haber respondido al menos a 1 pauta de tratamiento previa.
    4. Mieloma múltiple comprobado y enfermedad mensurable en el momento de la selección, definido por los criterios siguientes:
    -Mieloma múltiple IgG: Concentración de paraproteína monoclonal (proteína M) en suero ≥1,0 g/dl o concentración de proteína M en orina ≥200 mg/24 horas; o
    -Mieloma múltiple IgA, IgM, IgD o IgE: concentración de proteína M en suero ≥0,5 g/dl o concentración de proteína M en orina ≥200 mg/24 horas; o
    -Mieloma múltiple de cadenas ligeras sin enfermedad mensurable en suero ni en orina: Cadenas ligeras libres de inmunoglobulina en suero ≥10 mg/dl y relación anormal entre las cadenas ligeras kappa y lambda de inmunoglobulinas en suero.
    5. Presentar enfermedad recidivante o resistente en el momento de la selección, según la definición siguiente:
    • La enfermedad recidivante se define por una respuesta inicial a un tratamiento previo, seguida de progresión de la enfermedad (PE) de acuerdo con los criterios del International Myeloma Working Group (IMWG) más de 60 días después de suspender el tratamiento.
    • La enfermedad resistente se define por una disminución <25% de la proteína M o por la presencia de PE de acuerdo con los criterios del IMWG durante el tratamiento previo o ≤60 días después de suspender el tratamiento.
    6. Puntuación de 0, 1 o 2 en el estado funcional del Eastern Cooperative Oncology Group (ECOG).
    7. Función orgánica adecuada (médula ósea, hígado, riñones).
    8. Pacientes dispuestos a respetar las prohibiciones y las restricciones especificadas en este protocolo y capaces de hacerlo.
    9. El paciente debe firmar un documento de consentimiento informado (DCI) que indique que entiende el objetivo del estudio y los procedimientos que exige y que está dispuesto a participar en él.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from the study:
    1. Received any of Anti-CD38 antibody, including daratumumab or Anti-PD-1 and anti-PD-L1 antibodies in the past.
    2. Clinically significant cardiac or pulmonary disease.
    3. Prior diagnosis of autoimmune disease with the exception of subjects:
    - With autoimmune thyroid disease or type 1 diabetes that is well controlled on a stable medication regimen
    - With vitiligo, alopecia, or resolved childhood asthma/atopy
    - With psoriasis not requiring systemic therapy
    - With transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent.
    3. Unresolved Grade 2 or higher toxicity effects from previous treatment with immunotherapy not recovered to Grade ≤1 or baseline.
    4. Received any of the following prescribed medications or therapies within the specified period:
    - Antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, prior to first administration of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment prior to first administration of study drug.
    - An allogenic stem cell transplant (SCT) at any time; or autologous SCT within 12 weeks prior to first administration of study drug.
    - Other investigational agent (including investigational vaccines), participation in another clinical study with therapeutic intent, or used an invasive investigational medical device within 28 days or 5 pharmacokinetic half-lives of the investigational agent (whichever is longer) prior to first administration of study drug.
    - Systemic radiotherapy within 14 days prior to first administration of study drug.
    5. Plans to undergo a stem cell transplant prior to progression of disease on this study.
    6. History of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug
    7. Known or suspected of not being able to comply with the study protocol.
    Se excluirá del estudio a los pacientes que cumplan alguno de los criterios siguientes:
    1. Haber sido tratado previamente con cualquier anticuerpo anti-CD38, incluido daratumumab, o anticuerpos anti-PD-1 y anti-PD-L1.
    2. Cardiopatía o enfermedad pulmonar clínicamente importantes.
    3. Diagnóstico previo de una enfermedad autoinmunitaria, con las siguientes excepciones:
    - Enfermedad tiroidea autoinmunitaria o diabetes de tipo 1 bien controlada con un régimen de tratamiento estable.
    - Vitíligo, alopecia o asma/atopia infantil resuelta.
    - Psoriasis sin necesidad de tratamiento sistémico.
    - Manifestaciones autoinmunitarias transitorias de una enfermedad infecciosa aguda que se resolvió con un tratamiento dirigido al agente infeccioso.
    3. Efectos tóxicos de grado 2 o superior no resueltos del tratamiento previo con inmunoterapia que no se haya recuperado a grado ≤ 1 o basal.
    4. Haber recibido alguno de los siguientes medicamentos o tratamientos prescritos en el período especificado:
    - Tratamiento contra el mieloma en las 2 semanas o 5 semividas farmacocinéticas del tratamiento previas a la primera administración del fármaco del estudio, lo que suponga más tiempo. La única excepción es el uso de urgencia de un ciclo corto de corticosteroides (el equivalente a 40 mg/día de dexametasona durante un máximo de 4 días) como tratamiento paliativo antes de la primera administración del fármaco del estudio.
    - Trasplante de células madre (TCM) alogénico en cualquier momento o TCM autólogo en las 12 semanas anteriores a la primera administración del fármaco del estudio.
    - Otro fármaco en investigación (incluidas las vacunas experimentales), participación en otro estudio clínico con intención terapéutica o uso de un producto sanitario experimental invasivo en los 28 días o 5 semividas farmacocinéticas del producto en investigación (lo que suponga más tiempo) anteriores a la primera administración del fármaco del estudio.
    - Radioterapia sistémica en los 14 días previos a la primera administración del fármaco del estudio.
    5. Previsión de someterse a un trasplante de células madre antes de la progresión de la enfermedad durante este estudio.
    6. Antecedente de una neoplasia maligna (distinta del mieloma múltiple) en los 2 años previos a la primera administración del fármaco del estudio.
    7. Incapacidad confirmada o presunta del paciente para cumplir el protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of adverse events (including dose-limiting toxicities (DLTs) (Part 1 [Safety Run-in] Group)
    2. Overall response rate (ORR; as defined by IMWG response criteria (Part 2 [Phase 2] group)
    3. Progression-free survival (PFS) (Part 3 [Phase 3] group)
    1. Incidencia de acontecimientos adversos (incluidas toxicidades limitantes de la dosis (TLD) (grupo de la parte 1 [preinclusión de seguridad]).
    2. Tasa de respuesta global (TRG, definida según los criterios de respuesta del IMWG (grupo de la parte 2 [fase 2]).
    3. Supervivencia sin progresión (SSP) (grupo de la parte 3 [fase 3]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Evaluation after 6 subjects have received 1 treatment cycle (28 days).
    2. Evaluation after 80 subjects have received at least 4 treatment cycles.
    3. Primary Analysis after 138 PFS events.
    1. Evaluación cuando 6 sujetos hayan recibido 1 ciclo de tratamiento (28 días).
    2. Evaluación cuando 80 sujetos hayan recibido al menos 4 ciclos de tratamiento.
    3. Análisis principal cuando se hayan producido 138 acontecimientos de SSP.
    E.5.2Secondary end point(s)
    Phase2 & Phase 3 Groups:
    1. Incidence of adverse events, including immune-related AEs and infusion-related reactions
    2. Complete response (CR) or better rate (as defined by the IMWG response criteria)
    3. Very good partial response (VGPR) or better rate (as defined by the IMWG response criteria)
    4. Duration of response
    5. Time to response
    6. Progression-free survival (PFS)
    7. Incidence of anti-JNJ-63723283 antibodies
    8. Incidence of anti-daratumumab antibodies
    9. Overall survival (OS)
    10. MRD-negative rate
    11. Serum JNJ-63723283 Concentration (Cmin, Cmax)
    12. Serum daratumumab pharmacokinetic Concentration (Cmin, Cmax)
    Part 3 (Phase 3) Group:
    13. Overall response rate (ORR)
    14. Change from baseline in disease-related symptom scales, functioning scales, and Global Health Status (GHS) scale of the EORTC QLQ-C30, and the utility scale and visual analog scale (VAS) of the EQ-5D-5L
    Grupos de las fases 2 y 3:
    1. Incidencia de acontecimientos adversos, incluidos los AA relacionados con el sistema inmunitario y las reacciones relacionadas con la infusión.
    2. Tasa de respuesta completa (RC) o mejor (definida conforme a los criterios de respuesta del IMWG).
    3. Tasa de respuesta parcial muy buena (RPMB) o mejor (definida conforme a los criterios de respuesta del IMWG).
    4. Duración de la respuesta.
    5. Tiempo hasta la respuesta.
    6. Supervivencia sin progresión (SSP).
    7. Incidencia de anticuerpos anti-JNJ 63723283.
    8. Incidencia de anticuerpos anti-daratumumab.
    9. Supervivencia global (SG).
    10. Tasa de negatividad para ERM.
    11. Concentración sérica de JNJ 63723283 (Cmín, Cmáx.)
    12. Concentración sérica (farmacocinética) de daratumumab (Cmín, Cmáx.)
    Grupo de la parte 3 (fase 3):
    13. Tasa de respuesta global (TRG).
    14. Variación respecto al valor basal de las escalas de síntomas relacionados con la enfermedad, escalas de capacidad funcional y escala de estado de salud general (GHS) del QLQ-C30 de la EORTC, y de la escala de utilidad y escala analógica visual (EAV) del EQ-5D-5L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After 50 subjects have been enrolled and have been treated for at least 8 weeks or discontinued the study treatment
    2 to 8. Part 2: At 12 months; Part 3: At 138 events
    9. Part 2: At 12 months; Part 3: After 205 deaths have been observed
    10. At the time of disease progression & at every 6 months in subjects with maintained CR & stringent complete response (sCR)
    11. Cycle (C)1 Day (D)1, C1 D2, D1 of C 2,3,5, 7,12,16 & 24; every 12 cycles thereafter until end of treatment (EOT)
    12. C1 D1, C1 D2, D1 of C 2,3,5, 7,12&24; every 12 cycles thereafter until EOT
    13. Part 2: At 12 months; Part 3: At 138 events
    14. D1 of every 3rd cycle (Cycles 3,6,9,12) until progressive disease (PD)
    1.Cuando se hayan incluido 50 sujetos y hayan sido tratados durante al menos 8 sem. o hayan suspendido el trat. del estudio.
    2-8.Parte2:a los 12meses;parte 3:cuando se hayan alcanzado 138acontecimientos.
    9.Parte2:a los 12meses;parte 3: cuando se hayan observado 205muertes.
    10.Cuando se produzca la progresión de la enfermedad y cada 6meses en sujetos con RC mantenida y respuesta completa estricta(RCe).
    11.Día(D)1 del ciclo(C)1,D2 C1,D1 de los ciclos 2,3,5,7,12,16y24;a partir de entonces,cada 12ciclos hasta el final del tratamiento(FDT).
    12.D1 C1,D2 C1,D1 de los ciclos 2,3,5,7,12y24;a partir de entonces,cada 12ciclos hasta el FDT.
    13.Parte2:a los 12meses;parte 3:cuando se hayan alcanzado 138acontecimientos.
    14.D1 de cada 3ciclos(ciclos3,6,9,12)hasta la progresión de la enfermedad(PE).
    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 No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker Analyses.
    Inmunogenicidad y análisis de biomarcadores.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Multicenter study
    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 EEA23
    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
    Belgium
    France
    Germany
    Greece
    Israel
    Russian Federation
    Spain
    Turkey
    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
    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 months2
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days22
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 44
    F.4.2.2In the whole clinical trial 386
    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)
    The sponsor will provide standard of care treatment.
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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