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    Summary
    EudraCT Number:2014-002272-88
    Sponsor's Protocol Code Number:54767414MMY3007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 number2014-002272-88
    A.3Full title of the trial
    A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib)
    Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination with VMP
    (D-VMP), in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for
    High-dose Therapy
    Estudio de Fase 3, aleatorizado, controlado y abierto, de VELCADE (bortezomib)-melfalán-prednisona (VMP) frente a daratumumab en combinación con VMP (D VMP) en sujetos con mieloma múltiple no tratado previamente que no son elegibles para quimioterapia a dosis altas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Combination of Daratumumanb and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants with Previously Untreated Multiple Myeloma
    Estudio de comparación de Daratumumab y Velcade (bortezomib) Melfalán-Prednisona (VMP) comparado con Velcade Melfalán-Prednisona (VMP) en participantes con mieloma múltiple no tratado previamente
    A.4.1Sponsor's protocol code number54767414MMY3007
    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+34913913443
    B.5.5Fax number+31 715242110
    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 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 CodeSUB29447
    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
    Multiple myeloma
    Mieloma múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Mieloma múltiple
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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
    The primary objective is to determine if the addition of daratumumab to VMP will prolong PFS compared with VMP.
    El objetivo principal es determinar si la adición de daratumumab a VMP prolonga la supervivencia sin progresión (SSP) en comparación con VMP.
    E.2.2Secondary objectives of the trial
    - To determine if the addition of daratumumab to VMP will improve clinical outcome as measured by:
    Time to disease progression (TTP)
    Stringent CR (sCR) rate
    CR rate
    PFS2 (defined as time from randomization to progression on the next line of therapy or death, whichever comes first)
    Time to next treatment
    Overall response rate (CR + partial response [PR] rate)
    Proportion of subjects who achieve very good partial response (VGPR) or better
    Duration of response
    Overall survival
    - To determine the ability of daratumumab to reduce minimal residual disease (MRD)
    - To assess patient reported outcomes and heath economic/resource utilization
    - To determine the pharmacokinetics and immunogenicity of daratumumab
    - To assess the safety and tolerability of daratumumab when administered in combination with VMP
    - To evaluate clinical efficacy of daratumumab when added to VMP in high risk molecular subgroups.
    -Determinar si la adición de daratumumab a VMP mejora el desenlace clínico en su valoración mediante:
    Tiempo hasta la progresión de la enfermedad
    Tasa de respuesta completa estricta
    Tasa de respuesta completa
    SSP2
    Tiempo hasta el siguiente tratamiento
    Tasa de respuesta global (tasa de RC+respuesta parcial)
    % de sujetos que alcancen una respuesta parcial muy buena o mejor
    Duración de la respuesta
    Supervivencia global
    -Determinar la capacidad del daratumumab para reducir la enfermedad residual mínima
    -Evaluar los resultados comunicados por el paciente y la economía sanitaria/utilización de recursos
    -Determinar la farmacocinética y la inmunogenia del daratumumab
    -Evaluar la seguridad y la tolerabilidad del daratumumab administrado en combinación con VMP
    -Evaluar la eficacia clínica del daratumumab añadido a VMP en subgrupos moleculares de alto riesgo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant with documented multiple myeloma satisfying the CRAB criteria and measurable disease
    - Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in participants <65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with
    stem cell transplantation
    - Participant must have an Eastern Cooperative Oncology Group (ECOG)
    performance status score of 0, 1, or 2
    - Meet the clinical laboratory criteria as specified in the protocol
    - A woman of childbearing potential must have a negative serum pregnancy test at screening within 7 days prior to randomization
    - Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner´s vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to
    hysterectomy or bilateral oophorectomy
    -Con mieloma múltiple documentado que cumpla los criterios CRAB y enfermedad medible ?
    -Sujeto con diagnóstico reciente y considerado inadecuado para quimioterapia en dosis altas con trasplante de células madre por: Edad >/= 65 años, o en sujetos <65 años: una o varias enfermedades concomitantes importantes que probablemente influyan negativamente en la tolerabilidad de la quimioterapia en dosis altas con trasplante de células madre.
    -Puntuación del estado funcional del ECOG de 0, 1 o 2
    -Resultados de los análisis clínicos antes del tratamiento que cumplan los criterios especificados en el protocolo
    -Las mujeres potencialmente fértiles deben presentar un resultado negativo en una prueba de embarazo en suero u orina en la selección, en el plazo de los 7 días anteriores la aleatorización.
    -Las mujeres potencialmente fértiles deben comprometerse a abstenerse en todo momento de mantener relaciones heterosexuales o a utilizar dos métodos anticonceptivos fiables simultáneamente, lo que comprende un anticonceptivo de alta eficacia (ligadura de trompas, dispositivo intrauterino, anticonceptivo hormonal [oral, inyectable, en parches, en anillos vaginales o en implantes] o vasectomía de la pareja) y otro método anticonceptivo eficaz (preservativo masculino de látex o sintético, diafragma o capuchón cervical). La anticoncepción debe comenzar antes del tratamiento. La anticoncepción fiable está indicada incluso con antecedentes de infertilidad, excepto que se deba a histerectomía u ovariectomía bilateral
    E.4Principal exclusion criteria
    - Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
    - Participant has a diagnosis of Waldenstrom´s disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
    - Participant has prior or current systemic therapy or stem cell transplantation (SCT) for multiple myeloma, with the exception of an emergency use of a short course of corticosteroids before treatment
    - Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher,
    as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 4
    - Participant has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical
    monitor, is considered cured with minimal risk of recurrence within 3 years)
    - Participant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
    -Sujeto con diagnóstico de amiloidosis primaria, gammapatía monoclonal de significación indeterminada o mieloma múltiple quiescente.
    -Sujeto con diagnóstico de enfermedad de Waldenström u otros procesos con proteína M de tipo IgM en ausencia de una infiltración de plasmocitos clonales con lesiones óseas líticas.
    -Sujeto con tratamiento sistémico anterior o actual o trasplante de células madre por mieloma múltiple, excepto la administración de urgencia de un ciclo corto de corticosteroides antes del tratamiento.
    -Sujeto con neuropatía periférica o dolor neuropático de grado 2 o superior, según la definición de los NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), versión 4.
    -Sujeto con antecedentes de neoplasia maligna (distinta del mieloma múltiple) en el plazo de los 3 años anteriores a la fecha de la aleatorización (son excepciones el carcinoma cutáneo espinocelular o basocelular y el carcinoma in situ de cuello uterino, así como toda neoplasia maligna que, en opinión del investigador y de acuerdo con el monitor médico del promotor, se considere curada y con un riesgo mínimo de recidiva en un plazo de 3 años).
    -Sujeto con enfermedad o proceso médico o psiquiátrico concomitante (por ejemplo, infección sistémica activa, diabetes no controlada, neumopatía infiltrativa difusa aguda) que probablemente vaya interferir en los procedimientos o resultados del estudio, o que, en opinión del investigador, suponga un riesgo para la participación en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free Survival (PFS)
    supervivencia sin progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assess at approximately 41 months from randomization
    Valoración aproximadamente 41 meses desde la aleatorización
    E.5.2Secondary end point(s)
    1. Time to DiseaseProgression (TTP)
    2. Percentage of Participants Achieving Stringent Complete Response (sCR)
    3. Percentage of Participants Achieving Complete Response (CR)
    4. Progression-free Survival on Next Line of Therapy (PFS2)
    5. Percentage of Participants With Minimal Residual Disease (MRD)
    6. Time to Next Treatment
    7. Overall Response Rate (ORR)
    8. Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better
    9. Duration of Response
    10. Overall Survival (OS)
    1.Tiempo hasta la progresión de la enfermedad (THP)
    2.Porcentaje de sujetos que alcancen una Respuesta completa estricta (RCe)
    3.Porcentaje de sujetos que alcancen una Respuesta completa (RC)
    4.Supervivencia sin progresión con la siguiente línea de tratamiento (SSP2)
    5.Porcentaje de sujetos con la enfermedad residual mínima (ERM)
    6.Tiempo hasta el siguiente tratamiento
    7.Tasa de respuesta global (TRG)
    8.Porcentaje de sujetos que alcancen una RPMB o mejor
    9.Duración de la respuesta
    10.Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For secondary end points 1-4, 6-9 = Assess at approximately 41 months
    from randomization
    - For secondary end points 5 = Week 58, 84, and 110
    - For secondary end points 10 = Assess at approximately 41 months after first patient randomized up to a maximum of 5 years after last participant is dosed
    - Para los criterios de valoración secundarios 1-4, 6-9 = Valoración aproximadamente en 41 meses desde la aleatorización
    - Para el critero secundario de valoración 5 = Semana 58, 84 y 110
    - Para el criterio de valoración 10 = Valoración aproximadamente 41 meses desde la aleatorización del primer paciente hasta un máximo de 5 años después de la finalización del último paciente.
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Georgia
    Germany
    Greece
    Hungary
    Italy
    Japan
    Macedonia, the former Yugoslav Republic of
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Spain
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the following is included in the protocol : The end of the study will occur when 330 subjects have died, or 5 years after the last subject is randomized, whichever comes first.
    Lo siguiente está incluido en el protocolo: El fin del estudio tendrá lugar cuando hayan fallecido 330 sujetos, o 5 años después de la aleatorización del último sujeto, lo que suceda antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years7
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 665
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 503
    F.4.2.2In the whole clinical trial 700
    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)
    If you are benefiting from study treatment when the study is over, the option to continue study medication treatment will be made available to you; your study doctor will explain the requirements for continued use of study medication.
    Si se está beneficiando del tratamiento del estudio cuando el estudio termine, tendrá la opción de continuar con la medicación del estudio; el médico del estudio explicará los requerimeintos para continuar usando la medicación del estudio.
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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