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    Summary
    EudraCT Number:2015-002993-19
    Sponsor's Protocol Code Number:54767414MMY3010
    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:2016-01-13
    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 number2015-002993-19
    A.3Full title of the trial
    An Open-Label Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent
    Protocolo de uso de tratamiento abierto para daratumumab en sujetos con mieloma múltiple que han recibido al menos 3 líneas de tratamiento previas (incluido un inhibidor del proteasoma y un fármaco inmunomodulador) o tienen resistencia doble a un inhibidor del proteasoma y un fármaco inmunomodulador
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early Access Treatment with Daratumumab for (Relapsed or Refractory) Multiple Myeloma
    Acceso al Tratamiento precoz con Daratumumab para (recidivante o resistente) Mieloma Múltiple
    A.4.1Sponsor's protocol code number54767414MMY3010
    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, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 7228100
    B.5.5Fax number+34 91 7228628
    B.5.6E-mailagonza45@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 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
    Multiple myeloma
    Múltiple mieloma
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Daratumumab
    Early access
    Multiple mieloma
    Daratumumab
    Acceso temprano
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 objective of this study is to provide early access to daratumumab treatment and collect additional
    safety data while the medication is not commercially available for subjects with multiple myeloma who
    have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an
    immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.
    El objetivo de este estudio es proporcionar acceso anticipado al tratamiento con daratumumab y recopilar datos de seguridad adicionales mientras el medicamento no esté comercializado para los pacientes con mieloma múltiple que han recibido al menos 3 líneas de tratamiento previas, incluido un inhibidor del proteasoma (IP) y un fármaco inmunomodulador (FIM), o que tienen resistencia doble, tanto a un inhibidor del IP como a un FIM.
    E.2.2Secondary objectives of the trial
    There is no hypothesis associated with this objective.
    No hay hipótesis asociada con este objetivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject must be at least 18 years of age
    - Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria:
    Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal
    to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months)
    OR
    Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (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
    - Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1,or 2
    - A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
    - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
    - Sujeto ? 18 años de edad
    -El sujeto debe tener documentado Mieloma Multiple y tener evidencia de progresión de la enfermedad al tratamiento anterior más reciente definido por los criterios internacionales IMWG
    Sujetos que hayan recibido al menos 3 líneas previas de tratamiento incluyendo un inhibidor del proteasoma (mayor o igual a 2 ciclos o 2 meses de tratamiento) y un agente inmunomudolador ( 2 ciclos o 2 meses de tratamiento) en cualquier orden durante el curso del tratamiento (excepto en sujetos que discontinuan cualquiera de los tratamientos debido a reacción alergica severa dentro de los dos primeros ciclos/meses) o sujetos cuya enfermedad es doble refractaria a un inhibidor del proteasoma (IP) y un agente inmunomodulador (IMiD). Para sujetos que hayan recibido más de un tipo de IP, su enfermedad debe ser refractaria al más reciente. Similarmente, para aquellos que hayan recibido más de un tipo de IMiD, su enfermedad debe ser refractaria al más reciente.
    - Sujetos con estado funcional (ECOG) 0, 1 ó 2.
    - Prueba de embarazo negativa en orina o suero en la visita de selección en mujer fértil.
    - Hombre sexualmente activo con una mujer en edad fértil y no vasectomizado deben acordar usar un método anticonceptivo de barrera durante el estudio, así como también todos los hombres no deben donar esperma durante el estudio y durante 6 meses después de recibir la última dosis del fármaco.
    E.4Principal exclusion criteria
    - Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
    - Subject receives any other anti-myeloma therapy while receiving daratumumab
    - Enrolled in another interventional clinical study with therapeutic intent
    - Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
    - Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
    - Prior exposure to any anti-CD38 monoclonal antibody
    - Haber estado incluido en otro studio de Daratumumbar o elegible para ser incluido en otro estudio clínico en marcha con Daratumumab.
    - Sujeto que reciba otra terapia anti mieloma mientras reciban daratumumab.
    - Incluido en otro estudio clínico intervencional con intención terapeutica.
    - Sujeto con conocimiento de Enfermedad obstructiva pulmonar crónica (EPOC) con un volumen espiratorio forzado en 1 segundo (FEV1) inferior al 50% del valor de lo normal
    - Sujeto con conocimiento de asma persistente moderada o grave en los últimos 2 años, o que actualmente ha no controlada el asma de cualquier clasificación
    - Exposición previa a cualquier anticuerpo monoclonal anti-CD38
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Italy
    Russian Federation
    Spain
    United Kingdom
    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
    Each country will be closed to enrollment when HA appr. has been received or the max. nr. of subjects have been enrolled.Enrolled subjects will be transitioned from study drug to commercial product once commercial product is available by doctor?s prescription or when daratumumab can be accessed from another source,and will be withdrawn from this study at that time.Study will be completed when the last study assessment for the last subject is complete.Further information within the study protocol
    La inclusión en cada país se cerrará cuando se reciba la aprobación de las autoridades o se haya incluido al número máximo de sujetos. Los sujetos pasarán del fármaco del estudio al producto comercial cuando éste se encuentre disponible con receta o cuando se pueda acceder a él por otra vía, y serán retirados de este estudio en ese momento. El estudio se considerará finalizado con la última evaluación del estudio del último sujeto participante en el mismo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 1060
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 940
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 2000
    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)
    Enrolled subjects will be transitioned from study drug to commercial product once commercial product is available (or when daratumumab can be accessed from another source)
    Los pacientes incluidos pasarán del fármaco del estudio a producto comercial una vez el producto comercial esté disponible (o cuando se pueda acceder a daratumumab por otra vía)
    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 Decision2016-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-02
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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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