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    Summary
    EudraCT Number:2013-005525-23
    Sponsor's Protocol Code Number:54767414MMY3003
    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:2014-04-01
    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 number2013-005525-23
    A.3Full title of the trial
    Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
    Ensayo fase 3 para comparar Daratumumab, Lenalidomida y dexametasona (DRd) frente a Lenalidomida y dexametasona (Rd) 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 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
    Ensayo para comparar Daratumumab, Lenalidomida y dexametasona frente a Lenalidomida y dexametasona en sujetos con mieloma múltiple.
    A.4.1Sponsor's protocol code number54767414MMY3003
    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 number91 722 81 00
    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 16.1
    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 compare the efficacy of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free
    survival (PFS) in subjects with relapsed or refractory multiple myeloma.
    El objetivo principal es comparar la eficacia del daratumumab combinado con lenalidomida y dexametasona (DRd) con la de lenalidomida y dexametasona (Rd) en la supervivencia sin progresión (SSP) en sujetos con mieloma múltiple en recaída o refractario.
    E.2.2Secondary objectives of the trial
    The major secondary objectives are as follows:
    - To compare the 2 treatment groups with respect to time to disease progression (TTP), overall response rate (ORR), and overall survival (OS).
    - To compare the 2 treatment groups with respect to the proportion of subjects with a response of very good partial response (VGPR) or better.
    - To compare the 2 treatment groups with respect to duration of and time to response.
    - To compare the 2 treatment groups with respect to time to subsequent antimyeloma treatment.
    - To assess the safety and tolerability of daratumumab when administered in combination with Rd.
    Los objetivos secundarios fundamentales son:
    -Comparar los dos grupos de tratamiento respecto al tiempo hasta la progresión de la enfermedad (TP), la tasa de respuesta global (TRG) y la supervivencia global (SG).
    -Comparar los dos grupos de tratamiento respecto a la proporción de sujetos con una respuesta parcial muy buena (RPMB) o mejor.
    -Comparar en los dos grupos de tratamiento la duración y el tiempo hasta la respuesta.
    -Comparar en los dos grupos de tratamiento el tiempo hasta el tratamiento posterior del mieloma.
    -Valorar la seguridad y la tolerabilidad del daratumumab cuando se administra combinado con Rd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    - Must have documented multiple myeloma and measurable disease
    - Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
    - Must have documented evidence of progressive disease as defined
    by the International Myeloma Working Group criteria on or after their last regimen
    - Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
    Criterios de inclusion:
    -Tener documentado mieloma múltiple comprobado y enfermedad mensurable.
    -Haber recibido al menos una línea previa de tratamiento para el mieloma múltiple y haber conseguido una respuesta (RP o mejor) al menos a un régimen previo.
    -Tener pruebas documentadas de progresión de la enfermedad , definida por los criterios del IMWG, en o después del último régimen.
    -Tener una puntuación del estado funcional del ECOG de 0, 1 ó 2
    E.4Principal exclusion criteria
    Exclusion Criteria:
    - Has received any of the following therapies: daratumumab or other anti-CD38 therapies
    - Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
    - Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
    - Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
    - History of malignancy (other than multiple myeloma) within 3 years before the date of randomization
    Criterios de exclusion:
    -Haber recibido previamente cualquiera de estas terapias: daratumumab u otros tratamientos anti-CD38.
    -Haber recibido tratamiento contra el mieloma en las dos semanas o cinco semividas del tratamiento
    - La enfermedad del sujeto muestra signos de resistencia o intolerancia a la lenalidomida o si previamente se ha tratado con un régimen que contenía lenalidomida, se le excluirá si Lo interrumpió por cualquier acontecimiento adverso relacionado con el tratamiento previo con lenalidomida.
    -Haber recibido alotransplante de celulas madre en las 12 semanas previas a la fecha de la aleatorización, o ha recibido previamente un alotrasplante de células madre (con independencia del momento) o que tengan previsto someterse a un trasplante de células madre antes de la progresión de la enfermedad.
    -Antecedentes de neoplasia maligna (distinta del mieloma múltiple) en los tres años previos a la fecha de aleatorización
    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
    Up to approximately 12 months (anticipated) after the last participant
    is randomized
    Hasta aproximadamente 12 meses (previsto) despues de que el ultimo paciente sea randomizado.
    E.5.2Secondary end point(s)
    1. Time to disease progression (PD)
    2. Overall response rate
    3. Number of participants who acheive very good partial response (VGPR) or better
    4. Time to complete response (CR) or partial response (PR)
    5. Overall survival
    6. Duration of response
    1.Tiempo hasta progresion de la enfermedad
    2. Tasa de respuesta global.
    3. Sujetos con una respuesta parcial muy buena (RPMB) o mejor.
    4. Respuesta completa (RC) o respuesta parcial (RP).
    5. Supervivencia global
    6. Duración de la respuesta.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - for Secondary outcome 1 - 4 = Up to approximately 12 months (anticipated) after the last participant is randomized

    - for Secondary outcome 5 = Up to approximately 5 years (anticipated) after the last participant is randomized

    - - for Secondary outcome 6 = Up to approximately 12 months (anticipated) after the last participant is randomized
    -Para objetivos secundarios 1-4: hasta aproximadamente 12 meses (previsto) después de que el último paciente sea randomizado.
    -Para objetivo secundario 5: Hasta aproximadamente 12 meses (previsto) después de que el ultimo paciente sea randomizado
    -Para objetivo secundario 6: Hasta aproximadamente 12 meses (previsto) después de que el ultimo paciente sea randomizado.
    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 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 No
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Canada
    France
    Greece
    Netherlands
    Sweden
    Australia
    Germany
    Korea, Republic of
    Spain
    Israel
    Poland
    Russian Federation
    Taiwan
    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 study end is defined as when 334 deaths have occurred."
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 242
    F.4.2.2In the whole clinical trial 500
    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)
    refer to protocol
    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 Decision2014-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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