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    Summary
    EudraCT Number:2019-001413-16
    Sponsor's Protocol Code Number:68284528MMY3002
    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:2019-12-20
    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 number2019-001413-16
    A.3Full title of the trial
    A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
    Estudio aleatorizado en fase III que compara JNJ-68284528, una terapia de linfocitos T con receptor quimérico para el antígeno (T-CAR) dirigida contra el antígeno de maduración de los linfocitos B (BCMA), frente a pomalidomida, bortezomib y dexametasona (PVd) o daratumumab, pomalidomida y dexametasona (DPd) en sujetos con mieloma múltiple en recidiva y refractario a lenalidomida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
    Estudio aleatorizado en fase III que compara JNJ-68284528 frente a pomalidomida, bortezomib y dexametasona (PVd) o daratumumab, pomalidomida y dexametasona (DPd) en sujetos con mieloma múltiple en recidiva y refractario a lenalidomida.
    A.3.2Name or abbreviated title of the trial where available
    CARTITUDE-4
    A.4.1Sponsor's protocol code number68284528MMY3002
    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 NV
    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 NV
    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 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 524 21 66
    B.5.5Fax number+31 71 524 21 10
    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-68284528
    D.3.2Product code JNJ-68284528
    D.3.4Pharmaceutical form Dispersion 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeJNJ-68284528
    D.3.9.3Other descriptive nameJNJ-68284528
    D.3.9.4EV Substance CodeSUB197280
    D.3.10 Strength
    D.3.10.1Concentration unit kg kilogram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.0
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberThe EMA/CAT considers that product JNJ-68284528, falls within the definition of gene therapy medicinal product. Product ref.: H0005095
    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 Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 RoleComparator
    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 JNJ-54767414
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    D.3.9.3Other descriptive nameHuMax-CD38, 3003-005
    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 number120
    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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebortezomib
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 RoleComparator
    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 nameIMNOVID
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel Munchener Str. 15
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.4Pharmaceutical form Tablet
    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 INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDexamethson
    D.3.9.4EV Substance CodeSUB07017MIG
    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.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 and lenalidomide-refractory multiple myeloma (MM)
    Mieloma múltiple en recidiva y refractario a lenalidomida
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of JNJ 68284528 with standard therapy, either PVd or DPd
    Comparar la eficacia de JNJ‑68284528 con el tratamiento de referencia, ya sea PVd o DPd
    E.2.2Secondary objectives of the trial
    1.To further compare the efficacy of JNJ 68284528 with standard therapy, either PVd or DPd
    2. To assess the safety profile of JNJ 68284528
    3. To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528
    4. To assess the immunogenicity of JNJ 68284528
    5. To evaluate the impact of JNJ-68284528 treatment on the health-related quality of life of subjects compared with standard therapy, either PVd or DPd
    1.Comparar la eficacia de JNJ 68284528 con el tratamiento de referencia, PVd o DPd
    2.Evaluar el perfil de seguridad de JNJ 68284528
    3.Caracterizar la farmacocinética y la farmacodinamia de JNJ-68284528
    4.Evaluar la inmunogenicidad de JNJ-68284528
    5.Evaluar la repercusión del tratamiento con JNJ-68284528 en la calidad de vida relacionada con la salud de los sujetos en comparación con el tratamiento de referencia, PVd o DPd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be at least 18 years of age.
    2. Have documented diagnosis of MM as defined by the criteria below:
    -Multiple myeloma diagnosis according to the IMWG diagnostic criteria
    -Measurable disease at screening as defined by any of the following:
    -Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -Light chain MM without measurable M-protein in the serum or the urine: Serum free light chain ≥10 mg/dL and abnormal serum free light chain ratio.
    3. Have received 1 to 3 prior lines of therapy including a PI and IMiD. Subject must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy
    4. Have documented evidence of PD by IMWG criteria based on investigator’s determination on or within 6 months of their last regimen.
    5. Subjects with only 1 prior line of therapy must have progressed within 36 months of a stem cell transplant or if not transplanted, then within 42 months of starting initial therapy.
    6. Be refractory to lenalidomide per IMWG consensus guidelines (progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For subjects with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy.
    7. Have an ECOG Performance Status score of 0 or 1
    8. Have clinical laboratory values as specified in the protocol.

    For additional information see section 5.1 of the protocol
    1. Tener al menos 18 años.
    2. Tener un diagnóstico confirmado de MM según criterios:
    · Diagnóstico de MM según los criterios de diagnóstico del IMWG.  
    · Una enfermedad medible en la selección definida por:
    · Concentración de la proteína M ≥1,0 g/dl o concentración de proteína M en orina ≥200 mg/24 horas, o
    · MM de cadenas ligeras sin proteína M medible en suero u orina: Cadena ligera libre en suero ≥10 mg/dl y proporción anormal de cadenas ligeras libres en suero.
    3.Haber recibido de 1 a 3 líneas de tratamiento, incluyendo un IP y un IMiD. El sujeto debe haber recibido al menos 1 ciclo de tratamiento completo por cada línea de tratamiento, salvo que la EP fuera la mejor respuesta a la línea de tratamiento.
    4.Tener evidencia de EP según criterios del IMWG o en un plazo de 6 meses desde su últim tratamiento. 
    5.Los sujetos con solo 1 línea de tratamiento previa deben haber progresado en los 3 años posteriores al TACM o, si no se han sometido a un trasplante, en los 3 años posteriores al inicio del tratamiento. 
    6.Ser refractario a la lenalidomida conforme a IMWG (progresión a los 60 días o antes de que transcurran 60 días desde la finalización del tratamiento). La progresión en el mantenimiento de lenalidomida cumplirá este criterio. Para los sujetos con más de 1 línea de tratamiento previa, no es necesario ser refractario a la lenalidomida en la línea de tratamiento anterior más reciente.
    7.  ECOG de 0 o 1.
    8.Tener valores clínicos de laboratorio que cumplan los siguientes criterios durante la fase de selección (de acuerdo con protocolo).

    Para más información consultar sección 5.1 del protocolo.
    E.4Principal exclusion criteria
    1.Prior treatment with CAR-T therapy directed at any target.
    2. Any previous therapy that is targeted to BCMA.
    3. Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia.
    4. Subjects with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive PVd as standard therapy or bridging therapy; however, subject may receive DPd as standard therapy or bridging therapy.
    5. Was vaccinated with live attenuated vaccines within 4 weeks prior to randomization
    6. Subject received any antitumor therapy as specified in the protocol, prior to randomization
    7. Active malignancies (ie, progressing or requiring treatment change in the last
    24 months) other than the disease being treated under study. Refer to the protocol for allowed exceptions.
    8. Plasma cell leukemia at the time of screening, Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
    9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to JNJ 68284528 or its excipients, including dimethylsulfoxide, or to fludarabine, cyclophosphamide, tocilizumab, pomalidomide, dexamethasone.
    10. Stroke or seizure within 6 months of signing ICF.
    11. Received either of the following:
    -An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Subjects with active graft-versus-host disease are excluded.
    -An autologous stem cell transplantation ≤ 12 weeks before apheresis.
    12. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.
    For additional information, see section 5.2 of the protocol
    1. Tratamiento anterior con cualquier terapia dirigida de linfocitos T-CAR.
    2. Cualquier terapia previa dirigida a los antígenos de maduración de células B (BCMA).
    3. Toxicidad continua de un tratamiento previo contra el cáncer que no se ha resuelto volviendo a los niveles iniciales o hasta un grado 1 o inferior, salvo en caso de alopecia.
    4. Los sujetos con neuropatía periférica de grado 1 con dolor o neuropatía periférica de grado 2 o superior no podrán recibir PVd como tratamiento de referencia o terapia puente; sin embargo, el sujeto puede recibir DPd como tratamiento de referencia o terapia puente.
    5. Haber sido vacunado en las 4 semanas anteriores a la aleatorización.
    6. El sujeto recibió cualquier terapia antitumoral (ver protocolo), antes de la aleatorización.
    7. Presencia de enfermedades malignas (que hayan requerido tratamiento en los últimos 24 meses). Consultar protocolo para ver excepciones.
    8. Leucemia de células plasmáticas en la selección, macroglobulinemia de Waldenström, síndrome POEMS (polineuropatía, organomegalia, endocrinopatía, proteína monoclonal y alteraciones cutáneas) o amiloidosis AL primaria.
    9. Contraindicaciones o alergias potencialmente mortales, hipersensibilidad o intolerancia a JNJ 68284528 o sus excipientes, incluido dimetilsulfóxido o fludarabina, ciclofosfamida, tocilizumab, pomalidomida, dexametasona.
    10. Accidente cerebrovascular o convulsiones en los 6 meses previos a la firma del consentimiento.
    11. Haber recibido cualquiera de los siguientes:
    • Un alotrasplante de células madre en los 6 meses anteriores a la aféresis. Durante 6 semanas se deben haber suspendido los medicamentos inmunodepresores a los sujetos que hayan recibido un alotrasplante sin indicios de enfermedad de injerto contra huésped. Se excluyen los sujetos con enfermedad de injerto contra huésped.
    • Un alotrasplante de células madre ≥12 semanas antes de la aféresis.
    12. Antecedentes o afectación activa conocida del sistema nervioso central (SNC) o signos clínicos de afectación meníngea del MM.

    Para más información consultar sección 5.2 del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 6 years)
    Evaluación mensual desde la aleatorización hasta la enfermedad progresiva (EP) o muerte, lo que ocurra antes (aprox. 6 años)
    E.5.2Secondary end point(s)
    1. Rate of CR/sCR
    2. Overall MRD negative rate
    3. Rate of MRD negativity in subjects with CR/sCR at
    12 months ±3 months
    4. Rate of sustained MRD negative status
    5. OS
    6. ORR
    7. PFS on next line of therapy (PFS2)
    8. Incidence and severity of adverse events
    9. Pharmacokinetic and pharmacodynamic markers
    including but not limited, to systemic cytokine
    concentrations, and markers of CAR-T cells, T cell
    expansion (proliferation), and persistence via
    monitoring CAR-T positive cell counts and CAR
    transgene level.
    10. Presence of anti-JNJ-68284528 antibodies
    11. Change from baseline in health-related quality of life
    (HRQoL) subscale scores from the European
    Organization for Research and Treatment of Cancer
    (EORTC) QLQ-C30, Multiple Myeloma Symptom and
    Impact Questionnaire (MySIm-Q), EuroQol Five
    Dimension Questionnaire (EQ-5D-5L), Patient Global
    Impression of Severity (PGIS), and the Patient Reported Outcomes version of the Common
    Terminology Criteria for Adverse Events (PRO-CTCAE)
    items.
    1. Tasa de RC/RCe
    2. Tasa global de la EMR negativa.
    3. Tasa de EMR negativa en sujetos con RC/RCe a los 12 meses ±3 meses.
    4. Tasa de la EMR negativa mantenida.
    5. SG
    6. TRG
    7. SLP en la siguiente línea de terapia (SLP2)
    8. Incidencia y gravedad de los eventos adversos.
    9. Marcadores farmacodinámicos y farmacocinéticos, entre los que se incluyen concentraciones generales de citocinas y marcadores de linfocitos T-CAR, expansión de linfocitos T (proliferación) y supervivencia mediante la supervisión del recuento de linfocitos T-CAR positivos y el nivel del transgén CAR.
    10. Presencia de anti cuerpos anti-JNJ-68284528.
    11. Cambio respecto al momento de referencia en las puntuaciones de la subescala de la calidad de vida relacionada con la salud (CdVRS) mediante el cuestionario QLQ-C30 de la Organización Europea para la Investigación y Tratamiento del Cáncer (EORTC), el cuestionario Síntomas e impacto del mieloma múltiple (MySIm-Q), el cuestionario EuroQol de cinco dimensiones (EQ-5D-5L), la impresión global de la gravedad del paciente (PGIS) y la versión de los resultados comunicados por el paciente (PRO) de los Criterios de terminología común para acontecimientos adversos (PRO-CTCAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Followed until the end of the study (approximately up to 6 years)
    Seguimiento hasta fin de estudio (aprox. hasta 6 años)
    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 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Australia
    Belgium
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    Spain
    Sweden
    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 end of study is when approximately 250 deaths have occurred in the study.
    se considerará fin de estudio cuando hayan ocurrido 250 muertes
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 400
    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)
    After the end of the study, the sponsor will continue to monitor subjects treated with JNJ-68284528 for up to 15 years after administration of JNJ-68284528 on a separate long-term follow-up study for complications of lentiviral integration, potential delayed adverse events, including SPMs.
    Después de completar este estudio, el promotor hará un seguimiento de los sujetos que hayan sido tratados con JNJ-68284528 hasta 15 años después de la última dosis con JNJ-68284528 en un estudio de seguimiento para evaluar posibles complicaciones de integración de lentivirus, y potenciales acontecimientos adversos incluyendo nuevas enfermedades malignas.
    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 Decision2020-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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