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    Summary
    EudraCT Number:2013-000506-37
    Sponsor's Protocol Code Number:ECWM-1
    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:2015-06-10
    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 number2013-000506-37
    A.3Full title of the trial
    Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström's Macroglobulinemia
    Eficacia del esquema Dexametasona, Rituximab y Ciclofosfamida (DRC) con o sin Bortezomib como tratamiento de 1ª línea para pacientes con Macroglobulinemia de Waldenström
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström's Macroglobulinemia
    Eficacia de DRC con o sin Borteomib como primer tratamiento en pacientes con Macroglobulinemia de Waldenström
    A.3.2Name or abbreviated title of the trial where available
    DRC +/- bortezomib for Waldenström's Macroglobulinemia
    DRC +/- bortezomib para la Macroglobulinemia de Waldenström
    A.4.1Sponsor's protocol code numberECWM-1
    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 SponsorUniversity Hospital Ulm
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJohnson & Johnson
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportRoche Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinAssess GmbH
    B.5.2Functional name of contact pointDr. Burkhard Deuß
    B.5.3 Address:
    B.5.3.1Street AddressBirkenbergstr. 82
    B.5.3.2Town/ cityLeverkusen
    B.5.3.3Post code51379
    B.5.3.4CountryGermany
    B.5.4Telephone number00492171363360
    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 Yes
    D.2.1.1.1Trade name Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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: 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 MabThera 500 mg in 50 ml
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRituximab
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 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 MabThera 1400mg in 11.7mL
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRituximab
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1400
    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.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
    Waldenström's Macroglobulinemia
    Macroglobulinemia de Waldenström
    E.1.1.1Medical condition in easily understood language
    Waldenström's Macroglobulinemia
    Macroglobulinemia de Waldenström
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10047801
    E.1.2Term Waldenstrom's macroglobulinaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 of the trial is to evaluate whether the addition of Bortezomib to the combination regimen Dexamethasone/Rituximab/Cyclophosphamide (B-DRC) improves PFS compared to DRC alone.
    El objetivo (aim) principal del ensayo es evaluar si la adición de bortezomib a la combinación dexametasona / rituximab / ciclofosfamida (B-DRC) mejora la SLP en comparación con solo DRC.
    E.2.2Secondary objectives of the trial
    To compare the efficacy and safety of bortezomib in combination with DRC using other parameters of efficacy:
    - Response rates (CR, VGPR, PR, MR) and overall response (ORR) four weeks after the end of induction therapy
    - Best response
    - Time to best response
    - Time to first response
    - Time to treatment failure
    - Remission Duration
    - Cause specific survival
    - Overall survival
    También se comparará la eficacia y seguridad de bortezomib más DRC con otros parámetros:
    - Tasa de respuesta (RC, RPMB, RP, RM) y de respuesta global (RG) a las cuatro semanas del final de la terapia de inducción
    - Mejor respuesta
    - Tiempo hasta la mejor respuesta
    - Tiempo hasta la primera respuesta
    - Tiempo hasta el fracaso terapéutico
    - Duración de la remisión
    - Supervivencia hasta la muerte por causa de la MW (Cause specific survival)
    - Supervivencia Global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A) Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study inclusion and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study inclusion and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will include at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low-grade B-cell malignancies.

    B) Patients must have at least one of the following critera to initiate treatment as defined by "Consensus Panel Two" recommendations from the Second International Workshop on Waldenström Macroglobulinemia.
    a) Recurrent fever, night sweats, weight loss, fatigue
    b) Hyperviscosity
    c) Lympadenopathy which is either symptomatic or bulky (>5cm in maximum diameter)
    d) Symptomatic hepatomegaly and/or splenomegaly
    e) Symptomatic organomegaly and/or organ or tissue infiltration
    f) Peripheral neuropathy due to WM
    g) Symptomatic cryoglobulinemia
    h) Cold agglutinin anemia
    i) IgM related immune hemolytic anemia and/or thrombocytopenia
    j) Nephropathy related to WM
    k) Amyloidosis related to WM
    l) Hemoglobin ?10g/dL
    m) Platelet count <100x10e9/L
    n) Serum monoclonal protein >5g/dL, even with no overt clinical symptoms

    C) Cumulative illness rating scale (CIRS) score less than 6 (see annex).

    D) World Health Organization (WHO)/ECOG performance status 0 to 2.

    E) Other criteria
    a) Age ? 18 years
    b) Life expectancy >3 months.
    c) Baseline platelet count ?50x109/L (if not due to BM infiltration by the lymphoma), absolute neutrophil count ?0.75x109/L.
    d) Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
    - ASAT (SGOT): ?3 times the upper limit of institutional laboratory normal value
    - ALAT (SGPT): ?3 times the upper limit of institutional laboratory normal value
    - Total Bilirubin: ?20 mg/L or 2 times the upper limit of institutional laboratory normal value, unless clearly related to the disease (except if due to Gilbert?s syndrome)
    - Serum creatinine ? 2mg/dl
    F) Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
    G) Men must agree not to father a child for the duration of therapy and 6 months after and must agree to advice a female partner to use a highly effective method of birth control.
    H) Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
    A. DIAGNÓSTICO CLÍNICO PATOLÓGICO DE MW
    Tal y como se define por el panel de consenso de uno de el Segundo Taller Internacional sobre MW. El diagnóstico histopatológico debe tenerse ocurrir antes de la inclusión y aleatorización en el estudio. Además, se enviarán muestras al centro anatomopatológico de referencia nacional en el momento de la inclusión y randomización. Se admite que un caso es CD20 positivo si se cuenta con tal dato desde cualquier estudio inmunohistoquímico o de citometría de flujo de médula ósea previo con un límite de hasta 6 meses antes de la inclusión en el protocolo. Dicha inclusión se basará en criterios morfológicos e inmunológicos. El inmunofenotipo se realizará en cada centro y los datos se guardarán de forma local. Se hará un estudio de citometría de flujo de médula ósea y células de la sangre periférica exigiéndose al menos una doble tinción para evaluar la expresión de los siguientes antígenos: inmunoglobulina de superficie, CD19, CD20, CD5, CD10 y CD23. Los pacientes son elegibles si las células tumorales expresan los antígenos CD19 y CD20 y son negativos para CD5, CD10 y CD23. Los pacientes con células tumorales positivas para CD5 y/o CD23 con características morfológicas similares a las células de MW se pueden incluir tras descartar otras neoplasias de células B.

    B. CRITERIOS DE TRATAMIENTO
    Los pacientes deben tener al menos una de las siguientes criterios para iniciar el tratamiento tal como se define por el "Segundo Consenso de Panel " recomendaciones del Segundo Taller Internacional sobre Waldenström Macroglobulinemia.
    - Fiebre recurrente, sudores nocturnos, pérdida de peso, fatiga.
    - Hiperviscosidad.
    - Linfadenopatía que es o bien sintomática o bien voluminosa (?5 cm de diámetro máximo).
    - Hepatomegalia y/o esplenomegalia sintomática.
    - Organomegalia sintomática y/o infiltración de tejidos y órganos
    - Neuropatía periférica debida a MW.
    - Crioglobulinemia sintomática.
    - Anemia por crioaglutinina.
    - Trombocitopenia y/o anemia hemolítica inmunitaria.
    - Nefropatía relacionada con MW.
    - Amiloidosis relacionada con MW.
    - Hemoglobina ?10 g/dL.
    - Recuento de plaquetas <100 · 109/L.
    - Proteína monoclonal sérica >5 g/dL incluso sin síntomas manifiestos.

    C. BUEN ESTADO FUNCIONAL
    Se requiere una puntuación inferior a 6 en la escala de calificación enfermedad Acumulada (CIRS) (véase el anexo).
    También se requiere un estado funcional de la OMS o ECOG 0-2 .

    D. OTROS CRITERIOS
    - Edad ? 18 años
    - Esperanza de vida superior a 3 meses .
    - Recuento de plaquetas basal ?50·10e9/L(si no se debe a BM infiltración por el linfoma).
    - Recuento absoluto de neutrófilos >0,75·10e9/L.
    - Cumplir con los siguientes criterios de laboratorio pre tratamiento en la visita de selección llevado a cabo dentro de los 28 días de inscripción en el estudio :
    - ASAT (SGOT): <3 veces el límite máximo de laboratorio institucional
    - ALAT (SGPT): <3 veces el límite máximo de laboratorio institucional
    - Bilirrubina Total: <2 mg/dL ó 2 veces el límite máximo del laboratorio institucional, a menos que sea claramente relacionado con la enfermedad o sea debido a un síndrome de Gilbert.
    - Creatinina sérica <2 mg/dL

    D. RIESGOS DE EMBARAZO
    Las mujeres premenopáusicas fértiles aceptarán utilizar un método control de la natalidad de alta eficacia durante la duración de la terapia y hasta 6 meses después de finalizar el tratamiento . Un método muy eficaz de control de la natalidad se define como las que resultan en una baja tasa de fallos (es decir, menos del 1% por año) cuando se usa de forma consistente y correctamente. Se aceptan como tales los implantes, inyectables, anticonceptivos orales combinados, algunos DIU, la abstinencia sexual complete y la pareja vasectomizada.
    Los hombres deben comprometerse a no engendrar un hijo durante el tratamiento y hasta 6 meses después de haberlo acabado, por lo que deberán ponerse de acuerdo con su pareja femenina a fin de utilizar un método muy eficaz de control de la natalidad .

    E. CONSENTIMIENTO INFORMADO
    Será necesaria la firma voluntaria del consentimiento informado por escrito antes de realizar cualquier procedimiento relacionado con el estudio que no forme parte de la atención médica habitual. Se entiende que el paciente puede retirar el consentimiento en cualquier momento y sin perjuicio de su atención médica futura.
    E.4Principal exclusion criteria
    - Prior systemic treatment of the WM (plasmapheresis and short ? term administration of corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone is allowed)
    - Patient with hypersensitivity to dexamethasone.
    - Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
    - Uncontrolled bacterial, viral or fungal infection
    - Active HIV, HBV or HCV infection
    - Known interstitial lung disease
    - Prior allergic reaction or severe anaphylactic reaction related to humanized or murine monoclonal antibody.
    - Central Nervous System involvement by lymphoma
    - Prior history of malignancies unless the subject has been free of the disease for >5 years. Exceptions include the following:
    - Basal cell carcinoma of the skin,
    - Squamous cell carcinoma of the skin,
    - Carcinoma in situ of the cervix,
    - Carcinoma in situ of the breast,
    - Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
    - Uncontrolled illness including, but not limited to:
    - Uncontrolled diabetes mellitus (as indicated
    by metabolic derangements and/or severe diabetes mellitus related uncontrolled organ complications)
    - Chronic symptomatic congestive heart failure (Class NYHA III or IV).
    - Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
    - Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
    - Known pericardial disease
    - Subjects with ? Grade 2 neuropathy.
    - Women who are pregnant as well as women who are breast-feeding and do not consent to discontinue breast-feeding.
    - Participation in another clinical trial within 4 weeks before randomization in this study
    - No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
    > Tratamiento sistémico previo de la MW (se permiten plasmaféresis y administración corta de corticosteroides [períodos <4 semanas en dosis equivalente a <20 mg/día de prednisona)
    > Hipersensibilidad a la dexametasona
    > Enfermedad médica o psiquiátrica grave que pueda interferir en el ensayo
    > Infección bacteriana, viral o fúngica no controlada
    > Infección activa por VIH, VHB o VHC
    > Enfermedad pulmonar intersticial conocida
    > Reacción alérgica o anafiláctica grave previa relacionada con anticuerpo monoclonal humanizado o murino.
    > Compromiso del sistema nervioso central por el linfoma (S. de Bing-Neel)
    > Antecedente de enfermedad maligna en la que el sujeto haya estado libre de la enfermedad durante menos de 5 años. Excepciones:
    - Carcinoma de células basales de la piel
    - Carcinoma de células escamosas de la piel
    - El carcinoma in situ del cuello uterino
    - Carcinoma in situ de mama
    - Hallazgo incidental histológico de cáncer de próstata (estadio TNM del T1a o T1b)
    > Enfermedad no controlada, incluyendo, pero no limitado a:
    - Diabetes mellitus no controlada (según lo indicado por las alteraciones metabólicas y / o diabetes mellitus severa relacionada complicaciones de órganos no controlados)
    - Insuficiencia cardíaca congestiva sintomática (NYHA Clase III o IV).
    - Angina de pecho inestable, angioplastia, colocación de stents, o infarto agudo de miocardio en los 6 meses previos a la inclusión
    - Arritmia cardiaca clínicamente significativa (que es sintomática o requiere tratamiento) o taquicardia ventricular asintomática sostenida.
    - Enfermedad pericárdica Conocido
    - Neuropatía ? Grado 2
    > Mujeres embarazadas o mujeres en periodo de amamantamiento que no consienten en interrumpir la lactancia .
    > Participación en otro ensayo clínico dentro de las 4 semanas antes de la asignación al azar en este estudio
    > Ausencia de consentimiento para el registro, almacenamiento y tratamiento de la enfermedad, características y evolución individuales, así como ausencia de información al médico de atención primaria sobre la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the trial is progression-free survival (PFS).
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    LVLS
    Última visita del último sujeto
    E.5.2Secondary end point(s)
    Response rates (CR, VGPR, PR, MR) and overall response rate (ORR) four weeks after the end of induction therapy, best response, time to best response, time to first response, time to treatment failure, remission duration, cause specific survival, overall survival
    Tasa de respuesta (RC, MBRP, RP, RM) y la tasa de respuesta global (RG) a las cuatro semanas de finalizar el tratamiento de inducción, mejor respuesta, tiempo hasta la mejor respuesta, tiempo hasta la primera respuesta, tiempo hasta el fracaso del tratamiento, duración de la remisión, supervivencia específica, supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    LVLS
    Última visita del último sujeto
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparación de DRC solo frente a DRC+Bortezomib
    Comparison of DRC alone vs. DRC+Bortezomib
    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 EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 384
    F.4.2.2In the whole clinical trial 384
    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)
    Further treatment is in the discretion of the treating physician
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GELTAMO
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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