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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2011-001735-22
    Sponsor's Protocol Code Number:CNTO328SMM2001
    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:2011-10-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-001735-22
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects with High-risk Smoldering Multiple Myeloma
    Estudio fase 2, aleatorizado, ciego, controlado con placebo y multicentrico de siltuximab (anticuerpo monoclonal anti-IL-6) en sujetos con Mieloma Múltiple Quiescente de alto riesgo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients with High-risk Smoldering Multiple Myeloma
    Ensayo de Siltuximab (Anticuerpo monoclonal Anti-IL6) en pacientes con mieloma múltiple quiescente de alto riesgo
    A.4.1Sponsor's protocol code numberCNTO328SMM2001
    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.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
    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 AddressJanssen Biologics BV - Clinical Registry Group, Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number31 071 524 21 66
    B.5.5Fax number31 071 524 21 10
    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 nameSiltuximab
    D.3.2Product code CNTO 328
    D.3.4Pharmaceutical form Powder 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 INNSiltuximab
    D.3.9.2Current sponsor codeCNTO328
    D.3.9.3Other descriptive nameanti-IL-6 quimérica murina humana
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeAnticuerpo monoclonal
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High-risk Smoldering Multiple Myeloma
    Mieloma Múltiple quiescente de alto riesgo
    E.1.1.1Medical condition in easily understood language
    Smoldering Multiple Myeloma
    Mileoma Múltiple Quiescente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10028233
    E.1.2Term Multiple myeloma without mention of remission
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate that siltuximab will delay progression of high-risk SMM as measured by the 1 year progression-free survival (PFS) rate.
    El objetivo principal del estudio es demostrar que el siltuximab retardará la progresión del MMQ de alto riesgo, medida por la tasa de supervivencia libre de progresión (SLP) al año.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate additional efficacy measurements including PFS and patient-reported symptoms (patient-reported outcomes [PROs]), as well as safety, pharmacokinetics, antibodies to siltuximab (immunogenicity), and potential biomarkers predictive of response to siltuximab treatment and progression to symptomatic multiple myeloma. Upon progression to multiple myeloma, cytogenetics and response to first subsequent multiple myeloma treatment will be characterized. During an interim analysis, the 6 month progressive disease indicator rate and other endpoints will be evaluated.
    Los objetivos secundarios del estudio son evaluar medidas de eficacia adicionales, incluidas la SLP y los síntomas comunicados por los pacientes (resultados comunicados por los pacientes [RCP]), así como la seguridad, la farmacocinética, los anticuerpos contra el siltuximab (inmunogenicidad) y los posibles biomarcadores predictivos de la respuesta al tratamiento de siltuximab y la progresión a mieloma múltiple sintomático. Cuando se produzca progresión a mieloma múltiple, se caracterizarán la citogenética y la respuesta al primer tratamiento del mieloma múltiple posterior. Durante un análisis intermedio se evaluarán la tasa indicadora de progresión de la enfermedad a los 6 meses y otros criterios de valoración
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of SMM for < 4 years and a diagnosis of high-risk SMM
    2. Patients must be within certain limits for protocol-specified laboratory tests
    3. Eastern Cooperative Oncology Group Performance Status score of 0 or 1
    4. Women of childbearing potential must agree to use adequate birth control measures during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
    5. Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent.
    1. Diagnóstico de MMQ durante < 4 añosy diagnóstico de MMQ de alto riesgo.
    2. El sujeto deberá cumplir ciertos limites de resultados de laboratorio especificados en el protocolo.
    3. Estado funcional ECOG de 0 ó 1 (véase el apéndice 1)
    4. Las mujeres en edad fértil deberán comprometerse a utilizar métodos anticonceptivos adecuados durante el estudio y en los 3 meses siguientes a la última dosis de fármaco del estudio, y deberán tener un resultado negativo en una prueba de embarazo (gonadotropina coriónica humana beta [?-HCG] en suero u orina) en la selección.
    5. Los varones deberán comprometerse a utilizar un método anticonceptivo de doble barrera y a no donar semen durante el estudio y en los 3 meses siguientes a la última dosis de fármaco del estudio.
    E.4Principal exclusion criteria
    1. Having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency,
    symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
    2. Primary systemic AL amyloidosis (a build-up of amyloid light chain proteins in the blood)
    3. Prior or concurrent exposure to approved or investigational multiple myeloma treatments (Concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids are only allowed if given in a stable dose and for a nonmalignant condition. Concurrent treatment with erythropoietin-stimulating agents (ESAs) are not allowed.)
    4. Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor
    5. Other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix
    1. Mieloma múltiple sintomático, definido por cualquiera de los siguientes (si se deben al mieloma):
    a. Lesiones óseas líticas, osteopenia grave o fracturas patológicas
    b. Hipercalcemia (calcio sérico corregido > 11,5 mg/dl)
    c. Insuficiencia renal (creatinina > 2 mg/dl)
    d. Otros: hiperviscosidad sintomática, infecciones bacterianas graves recurrentes como neumonía
    2. Amiloidosis LA primaria sistémica
    3. Exposición previa o concurrente a tratamientos para el mieloma múltiple aprobados o en investigación. Sólo se permite el tratamiento concomitante con fármacos osteoprotectores (p. ej., bisfosfonatos, denosumab) o esteroides si se administran en dosis estable para un proceso no maligno. No se permite el tratamiento concomitante con agentes estimuladores de la eritropoyesis (AEE)
    4. Exposición previa a fármacos dirigidos a la IL-6 o al receptor de la IL-6
    5. Otro tumor maligno en los últimos 3 años, a excepción de los siguientes si se han tratado y no están activos: carcinoma basocelular o escamocelular no metastásico de la piel, carcinoma cervical in situ o carcinoma de cérvix en estadio 1 de la Federación Internacional de Ginecología y Obstetricia (FIGO)
    E.5 End points
    E.5.1Primary end point(s)
    One-year progression-free survival rate (PFS)
    Supervivencia Libre de Progresión al año (SLP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year after randomization of last patient
    Un año después de la aleatorización del último paciente
    E.5.2Secondary end point(s)
    1. Progression-free survivial (PFS)
    2. European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ C30)
    3. Brief Pain Inventory (worst pain item)
    4. Adverse events
    5. Clinical laboratory evaluations
    6. PD indicator rate
    7. Overall survival
    1. Supervivencia Libre de Progresión (SLP)
    2. European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ C30)
    3. Brief Pain Inventory (apartado de peor dolor)
    4. Eventos Adversos
    5. Evaluaciones Clínicas de Laboratorio
    6. Tasa indicadora de progresión
    7. Supervivencia Global
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 4 years after randomization of last patient
    2. Up to approximately 4 years after randomization of last patient
    3. Up to approximately 4 years after randomization of last patient
    4. Up to approximately 4 years after randomization of last patient
    5. Up to approximately 4 years after randomization of last patient
    6. 6 months after randomization of last patient
    7. Approximately 4 years after randomization of last patient
    1. hasta aproximadamente 4 años después de la aleatorización del último paciente.
    2. hasta aproximadamente 4 años después de la aleatorización del último paciente.
    3. hasta aproximadamente 4 años después de la aleatorización del último paciente.
    4. hasta aproximadamente 4 años después de la aleatorización del último paciente.
    5. hasta aproximadamente 4 años después de la aleatorización del último paciente.
    6. 6 meses después de la aleatorización del último paciente.
    7. Aproximadamente 4 años después de la aleatorización del último paciente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Korea, Republic of
    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
    The study will end approximately 4 years after randomization of the last subject or when the sponsor decides to stop the study, and include the End of Treatment Visit 4 weeks after the last study agent administration.
    El estudio finalizará aproximadamente 4 años después de la aleatorización del último paciente o cuando el promotor decida parar el estudio, e incluir la visita de Fin de tratamiento 4 semanas después de la última administración del agente en estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 100
    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)
    Standard of care is no treatment, see protocol
    Esta patología por práctica clínica habitual no recibe tratamiento, ver protocolo
    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 Decision2011-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-21
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