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    Summary
    EudraCT Number:2017-004592-31
    Sponsor's Protocol Code Number:APIXABAN
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-04
    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 number2017-004592-31
    A.3Full title of the trial
    Venous Thromboembolism Prophylaxis with Apixaban in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Receiving Induction Therapy with an Immunomodulatory-Based Regimen
    Profilaxis tromboembólica con apixabán en pacientes con mieloma múltiple de nuevo diagnóstico candidatos a trasplante que van a recibir regímenes de tratamiento basados en fármacos inmunomoduladores
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Venous Thromboembolism Prophylaxis with Apixaban in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Receiving Induction Therapy with an Immunomodulatory-Based Regimen
    Profilaxis tromboembólica con apixabán en pacientes con mieloma múltiple de nuevo diagnóstico candidatos a trasplante que van a recibir regímenes de tratamiento basados en fármacos inmunomoduladores
    A.4.1Sponsor's protocol code numberAPIXABAN
    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 SponsorHealth Research Institute Hospital La Fe
    B.1.3.4CountrySpain
    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 supportBristol-Myers Squibb
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHealth Research Institute Hospital La Fe
    B.5.2Functional name of contact pointMaria Cortell
    B.5.3 Address:
    B.5.3.1Street AddressAv. Fernando Abril Martorell, 106
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.4Telephone number0034961246611
    B.5.6E-mailinvestigacion_clinica@iislafe.es
    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 Apixaban (BMS-562247) film coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road
    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.3.4Pharmaceutical form Coated 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 INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeBMS-562247
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Venous Thromboembolism (VTE) prophylaxis
    Profilaxis del tromboembolismo venoso
    E.1.1.1Medical condition in easily understood language
    Venous Thromboembolism prophylaxis
    Profilaxis del tromboembolismo venoso
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    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 this study is to evaluate the feasibility of apixaban 2.5 mg given twice daily for the prevention of VTE during induction therapy with VTD in a series of patients with newly diagnosed multiple myeloma considered to be transplant-eligible.
    Evaluar la eficacia del apixabán en la prevención de la ETV durante el tratamiento de inducción con VTD en pacientes candidatos a trasplante con mieloma múltiple de nuevo diagnóstico.
    E.2.2Secondary objectives of the trial
    To analyze the safety and tolerability of apixaban 2.5 mg given twice daily during induction therapy with VTD. For this purpose, either major bleeding or clinically relevant non-major (CRNM) bleeding and any grade III or higher adverse events related to the study drug will be collected during the study period.
    Evaluar tanto el sangrado grave como el no grave pero clínicamente relevante, así como cualquier efecto adverso grado III o superior relacionado con el fármaco del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed written informed consent:
    • Each subject, or their legally acceptable representative, must sign an informed consent form indicating that he or she understands the purpose and procedures required for the study, and are willing to participate in the study. Consent to participate in the study will be obtained prior to screening.
    Target population:
    • Subjects must have documented newly diagnosed symptomatic multiple myeloma requiring front-line treatment.
    • Patients should be considered transplant-eligible.
    • Subjects will receive front-line induction therapy with a triplet regimen consisting of bortezomib, thalidomide and dexamethasone (VTD).
    • To enter to the study at the same time of start anti myeloma induction therapy.
    Patient features:
    • Ages eligible for study: 18 to 70 years.
    • Genders eligible for study: both.
    • Race eligible for study: any.
    • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
    - Edad: entre 18 y 70 años.
    - Sexos: ambos.
    - El paciente debe tener un Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
    - Cada sujeto (o su representante legal) deben firmar el consentimiento informado (CI) indicando que él o ella entienden el objetivo y procedimientos del estudio, y que están de acuerdo en participar en el estudio.
    - Los pacientes deberán ser diagnosticados de novo de mieloma múltiple sintomático y recibir tratamiento efectivo.
    - Ser considerados como candidatos a trasplante.
    E.4Principal exclusion criteria
    Target population exceptions:
    • Patients with the diagnosis of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or amyloidosis of light chain.
    • Patients with smouldering multiple myeloma or monoclonal gammopathy of undeterminated significance.
    • Patients considered non-transplant-eligible.
    Medical history and concurrent diseases:
    • Grade ≥2 of peripheral neuropathy.
    • Prior history of documented any venous thromboembolism and arterial thrombosis event.
    • Active or high risk of bleeding.
    • Need for on-going anticoagulant or antiplatelet treatment.
    • Contraindication of anticoagulant prophylaxis.
    • Uncontrolled hypertension: systolic blood pressure >200 mmHg and/or diastolic blood pressure >100 mmHg.
    • HIV, HBV or HCV-positive active.
    • Expected survival <6 months.
    • Weight <40 Kg.
    • Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin, or other oral anticoagulants.
    Laboratory test findings:
    • Low platelet count (<50 x109/L).
    • ALT >3x UNL, bilirubin >2x ULN.
    • Creatinine clearance <30 mL/min.
    Sex and reproductive status:
    • Women of childbearing potential who are unwilling to use an acceptable method of contraception.
    • Women of childbearing potential who are pregnant or breastfeeding.
    • Women with a positive pregnancy test on enrollment, prior to investigational product administration.
    Other exclusion criteria:
    • Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study.
    • Subjects unwilling or unable to comply with study medication instructions or study procedures (e.g. bilateral lower extremity venous ultrasonography).
    • Known allergies to ingredients contained in apixaban.
    • Use of any contraindicated medications with apixaban (see section 5.4.1).
    - Pacientes diagnosticados de leucemia de células plasmáticas, macroglobulinemia de Waldeström, síndrome POEMS o amiloidosis de cadenas ligeras.
    - Tener un MM asintomático o una gammapatía monoclonal de significado incierto.
    - Haber recibido alguna línea de tratamiento previa para el MM antes de la entrada en el estudio.
    - No ser considerados como candidatos a trasplante.
    - Mujeres en edad fértil que no aceptan utilizar un método anticonceptivo eficaz, o que están embarazadas o en lactancia materna activa.
    - Grado ≥2 de neuropatía periférica.
    - Historia previa de ETV documentada.
    - Hemorragia activa o alto riesgo de sangrado.
    - Necesidad de tratamiento anticoagulante o antiagregante.
    - Contraindicación para la profilaxis anticoagulante.
    - Supervivencia estimada inferior a 6 meses.
    - Trombocitopenia moderada (<50 x109/L).
    - ALT >3x o bilirrubina >2x del valor superior de la normalidad.
    - Aclaramiento de creatinina <30 mL/min.
    - Hipertensión arterial mal controlada (tensión arterial sistólica >200 mmHg y/o tensión arterial diastólica >100 mmHg).
    - Serologías positivas para VIH, VHB y/o VHC.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy outcomes will include:
    • VTE-related death (i.e. death for which VTE can not be excluded as a cause).
    • Symptomatic DVT.
    • Fatal or non-fatal pulmonary embolism.
    • Asymptomatic proximal DVT as detected by systematic compression ultrasound.
    Eficacia del tratamiento, definida como el conjunto de:
    - Trombosis venosa profunda (tanto sintomática como asintomática detectada en los controles con eco-doppler venoso de miembros inferiores).
    - Embolismo pulmonar.
    - Muerte relacionada con los eventos tromboembólicos.
    - Infarto agudo de miocardio.
    - Accidente cerebrovascular isquémico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)
    Durante la terapia de inducción con VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 días tras EOT, 28 días tras EOT)
    E.5.2Secondary end point(s)
    - Additional secondary efficacy outcomes will include:

    • The composite of total VTE and VTE-related death occurring up to the time of discontinuation of blinded parenteral therapy.
    • Symptomatic DVT or non-fatal PE occurring during the 60 day follow-up period.
    • All cause mortality occurring during 30 days of the study.
    • All cause mortality during the 90 day period of the study.
    Secondary efficacy outcomes will also be adjudicated by the ICAC.

    - Demographics and baseline characteristics:

    Frequency distributions and summary statistics for demographic and baseline variables will be presented for all subjects. Key demographic and baseline variables to be summarized include: geographic region, age, gender, race, height, weight, body mass index, vital signs (systolic blood pressure, diastolic blood pressure, and heart rate), medical history, previous VTE. The summary will be presented for all subjects.

    - Safety analyses:

    The incidence of adjudicated major bleeding events during the treatment period will be summarized. Point estimates with 95% confidence intervals will be presented. The incidence of adjudicated clinically relevant non-major bleeding events during the treatment period will also be summarized, as well as the incidence of the adjudicated composite endpoint of major bleeds or clinical relevant non-major bleeds during the treatment period.
    The incidence of the composite of adjudicated acute MI and acute stroke during the treatment period and follow up period (60 days after the last dose of study medication) will be summarized.
    The incidence of adverse events and of marked abnormalities in clinical lab tests will be summarized. All adverse events that are serious or that result in discontinuation of study therapy will be described in depth
    Los resultados de eficacia secundarios adicionales incluirán:

    • El compuesto de muerte total relacionada con TEV y TEV hasta el momento de la interrupción del tratamiento parenteral ciego.
    • TVP sintomática o EP no fatal que ocurra durante el período de seguimiento de 60 días.
    • Mortalidad por todas las causas que ocurra durante los 30 días del estudio.
    • Mortalidad por todas las causas durante el período de 90 días del estudio.
    Los resultados secundarios de eficacia también serán adjudicados por el ICAC.

    - Características demográficas y de base:

    Se presentarán distribuciones de frecuencia y estadísticas de resumen para las variables demográficas y de referencia para todas las asignaturas. Las principales variables demográficas y de referencia que se resumirán son: región geográfica, edad, sexo, raza, altura, peso, índice de masa corporal, signos vitales (presión arterial sistólica, presión arterial diastólica y frecuencia cardíaca), historial médico, TEV previo. El resumen será presentado para todas las materias.

    - Análisis de seguridad:

    Se resumirá la incidencia de eventos hemorrágicos mayores adjudicados durante el período de tratamiento. Se presentarán estimaciones puntuales con intervalos de confianza del 95%. También se resumirá la incidencia de episodios hemorrágicos no graves clínicamente relevantes adjudicados durante el período de tratamiento, así como la incidencia de la variable combinada adjudicada de hemorragias graves o hemorragias no importantes relevantes clínicas durante el período de tratamiento.
    Se resumirá la incidencia del compuesto de infarto agudo de miocardio adjudicado y accidente cerebrovascular agudo durante el período de tratamiento y el período de seguimiento (60 días después de la última dosis de la medicación del estudio).
    Se resumirá la incidencia de eventos adversos y de anormalidades marcadas en las pruebas de laboratorio clínico. Todos los eventos adversos que son graves o que resultan en la interrupción de la terapia del estudio se describirán en profundidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)
    Durante la terapia de inducción con VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 días tras EOT, 28 días tras EOT)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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 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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects incapable of giving consent for physiological reasons, or reasons linked to their medical condition (e.g. mental disability)
    Subjects who don't know how to read
    Subjects who don't know the language
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    None
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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