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    Summary
    EudraCT Number:2013-005157-75
    Sponsor's Protocol Code Number:EMN12/HO129PCL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005157-75
    A.3Full title of the trial
    Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
    TRATTAMENTO DI CARFILZOMIB E LENALIDOMIDE PER I PAZIENTI GIOVANI E PER I PAZIENTI ANZIANI DI NUOVA DIAGNOSI AFFETTI DA LEUCEMIA PLASMACELLULARE PRIMARIA (pPCL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
    TRATTAMENTO CON CARFILZOMIB E LENALIDOMIDE PER I PAZIENTI GIOVANI E ANZIANI AFFETTI DA LEUCEMIA PLASMACELLULARE PRIMARIA ALLA DIAGNOSI
    A.3.2Name or abbreviated title of the trial where available
    EMN12/HO129 PCL
    EMN12/HO129 PCL
    A.4.1Sponsor's protocol code numberEMN12/HO129PCL
    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 SponsorHOVON
    B.1.3.4CountryNetherlands
    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 supportCelgene International
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportOnyx Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOVON
    B.5.2Functional name of contact pointHOVON Data Center
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310107041560
    B.5.5Fax number+310107041028
    B.5.6E-mailhdc@erasmusmc.nl
    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 KYPROLIS
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNCARFILZOMIB
    D.3.9.1CAS number 868540-17-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 REVLIMID - 5 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CASPULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.1Product nameREVLIMID
    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 INN00309600
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 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 REVLIMID - 10 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INN00309600
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 REVLIMID - 15 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INN00309600
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 REVLIMID - 25 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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 INN00309600
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Primary plasma cell leukemia
    Leucemia Plasma Cellulare
    E.1.1.1Medical condition in easily understood language
    Primary plasma cell leukemia
    Leucemia Plasma Cellulare
    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 10035223
    E.1.2Term Plasma cell leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate progression-free survival in adult pPCL patients by incorporation of carfilzomib and lenalidomide in induction, consolidation, and maintenance therapy
    Valutare la sopravvivenza libera da progressione nei pazienti adulti con PPCL trattati con carfilzomib e lenalidomide durante il trattamento di induzione, di consolidamento e di mantenimento.
    E.2.2Secondary objectives of the trial
    - To assess overall response rate and (s)CR + VGPR ((stringent) complete and very good partial response) rate after induction therapy, after HDM, after CRd consolidation, after RIC allo-SCT or a second HDM, and during maintenance.
    - To evaluate overall survival.
    - To assess safety and toxicity
    - To assess the prognostic value of risk factors at diagnosis, including
    ¿2-microglobulin, LDH, FISH abnormalities del1p, ampli 1q, t(4;14), t(14;16), t(11;14), ampli 9, del13q/13-, del17p as analyzed in purified bone marrow plasma cells with respect to progression-free survival
    - To analyze the prognostic value of myeloma gene expression profiles
    - To analyze the prognostic value of minimal-residual disease negativity
    - To assess the prognostic value of mutations as determined by sequencing
    - To analyze the prognostic value of minimal-residual disease negativity
    - To establish the frequency of second primary malignancies (SPM)
    - Valutare la percentuale di risposta globale e (s)CR + VGPR (risposta completa (stringente) e risposta parziale molto buona) dopo la terapia di induzione, dopo HDM, dopo il consolidamento con CRd, dopo RIC allo-SCT o un secondo HDM, e durante il mantenimento.
    - Valutare la sopravvivenza globale
    - Valutare la sicurezza e le tossicit¿
    - Valutare il valore prognostico dei fattori di rischio alla diagnosi, inclusi ¿2-microglobulina, LDH, le anormalit¿ del1p, ampli 1q, t(4;14), t(14;16), t(11;14), ampli 9, del13q/13-, del17p tramite FISH, analizzando le plasmacellule del midollo osseo purificate, in relazione alla sopravvivenza libera da progressione
    - Analizzare il valore prognostico dei profili d¿espressione genetica del mieloma
    - Analizzare il valore prognostico della negativit¿ della malattia minima residua
    - Analizzare il valore prognostico delle mutazioni come determinato dal sequenziamento
    - Stabilire la frequenza dei secondi tumori primari (SPM)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with diagnosis of symptomatic pPCL (see appendix A)
    - Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 10 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
    - Age =18 years
    - WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL and not by co-morbid conditions)
    - Written informed consent
    - Patient capable of giving informed consent (patient is legally, physically and mentally capable of giving consent)
    - All men and women of childbearing potential should use adequate contraception during the study. Sperm could be frozen from men with child wish before start of treatment
    - Negative pregnancy test at entry (if applicable)
    - Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program (PPP)
    - Pazienti con diagnosi di PPCL sintomatica (vedi appendice A)
    - Malattia misurabile definita dalla presenza della proteina M nel siero o nelle urine (siero proteina M> 10 g/l o nelle urine proteina M> 200 mg/24 o rapporto anormale delle catene libere leggere con catene libere leggere (FLC)> 100 mg/l) o accertato plasmacitoma da biopsia
    - Età =18 anni
    - WHO performance status 0-3 (WHO = 3 è consentito solo quando è causato da PPCL e non da comorbidità concomitanti)
    - Consenso informato scritto
    - Paziente in grado di dare un consenso informato (paziente è legalmente, fisicamente e mentalmente in grado di dare il consenso)
    - Tutti gli uomini e le donne in età fertile devono utilizzare un adeguato metodo contraccettivo durante lo studio. Lo sperma potrebbe essere congelato per gli uomini che hanno desiderio di avere un bambino, prima dell'inizio del trattamento
    - Test di gravidanza negativo all'inizio dello studio (se applicabile)
    - Il paziente deve essere disposto e in grado di rispettare i requisiti del Programma di Prevenzione della Gravidanza per la lenalidomide (PPP)
    E.4Principal exclusion criteria
    - Any current CNS involvement with disease refractory to intrathecal chemotherapy.
    - Female patients who are pregnant or breast feeding.
    - HIV positive patients
    - Active malignancy other than pPCL requiring treatment, or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
    - Patients with active, uncontrolled infections
    - Severe neurological or psychiatric disease
    - Severe cardiac dysfunction (NYHA classification II-IV, see appendix E)
    - Severe pulmonary dysfunction
    - Significant hepatic dysfunction (serum bilirubin or transaminases = 3.0
    times normal level), unless related to pPCL
    - Patients with GFR < 15 ml/min
    - Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize carfilzomib)
    - Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days
    for symptom control or stabilization(this includes dexamethasone 40 mg daily) or inthrathecal chemotherapy in case of CNS involvement
    - Systemic AL amyloidosis
    - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    - Qualsiasi attuale coinvolgimento del sistema nervoso centrale con malattia refrattaria alla chemioterapia intratecale.
    - Donne in gravidanza o in allattamento.
    - Pazienti HIV positivi
    - Tumore maligno attivo diverso da PPCL che richiede trattamento, o un tumore maligno che è stato trattato con chemioterapia che colpisce attualmente la capacità del midollo osseo
    - Pazienti con infezioni non controllate, attive
    - Malattia neurologica o psichiatrica grave
    - Grave disfunzione cardiaca (NYHA classificazione II-IV, vedi appendice E)
    - Disfunzione polmonare grave
    - Disfunzione epatica significativa (bilirubina sierica o transaminasi = 3.0 volte del livello normale), a meno che non sia correlata a PPCL
    - Pazienti con GFR <15 ml / min
    - Storia nota di allergia a Capsidol (un derivato ciclodestrina usato per solubilizzare carfilzomib)
    - Precedente chemioterapia o radioterapia, ad eccezione della radioterapia locale in caso di progressione di mieloma locae o corticosteroidi massimo 7 giorni per il controllo dei sintomi o la stabilizzazione (questo include desametasone 40 mg al giorno) o chemioterapia intratecale in caso di coinvolgimento del sistema nervoso centrale
    - Amiloidosi AL Sistemica
    - Qualsiasi condizione psicologica, familiare, sociologica e geografica che potrebbe potenzialmente ostacolare il rispetto del protocollo di studio e la pianificazione di follow-up
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS, i.e. time from registration until progression or death, whichever comes first).
    La sopravvivenza libera da progressione (PFS, cioè il tempo dalla registrazione fino alla progressione o morte, qualunque sia l'evento che si verifica per primo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial. After last patient has completed maintenance treatment.
    Alla fine dello studio. Dopo che l'ultimo paziente ha completato il trattamento di mantenimento.
    E.5.2Secondary end point(s)
    - Overall response rate (at least PR) after the different phases of treatment
    - (s)CR + VGPR ((stringent) complete and very good partial response) after the different phases of treatment
    - Overall survival, defined as time from registration until death from any cause. Patients still alive at the date of last contact, will be censored
    - Toxicity and tolerability of the different phases of treatment
    - Explore the value of prognostic factors including including FISH abnormalities, ¿2-microgloublin, LDH, MRD-negativity, pPCL gene expression profiles and sequencing results on the overall response, overall survival and progression¿free survival
    - Frequency of second primary malignancies
    - La percentuale di risposta (almeno PR) dopo le varie fasi di trattamento
    - (s)CR + VGPR ((severe) risposta completa e risposta parziale molto buona)
    - Sopravvivenza globale, definita come il tempo dalla registrazione fino alla morte per qualsiasi causa. I pazienti ancora in vita alla data dell'ultimo contatto, saranno censurati
    - Tossicit¿ e tollerabilit¿ delle varie fasi di trattamento
    - Valutare il ruolo dei fattori prognostici, tra cui le anomalie FISH, ¿2-microglobulina, LDH, negativit¿ MRD, profili di espressione genica di PPCL e risultati sequenziamento nella risposta complessiva, la sopravvivenza globale e la sopravvivenza libera da progressione.
    - Frequenza di secondi tumori primari
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial. After last patient has completed maintenance treatment.
    Alla fine dello studio. Dopo che l'ultimo paziente ha completato il trattamento di mantenimento.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    stratificazione in base all'et¿ del paziente
    stratification based on age of patient
    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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Denmark
    Germany
    Italy
    Netherlands
    Norway
    Sweden
    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
    LVLS
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 61
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 116
    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)
    patients will be followed by their physician to the end of the study.
    I pazienti verranno seguiti dal proprio medico al termine della partecipazione allo studio.
    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 Decision2016-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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