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    Summary
    EudraCT Number:2008-003246-28
    Sponsor's Protocol Code Number:CROB0108/1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-11
    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 number2008-003246-28
    A.3Full title of the trial
    A PILOT STUDY OF LENALIDOMIDE AND DEXAMETHASONE IN PATIENTS WITH PRIMARY PLASMA CELL LEUKEMIA
    STUDIO PILOTA DI LENALIDOMIDE IN ASSOCIAZIONE CON DEXAMETASONE IN PRIMA LINEA IN PAZIENTI CON LEUCEMIA PLASMACELLULARE PRIMITIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    CROB0108/1- - RV-PCL-PI-350
    CROB0108/1- - RV-PCL-PI-350
    A.4.1Sponsor's protocol code numberCROB0108/1
    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 SponsorCENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
    B.1.3.4CountryItaly
    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 Sarl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFO.NE.SA
    B.5.2Functional name of contact pointFondazione Neoplasie Sangue Onlus
    B.5.3 Address:
    B.5.3.1Street AddressDivisione Universitaria di Ematologia Via Genova,3
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number011/6635814
    B.5.5Fax number011/6963737
    B.5.6E-mailgismm2001@yahoo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name REVLIMID
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE Srl
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    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 INNNA
    D.3.9.1CAS number 191732-72-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.3.11.13.1Other medicinal product typeagente immunomodulante
    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 PLASMACELLULARE PRIMITIVA
    E.1.1.1Medical condition in easily understood language
    Primary Plasma Cell Leukemia
    LEUCEMIA PLASMACELLULARE PRIMITIVA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the antitumor activity of the lenalidomide/dexamethasone combination, as first line therapy in patients with PPCL.
    ESPLORARE L'ATTIVITA' ANTITUMORALE DELLA COMBINAZIONE LENALIDOMIDE /DESAMETASONE COME PRIMA LINA DI TERAPIA IN PAZIENTI CON LEUCEMIA PLASMACELLULARE PRIMITIVA
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the lenalidomide/dexamethasone combination in patients with untreated PPCL.
    Valutare la sicurezza e la tollerabilita' della combinazione Lenalidomide /Desametasone in pazienti con LPP non precedentemente trattati.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Voluntarily written informed consent released before any study-related procedure which is not part of normal medical care is performed, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. • Female subjects are either post-menopausal or surgically sterilized or willing to use 2 simultaneous methods of contraception (ie intrauterine devices [IUD] or hormonal contraceptives and one barrier method as latex condoms, diaphragms, cervical caps) throughout the study and for at least 28 days after discontinuation of lenalidomide. • Male patients must agree to use a latex condom during sexual contact with females of childbearing potential throughout the study and for at least 28 days following discontinuation of lenalidomide; they also must agree to abstain from donating blood, semen, or sperm for the whole duration of the study • Patients fulfilling the IMWG diagnostic criteria of PPCL at diagnosis (6) • Patients > 18 years of age • ECOG Performance Status of 0,1 or 2 • Patients with a life expectancy of at least 12 weeks. • Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance.
    1)Consenso informato firmato e datato prima di qualsiasi procedura legata allo studio non facente parte della normale prassi clinica. Il paziente deve aver ben compreso che il suo consenso puo` essere revocato in qualsiasi momento senza che cio` pregiudichi le future cure mediche. 2)Donne potenzialmente fertili, a meno che non siano rispettate tutte le condizioni del Programma di Prevenzione della Gravidanza. Una paziente di sesso femminile o la partner di un paziente di sesso maschile e` considerata in grado di concepire a meno che non rispetti almeno uno dei seguenti criteri: o Eta` ≥ 50 anni e amenorrea naturale* per ≥ 1 anno o Insufficienza ovarica prematura confermata da un ginecologo Precedente salpingo-ovariectomia bilaterale o isterectomia o Genotipo XY, sindrome di Turner, agenesi uterina. 3)I pazienti di sesso maschile devono utilizzare profilattici per l'intera durata del trattamento, durante la sospensione della dose e fino ad almeno 28 giorni dopo l'interruzione della terapia, qualora la propria partner sia in eta` potenzialmente fertile e non utilizzi alcun metodo anticoncezionale. Devono, inoltre, astenersi da donare il sangue, seme o sperme per l'intera durata dello studio. 4)I pazienti devono soddisfare i criteri diagnostici IMWG della LLP alla diagnosi. 5)Pazienti di eta` &gt; 18. 6)ECOG Performance Status di 0,1 o 2 7)Pazienti con un'aspettativa di vita ≥ 12 settimane. 8)I pazienti devono soddisfare una completa valutazione psicosociale e devono essere considerati capaci di ottemperare ai requisiti per partecipare allo studio clinico.
    E.4Principal exclusion criteria
    • Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. • Female subjects either pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women. • Patients have received other investigational drugs with 14 days before enrollment • Serious medical or psychiatric illness likely to interfere with participation in this clinical study. • Patients with renal dysfunction secondary to PPCL may be enrolled at the discretion of the principal investigator. However, patients on hemodialysis or peritoneal dialysis are not eligible. • Patients with a total bilirubin greater than 2.0 mg/dL and SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible. • Patients with active infections are ineligible. • Patients who are HIV positive are ineligible. ‘ • Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous CSF tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. • Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible. • Patients with an ECOG performance status of > 2 are ineligible, however • Patients with an ECOG performance status of 3, secondary to primary disease, may be enrolled at the discretion of the institutional investigator(s).
    • Infarto del miocardio nei 6 mesi precedenti l'inclusione nel presente studio, angina non controllata, aritimia ventricolare severa non controllata, o evidenza ECG di ischemia acuta o anormalita` nel sistema di conduzione attiva. Prima di essere inclusi nello studio, qualsiasi anormalita` ECG allo screening deve essere documentata dal Medico dello studio come non clinicamente rilevante. • Donne in gravidanza o potenzialmente fertili. Conferma che la donna non e` in gravidanza deve essere stabilita dal test β-hCG negativo ottenuto durante il periodo di screening. • I pazienti non devono aver assunto altri farmaci sperimentali nei 14 giorni precedenti l'inclusione nel presente studio. • Severe patologie mediche o psichiatriche che possano interferire con la partecipazione a questi studio clinico. • Pazienti con disfunzione renale secondaria alla LPP possono essere inclusi a discrezione del Medico dello studio. Tuttavia pazienti in emodialisi oppure dialisi peritoneale non sono eleggibili. • Pazienti con: o Bilirubina totale ≥ 2.0 mg/dL. o SGOT o SGPT &gt; 2 ½ il valore normale (a meno che il valore non sia dovuto alla patologia primaria). o Storia di disfunzione epatica severa. • Pazienti con infezioni attive in corso. • Pazienti HIV positivi. • Pazienti con coinvolgimento leptomeningeo. Pazienti con una storia di precedente di coinvolgimento tumorale a livello di liquido cerebrospinale senza segni o sintomi per cui e` disponibile una puntura lombare che dimostri la libera malattia e una RMN evidenzi un non coinvolgimento a livello cerebrale sono eleggibili. • Pazienti con Diabete Mellito insulino-dipendenti o con disfunzione tiroidea o surrenalica non compensate. • Pazienti con un ECOG performance status &gt; 2. • Pazienti con un ECOG performance status di 3, secondario alla patologia in studio, possono essere inclusi a discrezione del Medico dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the response rate according to International Uniform Criteria
    E' la Response Rate (RR) in accordo agli International Uniform Response Criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    To evaluate the safety of the lenalidomide/dexamethasone combination in patients with untreated PPCL.
    Valutare la sicurezza e la tollerabilita' della combinazione Lenalidomide /Desametasone in pazienti con LPP non precedentemente trattati.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 concerned14
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    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 Decision2008-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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