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    Summary
    EudraCT Number:2005-000454-73
    Sponsor's Protocol Code Number:CC-5013-MDS-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-24
    Trial results View 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 number2005-000454-73
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, 3-arm study of the efficacy and safety of 2 doses of Lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent subjects with low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion (DEL) 5q[31] cytogenetic abnormality
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF LENALIDOMIDE VERSUS PLACEBO IN RED BLOOD CELL (RBC) TRANSFUSION-DEPENDENT SUBJECTS WITH LOW- OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES (MDS) ASSOCIATED WITH A DELETION (DEL) 5q[31] CYTOGENETIC ABNORMALITY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if Lenalidomide works in patients with myelodysplastic syndrome and with a special genetic characteristic of the disease, and who need to receive blood transfusion
    Uno studio per valutare se lenalidomide funziona nei pazienti con sindrome mielodisplastica e con una particolare caratteristica genetica della malattia, e che hanno bisogno di ricevere trasfusioni di sangue
    A.4.1Sponsor's protocol code numberCC-5013-MDS-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00179621
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Suite 300, Building 70, Overland Park
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 888 2601599
    B.5.5Fax number001 913 4513459
    B.5.6E-mailClinicalTrialDisclosure@celgene.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*21CPS 5MG
    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 Yes
    D.2.5.1Orphan drug designation numberEU737047192
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    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 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 typeNon Applicabile
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of myelodysplastic syndromes (MDS) associated with deletion 5q cytogenetic abnormality.
    Trattamento delle sindromi mielodisplastiche (SMD) a rischio basso o intermedio associate ad anomalia citogenetica con delezione 5q
    E.1.1.1Medical condition in easily understood language
    Myelosydplastic syndrome is a disorder of the bone marrow, leading to a reduced number of red blood cells. `Deletion 5q[31]` means that the bone-marrow cells presents a certain genetic char
    La sindrome Mielosidiplastica e' una malattia del midollo osseo,con una riduzione di globuli rossi.`Delezione 5q [31]` significa che le cellule midollo osseo hanno caratteristica genetica
    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 HLGT
    E.1.2Classification code 10024324
    E.1.2Term Leukaemias
    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 compare the efficancy of 2 doses of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low or intermiate 1 risk IPPS-MDS associated with a deletion (del) 5q[31] cytogenetic abnormality
    Confrontare l`efficacia di 2 dosi di lenalidomide con quella del placebo in soggetti con SMD associata con anomalia citogenetica da delezione (del) 5q[31] dipendenti da trasfusioni di emazie a categoria di rischio basso o intermedio-1 (secondo International Prognostic Scoring System [IPSS])
    E.2.2Secondary objectives of the trial
    To compare the safety of 2 doses of lenalidomide ti that placebo in subjects with RBC transfusion-dependent low-or intermidiate-1-risk MDS associated with a deletion 5q[31] cytogenetic abnormality
    Confrontare la sicurezza di 2 dosi di lenalidomide con quella del placebo in soggetti con SMD associata con anomalia citogenetica da delezione 5q[31] dipendenti da trasfusione di emazie a categoria di rischio basso o intermedio-1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must understand and voluntarily sign an informed consent form. 2. Must be ≥18 years of age at the time of signing the informed consent form 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Concurrent corticosteroids used for medical conditions other than MDS is allowed provided subject is on a stable or decreasing dose for ≥1week prior to study entry 5. Prior thalidomide allowed 6. Documented diagnosis of MDS that meets IPSS criteria for low- to intermediate-1-risk disease and has an associated del 5q[31] cytogenetic abnormality (the deleted chromosomal region must include 5q[31] 7. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112 days (4 months). Note: A 112 day documented transfusion history is required for subjects to enter the double-blind phase of the study. Double-blind randomization Phase: As point 1-3, 6 and 7 above, plus: 1. Baseline RBC transfusion requirement has been calculated 2. Female subjects of childbearing potential must: - Understand that the study medication could have a potential teratogenic risk - Agree to use, and be able to comply with, effective contraception without interruption, 28 days before starting study drug, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception: implant, Levonorgestrel-releasing intrauterine system, Medroxyprogesterone acetate depot, Tubal sterilisation, Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses, Ovulation inhibitory progesterone-only pills (i.e., desogestrel). - Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 28 days. This requirement also applies to females of childbearing potential who practice complete and continued abstinence. - Agree to have a medically supervised pregnancy test every 28 days including 28 days after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to females of childbearing potential who practice complete and continued abstinence. 8. Male subjects must: - Agree to use condoms throughout study drug therapy, during any dose interruption and for 7 days after cessation of study therapy if their partner is of childbearing potential and has no contraception. - Agree not to donate semen during study drug therapy and for 7 days after end of study drug therapy. 9. All subjects must: - Agree to abstain from donating blood while taking study drug therapy and for 7 days following discontinuation of study drug therapy. - Agree not to share study medication with another person and to return all unused study drug to the investigator
    Fase di pre-randomizzazione: 1. Comprendere e firmare volontariamente il consenso informato. 2. Deve avere compiuto la maggiore eta' al momento della firma del consenso informato 3.Deve aderire allo schema delle visite ed agli altri requisiti del protocollo. 4.E` consentito a condizione l`utilizzo di corticosteroidi concomitanti utilizzati per patologie diverse da MDS, ed e' fornito su una dose stabile o in diminuzione per ≥ 1 settimana prima dell`ingresso nello studio 5.Talidomide permesso 6. 6. Diagnosi documentata di MDS che soddisfa i criteri IPSS a basso a intermedio-1-rischio di malattia e ha associato con delezione 5q [31] anormalita' citogenetica (la regione cromosomica cancellato deve includere 5q [31] 7. RBC anemia trasfusione-dipendente definita come non avere 56 giorni consecutivi senza almeno una trasfusione di RBC immediata di 112 giorni (4 mesi). Nota: Una storia documentata di trasfusione in 112 richiede ai soggetti di entrare nella fase di studio a doppio cieco. Fase di randomizzazione a doppio-cieco: Come ai punti 1,3,6 e 7 sopra, piu': Calcolo alla baseline di una trasfusione RBC Soggetti femmine con possibilita' di avere figli devono: comprendere che i farmaci dello studio possono avere rischi teratogenici potenziali -Essere d`accordo, ed essere compliante, con nell`utilizzo di contraccettivi senza interruzioni, 28 giorni prima di iniziare il farmaco in studio, durante la terapia dello studio (incluso durante la sospensione della terapia) e per 28 giorni dopo la fine della terapia in studio, anche se vi sia amenorrea. Questo e' applicabile a meno che il soggetto si impegni all` astinenza assoluta e continua confermata su base mensile. Sono efficaci i seguenti metodi contracettivi: impianto, rilascio intrauterino di levonorgestrel, medrossiprogesterone acetato di deposito, sterilizzazione delle tube, rapporti sessuali con un partner sesso maschile vasectomizzato; la vasectomia deve essere confermata da due analisi negative del liquido seminale, inibizione dell`ovulazione con pillole di solo progesterone (es. desogestrel). - Concordare nel sottoporsi ad un test di gravidanza sotto controllo medico con una sensibilita' minima del 25 non UI / ml oltre 3 giorni dall`inizio del farmaco in studio una volta che e' stata effettuata una contraccezione efficace per almeno 28 giorni.Questo requisito si applica anche alle femmine in eta' fertile che praticano l`astinenza completa e continua.Concordare di avere un test di gravidanza sotto controllo medico ogni 28 giorni, di cui 28 giorni dopo la fine del trattamento in studio, tranne nel caso di confermata sterilizzazione delle tube. Questi test devono essere effettuati non piu' a 3 giorni prima dell`inizio del trattamento successivo. Tale requisito vale anche per le femmine in eta' fertile che praticano astinenza completa e continuata. 8.I soggetti di sesso maschile devono: - Accettare di usare il preservativo durante la terapia del farmaco in studio, durante qualsiasi interruzione e per 7 giorni dopo la sospensione della terapia in studio se la loro partner e' in eta' fertile e non usa altri metodi di contraccezione. - Impegnarsi a non donare sperma durante la terapia con il farmaco in studio e per 7 giorni dopo la fine del studio della terapia farmacologica. 9. Tutti i soggetti devono: - Essere d`accordo di astenersi dal donare sangue durante l`assunzione di terapia farmacologica in studio e per 7 giorni dopo l`interruzione della terapia farmacologica in studio. - Impegnarsi a non condividere farmaco in studio con un`altra persona e di riportare tutto il farmaco in studio inutilizzato al ricercatore
    E.4Principal exclusion criteria
    Pre-randomization phase: 1. Pregnant or lactating females. 2. Prior therapy with lenalidomide 3. Proliferative (WBC≥12,000/mL) chronic myelomonocytic leukemia (CMML) 4. Prior ≥grade-2 NCI CTCAE allergic reaction to thalidomide 5. Prior desquamating (blistering) rash while taking thalidomide 6. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥3years 7. Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days of Day 1 of the Pre-Randomization Phase. 8. Less than 6 months since prior allogeneic bone marrow transplantation of Day 1 of the Pre-Randomization Phase. 9. Less than 3 months since prior autologous bone marrow or stem cell transplantation of Day 1 of the Pre-Randomization Phase. 10. Less than 28 days since prior myelosuppressive anticancer biologic therapy of Day 1 of the Pre-Randomization Phase. 11. Use of erythropoiesis stimulating growth factors (e.g. recombinant human erythropoietin (rHuEPO) within 28 days or long-acting erythropoiesis stimulating growth factor (e.g. darbepoetin) with 56 days of Day 1 of the Pre-Randomization Phase 12. Use of androgens other than to treat hypogonadism is prohibited. 13. Known HIV-1 positivity 14. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study Double-blind randomization Phase: As points 1-6, 12, 13 and 14 above, plus: 1. Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 500 cells/ μL (0.5 x 10^9/L) - Platelet count < 25,000/μL (25 x 10^9/L) - Serum creatinine > 2.0 mg/dL (177 mmol/L) - Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) unless it is clinically due to iron overload from blood transfusions. - Serum total bilirubin > 1.5 mg/dL 2. Clinically significant anemia owing to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron) E.5 END POINT(S): E.5.1 Primary End Point (repeat as necessary)26 English RBC transfusion independence for ≥ 26 weeks (182 days) E.5.1.1 Timepoint(s) of evaluation of this end point English Up to 52 weeks E.5.2 Secondary End Point (repeat as necessary) English 1.Erythroid response (major and minor according to International MDS Working Group Criteria). 2.Duration of RBC transfusion independence defined to be the number of days between the last transfusion prior to the start of the transfusionfree period and the first transfusion after the transfusion-free period. 3.Change
    Fase di pre-randomizzazione: 1. Gravidanza o allattamento 2. Precedente terapia con lenalidomide 3. Proliferativa (WBC ≥ 12,000 / mL) leucemia cronica mielomonocitica (LMMC) 4. Precedente e di grado ≥-2 NCI CTCAE reazione allergica alla talidomide 5. Precedente desquamazione (veschiche), eruzione cutanea durante l`assunzione di talidomide 6. Storia precedente di tumore maligno diversi MDS (ad eccezione delle cellule basali o carcinoma a cellule squamose o carcinoma in situ della cervice o della mammella)a meno che il soggetto sia stato libero da malattia per ≥ 3 anni 7. L`uso di agenti chemioterapici citotossici o agenti sperimentale (Agenti che non sono disponibili in commercio) per il trattamento delle sindromi mielodisplastiche entro 28 giorni dal giorno 1 della fase di pre-randomizzazione 8. Meno di 6 mesi dal trapianto allogenico di midollo osseo dal di Giorno 1 della fase di pre-randomizzazione. 9.Meno di 3 mesi dal primo trapianto di midollo osseo autologo o cellule staminali al Giorno 1 della fase di pre-randomizzazione. 10. Meno di 28 giorni dalla prima terapia biologica mielosoppressivi antitumorale al Giorno 1 della fase di pre-randomizzazione 11. L`uso di fattori di crescita stimolanti l`eritropoiesi (ad es ricombinante eritropoietina umana (rHuEPO) entro 28 giorni o fattore di crescita stimolanti l`eritropoiesi di lunga durata d`azione(ad es darbepoetina) con 56 giorni dal giorno 1 della fase di prerandomizzazione 12. L`uso di androgeni diversi per il trattamento dell`ipogonadismo e' vietata. 13. Riconosciuto HIV-1 positivo 14. Qualsiasi grave condizione medica o malattia psichiatrica che impedisca il soggetto dal firmare il modulo di consenso informato e pone i soggetti a rischio inaccettabili se partecipa allo studio. Randomizzazione in doppio cieco di fase: Come punti 1-6, 12, 13 e 14, e inoltre: 1. Una qualsiasi delle anomalie di laboratorio: - Conta assoluta dei neutrofili (ANC) &lt;500 cellule / mL (0,5 x 10 ^ 9 / L) - Conta piastrinica &lt;25.000 / mL (25 x 10 ^ 9 / L) - Sierica di creatinina&gt; 2,0 mg / dL (177 mmol / L) - Aspartato aminotransferasi (AST) / siero glutammico-ossalacetica transaminasi (SGOT) o alanina transaminasi (ALT) / glutammato piruvato nel siero transaminasi (SGPT)&gt; 3,0 x limite superiore del normale (ULN) a meno che non sia clinicamente a causa di ferro sovraccarico da trasfusioni di sangue. - Bilirubinemia totale&gt; 1,5 mg / dL 2. Anemia clinicamente significativa al ferro, B12 o folato, o emolisi autoimmune o ereditaria o sanguinamento gastrointestinale (il soggetto deve avere un aspirato midollare che e' valutabile per l`accumulo di ferro) al Giorno 1 della fase di pre-randomizzazione fase
    E.5 End points
    E.5.1Primary end point(s)
    RBC transfusion independence for ≥ 26 weeks (182 days)
    Primario: • Indipendenza da trasfusione di emazie per ≥ 26 settimane (182 giorni) Secondario: • Risposta eritroide (major e minor secondo International MDS Working Group Criteria) • Durata della indipendenza da trasfusione di emazie (definita come il numero di giorni tra l'ultima trasfusione prima dell'inizio del periodo senza trasfusioni e la prima trasfusione dopo il periodo senza trasfusioni). • Variazione rispetto al valore basale della concentrazione di emoglobina (Hb) nel sangue in soggetti che raggiungono una risposta eritroide major • Risposta eritroide a un anno (major e minor secondo International MDS Working Group Criteria). • Variazione rispetto al valore basale della conta piastrinica • Variazione rispetto al valore basale della conta assoluta dei neutrofili • Risposta citogenetica (secondo International MDS Working Group Criteria) • Risposta a livello osteomidollare (secondo International MDS Working Group Criteria) • Sicurezza (tipo, frequenza, e gravita` degli eventi avversi, e relazione con lenalidomide [secondo National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) versione 3.0]) • Valutazioni della qualita` di vita (QoL) [i quattro componenti (fisico, sociale/familiare, benessere emotivo e benessere funzionale (Physical, Social/Family, Emotional and Functional Well-Being)) e tutte le 27 domande di FACT-G, insieme con le 13 domande della sottoscala relativa alla fatica (fatigue subscale), tutti gli argomenti aggiuntivi (Additional Concerns), e tutte le domande del FACT-An (le domande FACT-G piu` le domande sotto il titolo Argomenti Aggiuntivi (Additional Concerns)] e il questionario EQ-5D (solo alla visita iniziale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 52 weeks
    sino a 52 settimane
    E.5.2Secondary end point(s)
    1.Erythroid response (major and minor according to International MDS Working Group Criteria). 2.Duration of RBC transfusion independence defined to be the number of days between the last transfusion prior to the start of the transfusionfree period and the first transfusion after the transfusion-free period. 3.Change of blood hemoglobin (Hb) concentration from baseline in subjects who achieve a major erythroid response 4.Erythroid response (major and minor according to International MDS Working Group Criteria) at one year. 5.Change in platelet counts from baseline 6.Change in absolute neutrophil counts from baseline 7.Cytogenetic response (according to the International MDS Working Group Criteria) XML File Identifier: H8eo/LWbtE2ovPk0R5KxkXzZq9M= Page 13/24 8.Bone marrow response (according to the International MDS Working Group Criteria) 9.Safety (type, frequency, and severity [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0] of adverse events (AEs), and relationship of AEs to lenalidomide) 10.Quality of Life (QoL) assessments: [the four components (Physical, Social/Family, Emotional and Functional Well-Being) and total of the 27-item FACT-G, together with the 13-item fatigue subscale, the total of the Additional Concerns, and the total of all items on the FACT-An (the FACT-G items plus the items under Additional Concerns} and EQ-5D [at initial visit only]) 11.Overall Survival (OS) 12.Time to Acute Myeloid Leukemia (AML) Transformation
    1.Risposta ad Erythroid (maggiori e minori in base alle indicazioni del International MDS Working Group Criteria). 2.Tempo di durata indipendente da trasfusioni di eritrociti definito come il numero di giorni tra l`ultima trasfusione e prima dell`inizio del periodo libero da transfusioni e la prima trasfusione dopo il periodo libero dalla trasfusione. 3.Modificare la concentrazione di emoglobina (Hb)rispetto al basale in soggetti che ottengano una risposta importante con eritroide 4.Risposta ad Erythroid (maggiori e minori in base alle indicazioni dell` MDS International Working Group) ad un anno. 5.Cambiamento della conta piastrinica al basale 6. Modifica nella conta assoluta dei neutrofili rispetto ai valori basali 7. Risposta Cytogenetica (secondo l`MDS MDS International Working Group) 8.Risposta al midollo osseo secondo i criteri dell`International MDS Working group) 9.Safety (tipo, frequenza e gravita' [National Cancer Institute (NCI)Common Criteri Terminologia per Eventi Avversi (CTCAE) versione 3.0] di eventi avversi(EA), e la relazione di eventi avversi a lenalidomide) 10.Qualita' della Vita (QoL) valutazioni: [i quattro componenti (fisica, Sociale / famiglia, Emozionale e funzionale Benessere) e totale dei 27-item FACT-G, insieme alla fatica sottoscala 13-item, il totale delle preoccupazioni aggiuntive, e il totale di tutti i punti all`ordine del FACT-An (il FACT-G articoli piu' le voci sotto supplementare Preoccupazioni} e EQ-5D [alla visita iniziale solo]) 11.Overall sopravvivenza (OS) 12.Time di leucemia mieloide acuta (LMA) Trasformazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 52 weeks 2. Up to 52 weeks 3. Baseline, up to 52 weeks 4. up to 52 weeks 5. up to 52 weeks 6. up to week 52 7. up to 52 weeks 8. up to 52 weeks 9. up to week 52 10. Baseline, Week 12 11. up to 3 years after the last subject has completed/discontinued from the open-label phase 12. up to 3 years after the last subject has completed/discontinued from the open-label phase
    1. Fino a 52 settimane 2. Fino a 52 settimane 3. Baseline, fino a 52 settimane 4. fino a 52 settimane 5. fino a 52 settimane 6. fino alla settimana 52 7. fino a 52 settimane 8. fino a 52 settimane 9. fino alla settimana 52 10. Baseline, settimana 12 11. fino a 3 anni dopo che l`ultimo soggetto ha completato / dismessi da la fase in aperto 12. fino a 3 anni dopo che l`ultimo soggetto ha completato / dismessi dalla fase in aperto
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    additional open-label extension phase
    additional open-label extension phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    see protocol
    vedere il protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.1Number 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.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 123
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-24. Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 205
    F.4.2.2In the whole clinical trial 205
    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)
    After end of participation in the trial, patients will go back to their physician. Treatment they will be given remains at the discretion of their physician.
    Dopo la fine della partecipazione dello studio, i pazienti torneranno dal loro meidco. Il trattamento che gli verra' data rimane a discrezione del loro medico.
    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 Decision2005-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-20
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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