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    The EU Clinical Trials Register currently displays   34947   clinical trials with a EudraCT protocol, of which   5690   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-000454-73
    Sponsor's Protocol Code Number:CC-5013-MDS-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-08
    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 ConcernedSpain - AEMPS
    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 myelodyplastic syndromes (MDS) associated with a deletion (del) 5q[31] cytogenetic abnormality.
    A.4.1Sponsor's protocol code numberCC-5013-MDS-004
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Europe Limited
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive name3-(4’aminoisoindoline-1’-one)-1-piperidine-2, 6-dione
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typeImmunomodulatory agent
    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*
    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
    Transfusion-dependent, low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.
    MedDRA Classification
    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 efficacy of 2 doses of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk (International Prognostic Scoring System [IPSS]) MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.
    E.2.2Secondary objectives of the trial
    To compare the safety of 2 doses of lenalidomide to that of placebo in subjects with RBC transfusion-dependent low- or intermediate-1-risk MDS associated with a del 5q[31] cytogenetic abnormality.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Study population: Pre-Randomization Phase

    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 ≥ 1 week 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.

    Study population: Double-Blind Treatment Phase

    1. Must understand and voluntarily sign an informed consent form
    2. Age ≥ 18 years 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. 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])
    5. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112-days prior to randomization.
    6. Adequate slides of baseline bone marrow aspirate, marrow aspirate iron stain, bone marrow biopsy, and peripheral blood smear have been sent to Central Reviewer
    7. Baseline RBC transfusion requirement has been calculated
    8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

    E.4Principal exclusion criteria
    Study population: 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 (v 3.0) 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 ≥ 3 years
    7. Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
    8. Less than 6 months since prior allogeneic bone marrow transplantation
    9. Less than 3 months since prior autologous bone marrow or stem cell transplantation
    10. Less than 28 days since prior myelosuppressive anticancer biologic therapy
    11. Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
    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

    Study population: Double-Blind Treatment Phase

    1. Pregnant or lactating females
    2. Prior therapy with lenalidomide
    3. Proliferative (WBC ≥ 12,000/mL) CMML
    4. Any of the following laboratory abnormalities:
    - Absolute neutrophil count (ANC) < 500 cells/mL (0.5 x 109/L)
    - Platelet count < 25,000/μL (25 x 109/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)
    - Serum total bilirubin > 1.5 mg/dL
    5. Prior ≥ grade-2 NCI CTCAE allergic reaction to thalidomide
    6. Prior desquamating (blistering) rash while taking thalidomide
    7. Subjects with ≥ grade-2 neuropathy
    8. 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)
    9. 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 ≥ 3 years
    10. Use of androgens other than to treat hypogonadism is prohibited
    11. Known HIV-1 positivity
    12. 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/she participates in the study
    E.5 End points
    E.5.1Primary end point(s)
    RBC transfusion-independence for ≥ 26 weeks (182 days)
    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 Information not present in EudraCT
    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
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2005-09-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 162
    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 Decision2005-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
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