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    Summary
    EudraCT Number:2005-000454-73
    Sponsor's Protocol Code Number:CC-5013-MDS-004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-000454-73
    A.3Full title of the trial
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 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
    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 pointClinicalTrialDisclosure
    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 number+18882601599
    B.5.5Fax number+19134513459
    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 5mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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, 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 No
    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
    Transfusion-dependant, low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality
    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 present a certain genetic characteristic
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 intermdiate-1-risk (International Prognosis 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 intermdiate-1-risk MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 ≥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
    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 points
    E.5.1Primary end point(s)
    RBC transfusion independence for ≥ 26 weeks (182 days)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 52 weeks
    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 transfusion-free 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)
    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
    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
    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
    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.8.2.4Number 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 concerned8
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    France
    Germany
    Israel
    Italy
    Spain
    Sweden
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 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 2005-02-23. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    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.
    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 Decision2005-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-20
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