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    Clinical Trial Results:
    THE EFFICACY AND SAFETY OF LENALIDOMIDE (Revlimid®) MONOTHERAPY IN RED BLOOD CELL TRANSFUSION DEPENDENT SUBJECTS WITH MYELODYSPLASTIC SYNDROME ASSOCIATED WITH A DEL (5q) CYTOGENETIC ABNORMALITY

    Summary
    EudraCT number
    2004-005101-29
    Trial protocol
    GB  
    Global end of trial date
    23 May 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions
    Summary report(s)
    RESULTS SUMMARY

    Trial information

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    Trial identification
    Sponsor protocol code
    KCH-MDS-04-1.0
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00874978
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College Hospital
    Sponsor organisation address
    Denmark Hill , London, United Kingdom, SE5 9RS
    Public contact
    Professor Ghulam Mufti, King's College Hospital NHS Foundation Trust, 0044 0203299 3080, ghulam.mufti@kcl.ac.uk
    Scientific contact
    Professor Ghulam Mufti, King's College Hospital NHS Foundation Trust, 0044 0203299 3080, ghulam.mufti@kcl.ac.uk
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor Ghulam Mufti, King's College London, 0044 02032993080, ghulam.mufti@kcl.ac.uk
    Scientific contact
    Professor Ghulam Mufti, King's College London, 0044 02032993080, ghulam.mufti@kcl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del 5q cytogenetic abnormality To evaluate the efficacy of lenalidomide to achieve haematopoietic improvement in patients with isolated del5q with blasts <20%
    Protection of trial subjects
    Forty eight (48) subjects with a diagnosis of low- or intermediate-1 risk MDS associated with a del 5(q) cytogenetic abnormality or isolated del5(q) patients with up to 20% blasts, who are RBC transfusion-dependent and meet all the eligibility criteria will be enrolled into the study
    Background therapy
    None
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    03 Jan 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    23
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from one clinical site in the UK betweek 2005 and 2016

    Pre-assignment
    Screening details
    Aged 18 or over with diagnosis of low- or intermediate-1-risk (IPSS) MDS with a del(5q) cytogenetic abnormality which may be an isolated finding or may be associated with other cytogenetic abnormalities & if del5(q) is an isolated aberration the patient could have up to 20% blasts

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This study is a single centre, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion dependent subjects with IPSS low- or intermediate-1 risk MDS associated with a del5(q) cytogenetic abnormality and also in patients with isolated del5q with blasts <20%.

    Arms
    Arm title
    Overall Trial
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Revlimid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Oral lenalidomide 10mg (two 5mg capsules) daily on Days 1-21 every 28 days for up to 12 cycles or until bone marrow disease progression or progression/relapse following erythroid haematologic improvement (Appendix 2). At the end of 12 cycles, if there is erythroid haematologic improvement, subjects will receive further cycles until bone marrow disease progression or progression/relapse.

    Number of subjects in period 1
    Overall Trial
    Started
    44
    Completed
    36
    Not completed
    8
         Adverse event, serious fatal
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    44 44
    Age categorical
    Units: Subjects
        Adults (18-70 years)
    25 25
        Adults (71-80years)
    15 15
        81 years and over
    4 4
    Gender categorical
    Units: Subjects
        Female
    29 29
        Male
    15 15

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Primary: Primary

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    End point title
    Primary [1]
    End point description
    To evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System[1] (IPSS) myelodysplastic syndrome (MDS) associated with a del 5(q) cytogenetic abnormality.  To evaluate the efficacy of lenalidomide to achieve haematopoietic improvement in patients with isolated del5q with blasts <20%
    End point type
    Primary
    End point timeframe
    During 12 cycles of treatment (12 months). Each cycle lasts 28 days.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see attached document.
    End point values
    Overall Trial
    Number of subjects analysed
    36
    Units: Whole
    36
    No statistical analyses for this end point

    Secondary: Secondary

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    End point title
    Secondary
    End point description
    End point type
    Secondary
    End point timeframe
    Through 12 cycles of treatment with Revlimid. (each cycle lasting 28 days).
    End point values
    Overall Trial
    Number of subjects analysed
    36
    Units: Whole
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days + 2 days after last IMP dose
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Serious adverse events
    Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 44 (40.91%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma hand
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Irreguglar pulse requiring pacemaker
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myopericarditis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bilateral pleural effesions
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Chest Infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infective exacerbation of COPD
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest sepsis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neutropenia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    MDS disease progression
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Anaemia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fall
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower back pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Loss of appetite
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Left knee pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Diverticulitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Peri-anal abcess
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin rash
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Scrotal swelling
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Localised infection & disease progression
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis - (Stenotrophomonas maltropilila)
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Finger infetion
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Loclised infection of hand and elbow
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 44 (84.09%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    3
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    6
    Respiratory, thoracic and mediastinal disorders
    Chest infection
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    14
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 44 (38.64%)
         occurrences all number
    24
    Shortness of breath
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    6
    Eye disorders
    Eye infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 44 (29.55%)
         occurrences all number
    15
    Headache
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    16 / 44 (36.36%)
         occurrences all number
    30
    Constipation
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    11
    Abdominal pain
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Dental Infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Mucositis oral
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Renal and urinary disorders
    Urine infection
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    20 / 44 (45.45%)
         occurrences all number
    35
    Dry skin
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    11
    Cellulitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    5
    Neck pain
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Apr 2010
    1) Clarification of co-sponsor arrangements between King’s College Hospital NHS Foundation Trust and King’s College London . 2) The investigational medicinal product, lenalidomide, supply beyond the 12 month study phase until patients show disease progression, toxicity or a decline in response. 3) The sensitivity and time points for conducting the pregnancy tests and the birth control section altered in line with Celgene’s most recent Pregnancy Prevention Programme for Investigator Initiated Trials in the European Union. 4) Follow up for patients who discontinue from study drug clarified in the protocol. 5) Change of Revlimid status from unlicensed product to confirmation of market authorisation.
    19 Sep 2012
    1) Change to the inclusion criteria to include patients with MDS and isolated del5q with blasts <20%. 2) Changes to the primary and secondary endpoints and study design in relation to the inclusion of patients with isolated del5q with blasts <20%. 3) Change in sample size from 36 to 48 patients The protocol has been updated to reflect the changes mentioned above with further administrative changes. The administrative changes include an update to the protocol appendix 4 Pregnancy Testing Guidelines and Acceptable Birth Control Methods, change in department name from Joint Clinical Trials Office to King’s Health Partners Clinical Trials Office and change in the address for Celgene.
    29 Jul 2013
    1) Change in the packaging of the IMP from bottled supply to blister pack 2) Change in the site where QP certified batch release

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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