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    Clinical Trial Results:
    A Phase 2, Prospective, Randomized, Multicenter, Double-blind, Active-control, Parallel-group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 (Pomalidomide) Either as Single-agent or in Combination With Prednisone to Study Further in Subjects With Myelofibrosis With Myeloid Metaplasia

    Summary
    EudraCT number
    2006-004553-17
    Trial protocol
    GB   ES   AT   IT   DE  
    Global end of trial date
    24 Sep 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Jul 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CC-4047-MMM-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00463385
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Celgene Corporation
    Sponsor organisation address
    86 Morris Avenue, Summit, NJ, United States, 07901
    Public contact
    Clinical Trial Disclosure 86 Morris Avenue Summit, NJ 07901, Celgene Corporation 86 Morris Avenue Summit, NJ 07901, 1 866-260-1599, ClinicalTrialDisclosure@Celgene.com
    Scientific contact
    Robert Gale, MD 86 Morris Avenue Summit, NJ 07901, Robert Gale, MD Celgene Corporation 86 Morris Avenue Summit, NJ 07901, RGale@Celgene.com
    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
    13 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To select a treatment regimen of CC-4047 either as single-agent or in combination with prednisone to study further in subjects with myelofibrosis with myeloid metaplasia (MMM).
    Protection of trial subjects
    Protection of Subjects by Institutional Review Board/Independent Ethics Committee Review and Approval; Protection of Patient Confidentiality
    Background therapy
    -
    Evidence for comparator
    This study in MMM was designed to determine the appropriate CC-4047 dose and regimen as a monotherapy or in combination with prednisone. The comparator (prednisone monotherapy) facilitates the description of the Adverse Event (AE) profile of CC-4047. The prednisone control arm also allowed for a comparison in response rates of the CC-4047 mono- and combination therapies; thus providing a reasonable basis of information for designing further studies should the outcomes be in favor of a CC-4047 arm.
    Actual start date of recruitment
    19 Apr 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    United States: 52
    Worldwide total number of subjects
    88
    EEA total number of subjects
    36
    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)
    35
    From 65 to 84 years
    52
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants were entered into the Pre-randomization phase and were evaluated for the inclusion and exclusion criteria for the Double-Blind Treatment Phase of the study. The Pre-Randomization Phase did not last more than 28 days. However, the bone marrow histology for diagnosis may have preceded this period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    A double-blind technique was used and was chosen to minimize bias on the part of participants, investigators, and the sponsor. Identical placebo capsules were supplied to match the 0.5 mg and 1.0 mg pomalidomide capsules. Placebo to match prednisone was also provided. The blind was not to be broken during the Double-Blind Treatment Phase unless in the opinion of the investigator it was absolutely needed to safely treat the subject. The medical monitor was to be contacted prior to unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Prednisone
    Arm description
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study.
    Arm type
    Active comparator

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    H02 AB07
    Other name
    Deltasone; Orasone
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study.

    Investigational medicinal product name
    Pomalidomide Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study.

    Arm title
    Pomalidomide 2 mg
    Arm description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    CC-4047
    Other name
    Imnovid; Pomalyst
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal

    Investigational medicinal product name
    Prednisone Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Arm title
    Pomalidomide 2 mg + Prednisone
    Arm description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    CC-4047
    Other name
    Imnovid; Pomalyst
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. Period Title: Overall Study

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    H02 AB07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal

    Arm title
    Pomalidomide 0.5 mg + Prednisone
    Arm description
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    CC-4047
    Other name
    Imnovid
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. Period Title: Overall Study

    Investigational medicinal product name
    Predisone
    Investigational medicinal product code
    H02 AB07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Number of subjects in period 1
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Started
    22
    22
    22
    22
    Treated
    22
    22
    19
    22
    Completed
    0
    0
    0
    0
    Not completed
    22
    22
    22
    22
         Disease Progression
             6
             6
             7
             9
         Death
             2
             1
             2
             -
         Missing
             2
             -
             -
             2
         1 participant received commercial drug
             -
             1
             -
             -
         Adverse event, non-fatal
             5
             8
             4
             2
         Consent withdrawn by subject
             3
             3
             3
             4
         Unspecified
             4
             3
             6
             4
         Lost to follow-up
             -
             -
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prednisone
    Reporting group description
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study.

    Reporting group title
    Pomalidomide 2 mg
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group title
    Pomalidomide 2 mg + Prednisone
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group title
    Pomalidomide 0.5 mg + Prednisone
    Reporting group description
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone Total
    Number of subjects
    22 22 22 22 88
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    10 8 8 9 35
        From 65-84 years
    12 14 14 12 52
        85 years and over
    0 0 0 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    66 (44 to 80) 68 (50 to 83) 67.5 (36 to 82) 69.5 (43 to 86) -
    Gender categorical
    Units: Subjects
        Female
    8 5 7 9 29
        Male
    14 17 15 13 59
    Race/Ethnicity
    Units: Subjects
        White
    21 22 21 22 86
        Black
    0 0 1 0 1
        Hispanic
    1 0 0 0 1
    Janus kinase 2 (JAK2) Mutation
    JAK2^V617F mutation result based on quantitative polymerase chain reaction (PCR) analysis in neutrophil preparation.
    Units: Subjects
        Negative
    6 7 8 8 29
        Positive
    13 11 10 9 43
        Missing
    3 4 4 5 16
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG performance status scale and criteria used to assess disease progression, how the disease affects the daily living abilities of the patient, and determine appropriate treatment: 0= Fully active, able to carry on all pre-disease activities; 1= Restricted in physically strenuous activity; ambulatory and able to carry out light work; 2= Ambulatory and capable of all selfcare; unable to perform work activities. Up and about > 50% of waking hours; 3= Capable of only limited selfcare, confined to bed/chair > 50% of waking hours; 4= Completely disabled. Confined to bed or chair; 5= Dead
    Units: Subjects
        Grade 0
    12 11 6 14 43
        Grade 1
    8 9 10 6 33
        Garde 2
    2 2 5 2 11
        Missing
    0 0 1 0 1
    Myelofibrosis with myeloid metaplasia Subtype
    Units: Subjects
        Agnogenic Myeloid Metaplasia (AMM)
    16 16 16 13 61
        Postpolycythemic Myeloid Metaplasia (PPMM)
    3 4 4 2 13
        Postthromocythemic Myeloid Metaplasia (PTMM)
    3 2 2 7 14
    Red Blood Cell (RBC) Transfusion Dependence [1]
    A patient who receives at least a total of two units of RBC transfusion within 28 days on or prior to the first study drug dosing date is an RBC-transfusion-dependent patient. Otherwise a patient is an RBC-transfusion-independent patient.
    Units: Subjects
        Yes
    12 10 9 12 43
        No
    10 12 13 10 45
    Time Since Myelofibrosis Diagnosis
    Units: Years
        median (full range (min-max))
    1.5 (0 to 14.3) 0.6 (0 to 6.3) 1.1 (0 to 13) 1.7 (0 to 10.9) -
    RBC Transfusion Burden
    Units: units/28 days
        median (full range (min-max))
    2 (0 to 7) 1 (0 to 6) 0 (0 to 6) 1 (0 to 7) -

    End points

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    End points reporting groups
    Reporting group title
    Prednisone
    Reporting group description
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study.

    Reporting group title
    Pomalidomide 2 mg
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group title
    Pomalidomide 2 mg + Prednisone
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group title
    Pomalidomide 0.5 mg + Prednisone
    Reporting group description
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Primary: Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment

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    End point title
    Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment
    End point description
    A clinical responder was defined as either: a. A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or b. A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or c. A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable. Participants who discontinued the study early without achieving clinical response were counted as non-responders. Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days.
    End point type
    Primary
    End point timeframe
    Up to 168 days
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    20
    17
    19
    21
    Units: percentage of participants
        number (confidence interval 95%)
    55 (31.53 to 76.94)
    23.5 (6.81 to 49.9)
    21.1 (6.05 to 45.57)
    47.6 (25.71 to 70.22)
    Statistical analysis title
    Clinical Response
    Statistical analysis description
    Statistical Analysis 1 for Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment
    Comparison groups
    Prednisone v Pomalidomide 2 mg
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.092
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Clinical Response
    Statistical analysis description
    Participants With a Clinical Response Within the First 6 Cycles of Treatment
    Comparison groups
    Prednisone v Pomalidomide 2 mg + Prednisone
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.048
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Clinical Response
    Statistical analysis description
    Participants With a Clinical Response Within the First 6 Cycles of Treatment
    Comparison groups
    Prednisone v Pomalidomide 0.5 mg + Prednisone
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.758
    Method
    Fisher exact
    Confidence interval

    Secondary: Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment

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    End point title
    Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment
    End point description
    A clinical responder was defined as either: a. A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or b. A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or c. A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable. Participants who discontinued the study early without achieving clinical response were counted as non-responders. Intent-to-treat (ITT), defined as all patients who were randomized, independent of whether they received study treatment or not.
    End point type
    Secondary
    End point timeframe
    Up to 336 days
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    22
    22
    22
    22
    Units: Percentage of participants
        number (confidence interval 95%)
    50 (28.22 to 71.78)
    18.2 (5.19 to 40.28)
    18.2 (5.19 to 40.28)
    45.5 (24.39 to 67.79)
    No statistical analyses for this end point

    Secondary: Time to the First Clinical Response

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    End point title
    Time to the First Clinical Response
    End point description
    Title: Time to the First Clinical Response Description: The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as: Start date of the first clinical response - the first study drug date +1. A clinical responder was defined as either: a. A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or b. A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or c. A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable. Intent-to-treat population with a clinical response
    End point type
    Secondary
    End point timeframe
    Up to 168 days
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    11
    4
    4
    10
    Units: weeks
        median (full range (min-max))
    0.3 (0.1 to 15.6)
    8 (2.6 to 17.3)
    10.1 (0.1 to 20)
    1.2 (0.1 to 16.6)
    No statistical analyses for this end point

    Secondary: Duration of First Clinical Response

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    End point title
    Duration of First Clinical Response
    End point description
    For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administered at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment. For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement. Kaplan-Meier methodology was used.
    End point type
    Secondary
    End point timeframe
    Up to 40 months
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    11
    4 [1]
    4
    10
    Units: months
        median (confidence interval 95%)
    3.7 (3 to 6.6)
    9999 (4.7 to 9999)
    6 (2.3 to 9.8)
    10.6 (2.8 to 16.1)
    Notes
    [1] - Median not estimable as only 1 patient progressed in this group as defined by 9999
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores

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    End point title
    Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores
    End point description
    The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. • Physical Well-being consists of 7 questions, the subscale score ranges from 0-28; • Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28; • Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24; • Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28; • Anemia subscale consists of 20 questions, the subscale score ranges from 0-80; • Total FACT-An score ranges from 0-188. Intent-to-treat patients with available data.
    End point type
    Secondary
    End point timeframe
    Baseline and Cycle 6 (168 days).
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    9
    7
    3
    12
    Units: units on a scale
    arithmetic mean (standard deviation)
        Physical Well-Being subscale
    0.6 ± 1.5
    0.4 ± 6.42
    5.3 ± 4.04
    2.3 ± 2.26
        Social/Family Well-Being subscale
    1.9 ± 3.08
    -1.9 ± 2.59
    1.7 ± 3.79
    0.9 ± 6.84
        Emotional Well-Being subscale
    1.3 ± 3.32
    0 ± 4.76
    -0.3 ± 2.7
    1.7 ± 3.47
        Functional Well-Being subscale
    0.9 ± 4.14
    -2.1 ± 8.99
    2.7 ± 3.06
    2.5 ± 6.5
        Anemia subscale
    1.2 ± 9.47
    2.3 ± 21.34
    19.3 ± 18.93
    5.8 ± 8.85
        total Fact-Anemia Score
    2.3 ± 12.42
    1.6 ± 36.51
    27.3 ± 25.74
    11.4 ± 13.51
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hemoglobin Concentration for Responders

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    End point title
    Change From Baseline in Hemoglobin Concentration for Responders
    End point description
    Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment. Intent-to-treat participants with a clinical response and available hemoglobin values at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 6 (168 days)
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    6
    2
    0 [2]
    8
    Units: g/dL
        median (full range (min-max))
    1.4 (-0.5 to 4.1)
    2 (0.7 to 3.2)
    ( to )
    -0.1 (-1.9 to 3.9)
    Notes
    [2] - No participants with a hemoglobin response in this group
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hemoglobin Concentration for Non-Responders

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    End point title
    Change From Baseline in Hemoglobin Concentration for Non-Responders
    End point description
    Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment. Intent-to-treat participants with no clinical response and available hemoglobin values at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 6 (168 days)
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    3
    5
    5
    6
    Units: g/dL
        median (full range (min-max))
    1.2 (-0.2 to 2.7)
    0.1 (-0.8 to 1.3)
    -0.8 (-2 to 1.9)
    0.5 (-0.3 to 1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Likert Abdominal Pain Scale

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    End point title
    Change From Baseline in Likert Abdominal Pain Scale
    End point description
    Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable. Intent-to-treat patients with available data.
    End point type
    Secondary
    End point timeframe
    Baseline and Cycle 6 (168 days)
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    10
    7
    3
    12
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.3 ± 1.83
    -1 ± 3.11
    0.3 ± 1.15
    -0.1 ± 1.68
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events (AEs)

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    End point title
    Number of Participants With Adverse Events (AEs)
    End point description
    A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above). The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death. The Investigator determined the relationship between study drug and the occurrence of an AE as "Not Related" or "Related" (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa). Safety population (all treated patients).
    End point type
    Secondary
    End point timeframe
    From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    22
    22
    19
    22
    Units: Participants
    number (not applicable)
        At least one AE
    20
    21
    18
    21
        At least one AE related to pomalidomide
    15
    17
    16
    15
        At least one AE related to prednisone
    10
    10
    11
    5
        At least one Grade 3-4 AE
    10
    14
    13
    15
        At least one Grade 3-4 AE related to pomalidomide
    6
    7
    11
    6
        At least one Grade 3-4 AE related to prednisone
    5
    2
    6
    3
        At least one SAE
    6
    10
    11
    8
        At least one SAE related to pomalidomide
    4
    6
    8
    3
        At least one SAE related to prednisone
    4
    3
    5
    3
        AE leading to discontinuation of pomalidomide
    7
    11
    5
    6
        AE leading to discontinuation of prednisone
    5
    7
    2
    1
        AE leading to a dose reduction of pomalidomide
    0
    2
    1
    1
        AE leading to a dose interruption of pomalidomide
    5
    9
    9
    7
        AE leading to a dose interruption of prednisone
    2
    8
    6
    3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Response by Baseline JAK2 Positive Assessment

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    End point title
    Percentage of Participants With Clinical Response by Baseline JAK2 Positive Assessment
    End point description
    Percentage of participants who achieved a clinical response, presented by participants with positive janus kinase 2 (JAK2) V617F mutation results at Baseline. Includes Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive JAK2 result for each treatment group respectively.
    End point type
    Secondary
    End point timeframe
    Up to 336 days
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    13 [3]
    11 [4]
    10 [5]
    9 [6]
    Units: Percentage of participants
        number (not applicable)
    46.2
    27.3
    30
    66.7
    Notes
    [3] - Includes those who were positive for the janus kinase 2 (JAK2) V617F results.
    [4] - Includes those who were positive for the janus kinase 2 (JAK2) V617F results.
    [5] - Includes those who were positive for the janus kinase 2 (JAK2) V617F results.
    [6] - Includes those who were positive for the janus kinase 2 (JAK2) V617F results.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Response by Baseline JAK2 Negative Assessment

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    End point title
    Percentage of Participants With Clinical Response by Baseline JAK2 Negative Assessment
    End point description
    Percentage of participants who achieved a clinical response, presented by participants with negative janus kinase 2 (JAK2) V617F mutation results at Baseline. Includes Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a negative JAK2 result for each treatment group respectively.
    End point type
    Secondary
    End point timeframe
    Up to 336 days
    End point values
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Number of subjects analysed
    6 [7]
    7 [8]
    8 [9]
    8 [10]
    Units: Percentage of participants who achieved
        number (not applicable)
    50
    28.6
    12.5
    25
    Notes
    [7] - Includes those who were negative for the janus kinase 2 (JAK2) V617F results.
    [8] - Includes those who were negative for the janus kinase 2 (JAK2) V617F results.
    [9] - Includes those who were negative for the janus kinase 2 (JAK2) V617F results.
    [10] - Includes those who were negative for the janus kinase 2 (JAK2) V617F results.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of the study drug through to 30 days after the last dose; up to the data cut-off date of 18 December 2013; up to 81 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Prednisone
    Reporting group description
    Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study

    Reporting group title
    Pomalidomide 2 mg
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. Period Title: Overall Study

    Reporting group title
    Pomalidomide 2 mg + Prednisone
    Reporting group description
    Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone capsules on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Reporting group title
    Pomalidomide 0.5 mg + Prednisone
    Reporting group description
    Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.

    Serious adverse events
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 22 (27.27%)
    10 / 22 (45.45%)
    11 / 19 (57.89%)
    8 / 22 (36.36%)
         number of deaths (all causes)
    2
    3
    4
    1
         number of deaths resulting from adverse events
    2
    3
    3
    0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease Progression
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental Status Changes
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Investigations
    International Normalised Ratio Increased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Acute
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Acquired Von Willebrand Disease
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Memory Impairment
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Failure Chronic
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lung infection pseudomonal
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 22 (13.64%)
    3 / 19 (15.79%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 5
    1 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Prednisone Pomalidomide 2 mg Pomalidomide 2 mg + Prednisone Pomalidomide 0.5 mg + Prednisone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 22 (90.91%)
    20 / 22 (90.91%)
    17 / 19 (89.47%)
    21 / 22 (95.45%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    3
    Hypertension
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    4 / 22 (18.18%)
         occurrences all number
    1
    4
    1
    7
    Chills
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    4 / 22 (18.18%)
         occurrences all number
    4
    2
    2
    5
    Fatigue
         subjects affected / exposed
    6 / 22 (27.27%)
    2 / 22 (9.09%)
    6 / 19 (31.58%)
    7 / 22 (31.82%)
         occurrences all number
    17
    3
    12
    27
    Feeling jittery
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gait Disturbance
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    8
    0
    0
    Oedema
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    0
    2
    Oedema peripheral
         subjects affected / exposed
    6 / 22 (27.27%)
    8 / 22 (36.36%)
    10 / 19 (52.63%)
    10 / 22 (45.45%)
         occurrences all number
    7
    8
    24
    20
    Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    0
    3
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Depression
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Insomnia
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    3 / 22 (13.64%)
         occurrences all number
    6
    2
    2
    5
    Mental Status Changes
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Personality Change
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    2
    1
    Excoriation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Cardiac Murmur
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    0
    2
    Heart Rate Increased
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    3
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sinus Bradycardia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 22 (27.27%)
    6 / 22 (27.27%)
    4 / 19 (21.05%)
    8 / 22 (36.36%)
         occurrences all number
    6
    6
    4
    12
    Dysphonia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    4
    2
    Dyspnoea
         subjects affected / exposed
    7 / 22 (31.82%)
    7 / 22 (31.82%)
    3 / 19 (15.79%)
    6 / 22 (27.27%)
         occurrences all number
    7
    9
    6
    24
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    5 / 19 (26.32%)
    3 / 22 (13.64%)
         occurrences all number
    1
    2
    6
    5
    Nasal Congestion
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    1
    4
    Pleural Effusion
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Pleuritic Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary Hypertension
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 22 (22.73%)
    3 / 19 (15.79%)
    5 / 22 (22.73%)
         occurrences all number
    2
    7
    4
    12
    Leukopenia
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 22 (13.64%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    4
    0
    5
    Neutropenia
         subjects affected / exposed
    1 / 22 (4.55%)
    5 / 22 (22.73%)
    3 / 19 (15.79%)
    3 / 22 (13.64%)
         occurrences all number
    1
    21
    13
    6
    Thrombocytopenia
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 22 (22.73%)
    3 / 19 (15.79%)
    3 / 22 (13.64%)
         occurrences all number
    2
    10
    9
    3
    Thrombocytosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    2
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Balance Disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Burning Sensation
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    3
    0
    0
    2
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
    6 / 19 (31.58%)
    8 / 22 (36.36%)
         occurrences all number
    4
    2
    11
    37
    Dysgeusia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    2
    2
    0
    5
    Hypoaesthesia
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    2
    12
    Memory Impairment
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Migraine
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
    3 / 19 (15.79%)
    4 / 22 (18.18%)
         occurrences all number
    5
    2
    4
    15
    Tremor
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Eye disorders
    Eye Irritation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    2
    10
    Lacrimation Increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Periorbital Oedema
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    10
    Vision blurred
         subjects affected / exposed
    3 / 22 (13.64%)
    2 / 22 (9.09%)
    4 / 19 (21.05%)
    1 / 22 (4.55%)
         occurrences all number
    3
    6
    4
    1
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    1
    0
    3
    Abdominal Pain
         subjects affected / exposed
    4 / 22 (18.18%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    5 / 22 (22.73%)
         occurrences all number
    5
    4
    2
    12
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    3 / 22 (13.64%)
         occurrences all number
    2
    2
    1
    3
    Ascites
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Constipation
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    5 / 19 (26.32%)
    4 / 22 (18.18%)
         occurrences all number
    2
    6
    6
    19
    Diarrhoea
         subjects affected / exposed
    6 / 22 (27.27%)
    6 / 22 (27.27%)
    8 / 19 (42.11%)
    1 / 22 (4.55%)
         occurrences all number
    7
    10
    13
    6
    Dyspepsia
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    5 / 19 (26.32%)
    3 / 22 (13.64%)
         occurrences all number
    0
    2
    5
    6
    Flatulence
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    2
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    2
    2
    Nausea
         subjects affected / exposed
    4 / 22 (18.18%)
    4 / 22 (18.18%)
    3 / 19 (15.79%)
    1 / 22 (4.55%)
         occurrences all number
    5
    5
    7
    1
    Oral pain
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    0
    1
    Tongue ulceration
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 22 (9.09%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    3 / 22 (13.64%)
         occurrences all number
    2
    3
    1
    8
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Urinary Incontinence
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ecchymosis
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    1
    3
    1
    1
    Erythema
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    2
    0
    5
    Increased Tendency To Bruise
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Night Sweats
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    5 / 22 (22.73%)
         occurrences all number
    3
    2
    1
    8
    Pruritus
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    3 / 22 (13.64%)
         occurrences all number
    1
    2
    2
    6
    Rash
         subjects affected / exposed
    1 / 22 (4.55%)
    8 / 22 (36.36%)
    3 / 19 (15.79%)
    3 / 22 (13.64%)
         occurrences all number
    1
    14
    3
    6
    Rash Pruritic
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin Odour Abnormal
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 22 (13.64%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    2 / 22 (9.09%)
         occurrences all number
    5
    3
    1
    5
    Back Pain
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    1 / 22 (4.55%)
         occurrences all number
    1
    3
    2
    1
    Bone Pain
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 22 (13.64%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Muscle Spasms
         subjects affected / exposed
    3 / 22 (13.64%)
    1 / 22 (4.55%)
    6 / 19 (31.58%)
    5 / 22 (22.73%)
         occurrences all number
    4
    1
    6
    6
    Muscular Weakness
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    1
    0
    4
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Myalgia
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    4 / 22 (18.18%)
         occurrences all number
    7
    7
    1
    24
    Osteoarthritis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain In Extremity
         subjects affected / exposed
    2 / 22 (9.09%)
    4 / 22 (18.18%)
    2 / 19 (10.53%)
    3 / 22 (13.64%)
         occurrences all number
    2
    5
    3
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 22 (13.64%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    0
    4
    Gout
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    1
    3
    Hypokalaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    2
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    Enterococcal Sepsis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    0
    0
    7
    Pneumonia
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 22 (13.64%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    2 / 22 (9.09%)
         occurrences all number
    3
    3
    1
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2008
    For the European Union only and the following included: 1. The inclusion of new study personnel and central lab 2. The pomalidomide warning label and handling instructions 4. Allowing for additional visits, and minor administrative wording changes
    13 Aug 2008
    The protocol was amended (for all countries) to add the extension phase and for miscellaneous minor changes
    13 Feb 2009
    The protocol was amended (for all countries) to update information on: 1. An update to the study drug packaging and storage 2. A revision to the extension phase from 12 cycles to open-ended for responders 3. Minor grammatical revisions.

    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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