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    Clinical Trial Results:
    An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in relapsed and refractory Multiple Myeloma.

    Summary
    EudraCT number
    		 2014-003282-19
    Trial protocol
    		 NL   ES   DE   GR   FR   PL   IT  
    Global end of trial date
    21 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2022
    First version publication date
    21 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA204-125
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol Myers-Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol Myers-Squibb Study Director, Bristol Myers-Squibb, Clinical.Trials@bms.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
    10 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare progression free survival (PFS) between treatment arms
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 2016
    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
    Canada: 5
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Greece: 23
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    117
    EEA total number of subjects
    87
    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)
    44
    From 65 to 84 years
    73
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 117 participants were randomized, and 115 participants were treated.

    Period 1
    Period 1 title
    Pre-Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E-Pd Cohort
    Arm description
    		 Elotuzumab + Pomalidomide + Dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elotuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cycle 1 and 2: 10 mg/kg IV on Days 1, 8, 15, and 22 of each cycle (1 cycle = 28 days). Cycle 3 and beyond: 20 mg/Kg IV Day 1 of each cycle

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects ≤ 75 years old: 40 mg PO per day (days 1, 8, 15, and 22 of each cycle). Subjects > 75 years old: 20 mg PO per day (days 1, 8, 15, and 22 of each cycle). 1 cycle=28 days

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg PO daily (Days 1-21) of each cycle (1 cycle = 28 days).

    Arm title
    		 Pd Cohort
    Arm description
    		 Pomalidomide + Dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects ≤ 75 years old: 40 mg PO per day (days 1, 8, 15, and 22 of each cycle). Subjects > 75 years old: 20 mg PO per day (days 1, 8, 15, and 22 of each cycle). 1 cycle=28 days

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg PO daily (Days 1-21) of each cycle (1 cycle = 28 days).

    Number of subjects in period 1
    		E-Pd Cohort Pd Cohort
    Started
    60
    57
    Completed
    60
    55
    Not completed
    0
    2
         Participant Withdrew Consent
    -
    2
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E-Pd Cohort
    Arm description
    		 Elotuzumab + Pomalidomide + Dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elotuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cycle 1 and 2: 10 mg/kg IV on Days 1, 8, 15, and 22 of each cycle (1 cycle = 28 days). Cycle 3 and beyond: 20 mg/Kg IV Day 1 of each cycle

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects ≤ 75 years old: 40 mg PO per day (days 1, 8, 15, and 22 of each cycle). Subjects > 75 years old: 20 mg PO per day (days 1, 8, 15, and 22 of each cycle). 1 cycle=28 days

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg PO daily (Days 1-21) of each cycle (1 cycle = 28 days).

    Arm title
    		 Pd Cohort
    Arm description
    		 Pomalidomide + Dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects ≤ 75 years old: 40 mg PO per day (days 1, 8, 15, and 22 of each cycle). Subjects > 75 years old: 20 mg PO per day (days 1, 8, 15, and 22 of each cycle). 1 cycle=28 days

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg PO daily (Days 1-21) of each cycle (1 cycle = 28 days).

    Number of subjects in period 2
    		E-Pd Cohort Pd Cohort
    Started
    60
    55
    Completed
    0
    0
    Not completed
    60
    55
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    1
         Disease progression
    43
    38
         Adverse Event unrelated to study drug
    6
    9
         Study drug toxicity
    2
    2
         Participant request to discontinue
    2
    -
         Maximum Clinical Benefit
    -
    2
         Other reasons
    4
    2
         Administrative reasons by sponsor
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E-Pd Cohort
    Reporting group description
    		 Elotuzumab + Pomalidomide + Dexamethasone

    Reporting group title
    Pd Cohort
    Reporting group description
    		 Pomalidomide + Dexamethasone

    Reporting group values
    		 E-Pd Cohort Pd Cohort Total
    Number of subjects
    		 60 57 117
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 22 22 44
        >=65 years
    		 38 35 73
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.2 ± 9.92 65.5 ± 9.95 -
    Sex: Female, Male
    Units: Participants
        Female
    		 28 22 50
        Male
    		 32 35 67
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 45 45 90
        Black or African American
    		 0 1 1
        Asian
    		 15 9 24
        Other
    		 0 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 10 18 28
        Unknown or Not Reported
    		 49 39 88

    End points

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    End points reporting groups
    Reporting group title
    E-Pd Cohort
    Reporting group description
    		 Elotuzumab + Pomalidomide + Dexamethasone

    Reporting group title
    Pd Cohort
    Reporting group description
    		 Pomalidomide + Dexamethasone
    Reporting group title
    E-Pd Cohort
    Reporting group description
    		 Elotuzumab + Pomalidomide + Dexamethasone

    Reporting group title
    Pd Cohort
    Reporting group description
    		 Pomalidomide + Dexamethasone

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder. 9999=NA
    End point type
    Primary
    End point timeframe
    From randomization to date of progression or death (up to approximately 21 months)
    End point values
    		 E-Pd Cohort Pd Cohort
    Number of subjects analysed
    60
    57
    Units: Months
        median (confidence interval 95%)
    10.25 (6.54 to 9999)
    4.70 (2.83 to 7.62)
    Statistical analysis title
    		 PFS
    Comparison groups
    E-Pd Cohort v Pd Cohort
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0043
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.82

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator’s assessment - CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow - sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence - VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour - PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
    End point type
    Secondary
    End point timeframe
    From first dose to disease progression (up to approximately 21 months)
    End point values
    		 E-Pd Cohort Pd Cohort
    Number of subjects analysed
    60
    57
    Units: Percent of participants
        number (confidence interval 95%)
    58.3 (44.9 to 70.9)
    24.6 (14.1 to 37.8)
    Statistical analysis title
    		 ORR
    Comparison groups
    E-Pd Cohort v Pd Cohort
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.05
         upper limit
    		 10.43

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.
    End point type
    Secondary
    End point timeframe
    From randomization to death (up to approximately 52 months)
    End point values
    		 E-Pd Cohort Pd Cohort
    Number of subjects analysed
    60
    57
    Units: Months
        median (confidence interval 95%)
    29.80 (22.87 to 45.67)
    17.41 (13.83 to 27.70)
    Statistical analysis title
    		 OS Analysis
    Comparison groups
    E-Pd Cohort v Pd Cohort
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0217
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.93

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)
    Adverse event reporting additional description
    All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    E-Pd Cohort
    Reporting group description
    		 Elotuzumab + Pomalidomide + Dexamethasone

    Reporting group title
    Pd Cohort
    Reporting group description
    		 Pomalidomide + Dexamethasone

    Serious adverse events
    		 E-Pd Cohort Pd Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 60 (70.00%)
    33 / 55 (60.00%)
         number of deaths (all causes)
    41
    41
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 60 (1.67%)
    7 / 55 (12.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to bone
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell leukaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    General physical health deterioration
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Primary amyloidosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder prolapse
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 60 (6.67%)
    5 / 55 (9.09%)
         occurrences causally related to treatment / all
    3 / 5
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia influenzal
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    1 / 2
    Sepsis
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 E-Pd Cohort Pd Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 60 (93.33%)
    49 / 55 (89.09%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 60 (13.33%)
    5 / 55 (9.09%)
         occurrences all number
    12
    5
    Pyrexia
         subjects affected / exposed
    11 / 60 (18.33%)
    12 / 55 (21.82%)
         occurrences all number
    19
    15
    Oedema peripheral
         subjects affected / exposed
    11 / 60 (18.33%)
    5 / 55 (9.09%)
         occurrences all number
    14
    7
    Fatigue
         subjects affected / exposed
    11 / 60 (18.33%)
    8 / 55 (14.55%)
         occurrences all number
    11
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 60 (8.33%)
    5 / 55 (9.09%)
         occurrences all number
    10
    7
    Dyspnoea
         subjects affected / exposed
    9 / 60 (15.00%)
    4 / 55 (7.27%)
         occurrences all number
    9
    4
    Productive cough
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 55 (7.27%)
         occurrences all number
    4
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 55 (3.64%)
         occurrences all number
    4
    2
    Insomnia
         subjects affected / exposed
    10 / 60 (16.67%)
    7 / 55 (12.73%)
         occurrences all number
    11
    8
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 60 (6.67%)
    6 / 55 (10.91%)
         occurrences all number
    4
    6
    Neutrophil count decreased
         subjects affected / exposed
    4 / 60 (6.67%)
    5 / 55 (9.09%)
         occurrences all number
    5
    8
    White blood cell count decreased
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    Platelet count decreased
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 55 (7.27%)
         occurrences all number
    4
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 55 (5.45%)
         occurrences all number
    2
    5
    Hypoaesthesia
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 55 (1.82%)
         occurrences all number
    4
    1
    Neuropathy peripheral
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    Polyneuropathy
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 55 (1.82%)
         occurrences all number
    4
    1
    Tremor
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 55 (3.64%)
         occurrences all number
    4
    3
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    6 / 60 (10.00%)
    1 / 55 (1.82%)
         occurrences all number
    10
    1
    Anaemia
         subjects affected / exposed
    17 / 60 (28.33%)
    21 / 55 (38.18%)
         occurrences all number
    29
    30
    Leukopenia
         subjects affected / exposed
    5 / 60 (8.33%)
    4 / 55 (7.27%)
         occurrences all number
    17
    4
    Neutropenia
         subjects affected / exposed
    16 / 60 (26.67%)
    17 / 55 (30.91%)
         occurrences all number
    27
    27
    Thrombocytopenia
         subjects affected / exposed
    9 / 60 (15.00%)
    11 / 55 (20.00%)
         occurrences all number
    10
    13
    Eye disorders
    Cataract
         subjects affected / exposed
    5 / 60 (8.33%)
    0 / 55 (0.00%)
         occurrences all number
    6
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 55 (7.27%)
         occurrences all number
    1
    4
    Constipation
         subjects affected / exposed
    14 / 60 (23.33%)
    6 / 55 (10.91%)
         occurrences all number
    18
    7
    Stomatitis
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 55 (1.82%)
         occurrences all number
    4
    1
    Nausea
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 55 (9.09%)
         occurrences all number
    2
    6
    Diarrhoea
         subjects affected / exposed
    15 / 60 (25.00%)
    7 / 55 (12.73%)
         occurrences all number
    22
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 60 (10.00%)
    6 / 55 (10.91%)
         occurrences all number
    9
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 60 (6.67%)
    7 / 55 (12.73%)
         occurrences all number
    4
    7
    Back pain
         subjects affected / exposed
    6 / 60 (10.00%)
    5 / 55 (9.09%)
         occurrences all number
    7
    5
    Bone pain
         subjects affected / exposed
    11 / 60 (18.33%)
    5 / 55 (9.09%)
         occurrences all number
    15
    6
    Pain in extremity
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    Muscular weakness
         subjects affected / exposed
    2 / 60 (3.33%)
    4 / 55 (7.27%)
         occurrences all number
    2
    5
    Muscle spasms
         subjects affected / exposed
    9 / 60 (15.00%)
    4 / 55 (7.27%)
         occurrences all number
    12
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 55 (7.27%)
         occurrences all number
    5
    5
    Bronchitis
         subjects affected / exposed
    9 / 60 (15.00%)
    5 / 55 (9.09%)
         occurrences all number
    12
    6
    Respiratory tract infection
         subjects affected / exposed
    10 / 60 (16.67%)
    5 / 55 (9.09%)
         occurrences all number
    13
    7
    Pneumonia
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 55 (5.45%)
         occurrences all number
    5
    3
    Pharyngitis
         subjects affected / exposed
    5 / 60 (8.33%)
    1 / 55 (1.82%)
         occurrences all number
    5
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 60 (13.33%)
    9 / 55 (16.36%)
         occurrences all number
    11
    11
    Nasopharyngitis
         subjects affected / exposed
    15 / 60 (25.00%)
    9 / 55 (16.36%)
         occurrences all number
    22
    14
    Urinary tract infection
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 55 (5.45%)
         occurrences all number
    6
    4
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    13 / 60 (21.67%)
    11 / 55 (20.00%)
         occurrences all number
    17
    13
    Hypercalcaemia
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 55 (9.09%)
         occurrences all number
    3
    7
    Decreased appetite
         subjects affected / exposed
    6 / 60 (10.00%)
    4 / 55 (7.27%)
         occurrences all number
    6
    6
    Hypokalaemia
         subjects affected / exposed
    7 / 60 (11.67%)
    7 / 55 (12.73%)
         occurrences all number
    9
    9
    Hypomagnesaemia
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Nov 2015
    Updates to risk management programs
    12 Feb 2020
    Updates on OS statistical considerations. Updates on assessment for efficacy analyses

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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