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    Clinical Trial Results:
    A Phase III Study of Lenalidomide and Low-Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment Naïve Multiple Myeloma (KEYNOTE 185).

    Summary
    EudraCT number
    		 2015-002901-12
    Trial protocol
    		 DE   ES   IE   FR   IT  
    Global end of trial date
    07 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2021
    First version publication date
    15 Jul 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-3475-185
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02579863
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US National Clinical Trial (NCT) unique identifier: NCT02579863, Study Name: KEYNOTE 185
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    07 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to compare the progression-free survival (PFS) as assessed by Clinical Adjudication Committee (CAC) blinded central review according to the International Myeloma Working Group response criteria (IMWG criteria) between treatment arms.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2015
    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
    Australia: 22
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Japan: 52
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    Norway: 17
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 95
    Worldwide total number of subjects
    310
    EEA total number of subjects
    71
    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)
    6
    From 65 to 84 years
    288
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 140 centers in 15 countries. The database cutoff date was August 3, 2020. Note: Due to administrative reasons (a noncompliant site), 2 participants in the Pembrolizumab plus SOC arm and one participant in the SOC arm, were recorded as "Ongoing in Trial" in the CSR Disposition Table and "Final Disposition Unknown" here.

    Pre-assignment
    Screening details
    		 1. Had a confirmed diagnosis of active multiple myeloma and measurable disease as defined in the protocol. 2. Was ineligible to receive treatment with autologous stem cell transplant (auto-SCT) due to age (≥65 years old) or any significant coexisting medical condition. Subjects <65 years old who refused auto-SCT were not eligible for this study.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pembrolizumab + Lenalidomide + Dexamethasone
    Arm description
    		 Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    MK-3475
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles

    Arm title
    		 Standard of Care (SOC) Lenolidomide + Dexamethasone
    Arm description
    		 Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles

    Number of subjects in period 1
    		Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Started
    156
    154
    Treated
    154
    148
    Completed
    0
    0
    Not completed
    156
    154
         Adverse event, serious fatal
    31
    29
         Physician decision
    1
    2
         Consent withdrawn by subject
    20
    20
         Screen Failure
    -
    2
         Adverse event, non-fatal
    18
    11
         Final Disposition Unknown
    2
    1
         Lost to follow-up
    2
    1
         Study Terminated at Selected Sites
    82
    88

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pembrolizumab + Lenalidomide + Dexamethasone
    Reporting group description
    		 Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Reporting group title
    Standard of Care (SOC) Lenolidomide + Dexamethasone
    Reporting group description
    		 Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Reporting group values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone Total
    Number of subjects
    		 156 154 310
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 1 6
        From 65-84 years
    		 144 144 288
        85 years and over
    		 7 9 16
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 74.4 ± 6.0 74.3 ± 5.9 -
    Sex: Female, Male
    Units: Participants
        Female
    		 85 81 166
        Male
    		 71 73 144
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 27 27 54
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 9 3 12
        White
    		 115 121 236
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 3 3 6
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 4 8
        Not Hispanic or Latino
    		 143 136 279
        Unknown or Not Reported
    		 9 14 23
    International Stage (I, II, III).
    The International Staging System (ISS) defines the factors that influence patient survival. The system has 3 stages based on the measurement of serum albumin and the levels of serum β2-microglobulin (β2-M). Stage I: β2-M <3.5 mg/L with a serum albumin of 3.5 g/dL or more; Stage II: Either of these 2 criteria: β2-M between 3.5 mg/L and 5.5 mg/dL Albumin <3.5 g/dL; Stage III: β2-M >5.5 mg/L.
    Units: Subjects
        Stage I
    		 39 53 92
        Stage II
    		 70 66 136
        Stage III
    		 46 34 80
        Missing
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Pembrolizumab + Lenalidomide + Dexamethasone
    Reporting group description
    		 Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Reporting group title
    Standard of Care (SOC) Lenolidomide + Dexamethasone
    Reporting group description
    		 Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Primary: Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) Response Criteria 2011 by Clinical Adjudication Committee (CAC) Blinded Central Review

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    End point title
    		 Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) Response Criteria 2011 by Clinical Adjudication Committee (CAC) Blinded Central Review
    End point description
    PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. A relatively small number of events resulted in high variabilities and the inability to estimate certain parameters (i.e. medians and confidence limits). A value of "9999" indicates that at the time of data cut-off parameters could not be estimated. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Primary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    156
    154
    Units: Months
        median (confidence interval 95%)
    19.6 (15.3 to 9999)
    9999 (15.5 to 9999)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    Based on Cox regression model with treatment as a covariate stratified by “Age” (<75 years vs >= 75 years) and “ISS stage” (I or II vs. III).
    Comparison groups
    Pembrolizumab + Lenalidomide + Dexamethasone v Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33475 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.45
    Notes
    [1] - One-sided p-value based on Stratified log-rank test.

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from randomization to death due to any cause. OS was calculated from the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. This is an event-driven (events of death) outcome measure. "9999" indicates that at the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was August 3, 2020.
    End point type
    Secondary
    End point timeframe
    Up to approximately 55 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    156
    154
    Units: Months
        median (confidence interval 95%)
    9999 (44.6 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    Based on Cox regression model with treatment as a covariate stratified by “Age” (<75 years vs >= 75 years) and “ISS stage” (I or II vs. III).
    Comparison groups
    Pembrolizumab + Lenalidomide + Dexamethasone v Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.83416
    Method
    		 Stratified log-rank test
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.84

    Secondary: Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review

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    End point title
    		 Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
    End point description
    ORR was based on participants who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The analysis population included all randomized participants who were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    156
    154
    Units: Percentage of participants
        number (confidence interval 95%)
    74.4 (66.8 to 81.0)
    68.8 (60.9 to 76.0)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    Based on Miettinen & Nurminen method stratified by 'Age' (<75 years vs >= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.
    Comparison groups
    Pembrolizumab + Lenalidomide + Dexamethasone v Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.13102
    Method
    		 One-sided p-value for testing
    Parameter type
    		 Difference in % vs SOC
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 15.8

    Secondary: Duration of Response (DOR) Evaluated According to IMWG Response Criteria by CAC Blinded Central Review

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    End point title
    		 Duration of Response (DOR) Evaluated According to IMWG Response Criteria by CAC Blinded Central Review
    End point description
    Response duration was defined as the time from first documented evidence of at least a partial response (sCR+CR+VGPR+PR]), until confirmed disease progression or death. DOR was calculated from product-limit (Kaplan-Meier) method for censored data. This is an event-driven (events of disease progression and death) outcome measure. "9999" indicates that at the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). Full Range is the minimum and maximum of the observed duration of response. The analysis population included all randomized participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    116
    106
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC blinded central review

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    End point title
    		 Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC blinded central review
    End point description
    Disease control rate was based on participants who achieved confirmed sCR, CR, VGPR, PR, or have demonstrated SD for at least 12 weeks prior to any evidence of progression. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours; SD = not meeting the criteria for CR, VGPR, PR, or PD; PD = development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. The analysis population included all randomized participants who included in the treatment group to which they were randomized. Data cutoff date was July 9, 2018.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    156
    154
    Units: Percentage of participants
        number (confidence interval 95%)
    89.1 (83.1 to 93.5)
    91.6 (86.0 to 95.4)
    No statistical analyses for this end point

    Secondary: Second Progression Free Survival (PFS2)

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    End point title
    		 Second Progression Free Survival (PFS2)
    End point description
    PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. PFS was assessed by Clinical Adjudication Committee (CAC) blinded central review according to the IMWG response criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. PFS2 was not completed due to incomplete enrollment for a clinical hold and study cancellation.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - PFS2 was not completed due to incomplete enrollment for a clinical hold and study cancellation.
    [3] - PFS2 was not completed due to incomplete enrollment for a clinical hold and study cancellation.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced One or More Adverse Events (AEs)

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    End point title
    		 Number of Participants Who Experienced One or More Adverse Events (AEs)
    End point description
    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The analysis population consisted of all randomized participants who received at least one dose of study treatment. The database cutoff date was August 3, 2020.
    End point type
    Secondary
    End point timeframe
    Up to approximately 55 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    154
    148
    Units: Participants
    152
    141
    No statistical analyses for this end point

    Secondary: Number of Participants Discontinuing Study Treatment Due to an AE

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    End point title
    		 Number of Participants Discontinuing Study Treatment Due to an AE
    End point description
    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The analysis population consisted of all randomized participants who received at least one dose of study treatment. The database cutoff date was August 3, 2020.
    End point type
    Secondary
    End point timeframe
    Up to approximately 55 months
    End point values
    		 Pembrolizumab + Lenalidomide + Dexamethasone Standard of Care (SOC) Lenolidomide + Dexamethasone
    Number of subjects analysed
    154
    148
    Units: Participants
    44
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 55 months
    Adverse event reporting additional description
    The All-Cause Mortality analysis used all randomized participants whereas adverse events were collected for all treated participants. Disease progression of cancer under study was not considered an adverse event (AE) unless related to study treatment. The Database Cutoff Date was Aug. 3, 2020.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Pembrolizumab + Lenalidomide + Dexamethasone
    Reporting group description
    		 Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Reporting group title
    Lenolidomide + Dexamethasone
    Reporting group description
    		 Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

    Serious adverse events
    		 Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    91 / 154 (59.09%)
    65 / 148 (43.92%)
         number of deaths (all causes)
    51
    43
         number of deaths resulting from adverse events
    7
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 154 (0.65%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 154 (0.65%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypothermia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (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
    8 / 154 (5.19%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 154 (0.65%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    2 / 154 (1.30%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 154 (1.95%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 154 (5.19%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    4 / 8
    0 / 0
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 154 (0.00%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    3 / 154 (1.95%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 154 (0.00%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 154 (0.65%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 154 (0.00%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial rupture
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Fanconi syndrome
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angina pectoris
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 154 (2.60%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 154 (1.30%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 154 (0.00%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Myocarditis
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 154 (1.95%)
    5 / 148 (3.38%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytopenia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 154 (1.95%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    5 / 154 (3.25%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    5 / 154 (3.25%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic enteritis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Vomiting
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative generalised
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (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
    6 / 154 (3.90%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    4 / 154 (2.60%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 154 (0.65%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 154 (1.95%)
    3 / 148 (2.03%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torticollis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess jaw
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 154 (1.30%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 154 (1.95%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 154 (1.95%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    16 / 154 (10.39%)
    10 / 148 (6.76%)
         occurrences causally related to treatment / all
    9 / 19
    1 / 10
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 154 (1.30%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    8 / 154 (5.19%)
    4 / 148 (2.70%)
         occurrences causally related to treatment / all
    3 / 8
    0 / 4
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Septic shock
         subjects affected / exposed
    2 / 154 (1.30%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (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
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 154 (1.30%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 154 (1.30%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fulminant type 1 diabetes mellitus
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    2 / 154 (1.30%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 154 (0.65%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    143 / 154 (92.86%)
    129 / 148 (87.16%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    12 / 154 (7.79%)
    8 / 148 (5.41%)
         occurrences all number
    13
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 154 (7.14%)
    17 / 148 (11.49%)
         occurrences all number
    11
    20
    Fatigue
         subjects affected / exposed
    44 / 154 (28.57%)
    37 / 148 (25.00%)
         occurrences all number
    52
    39
    Oedema
         subjects affected / exposed
    8 / 154 (5.19%)
    6 / 148 (4.05%)
         occurrences all number
    8
    7
    Oedema peripheral
         subjects affected / exposed
    25 / 154 (16.23%)
    27 / 148 (18.24%)
         occurrences all number
    31
    28
    Pyrexia
         subjects affected / exposed
    29 / 154 (18.83%)
    10 / 148 (6.76%)
         occurrences all number
    41
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    20 / 154 (12.99%)
    18 / 148 (12.16%)
         occurrences all number
    21
    19
    Dysphonia
         subjects affected / exposed
    3 / 154 (1.95%)
    10 / 148 (6.76%)
         occurrences all number
    6
    10
    Dyspnoea
         subjects affected / exposed
    19 / 154 (12.34%)
    12 / 148 (8.11%)
         occurrences all number
    21
    12
    Epistaxis
         subjects affected / exposed
    8 / 154 (5.19%)
    6 / 148 (4.05%)
         occurrences all number
    8
    6
    Oropharyngeal pain
         subjects affected / exposed
    8 / 154 (5.19%)
    5 / 148 (3.38%)
         occurrences all number
    10
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    12 / 154 (7.79%)
    11 / 148 (7.43%)
         occurrences all number
    14
    12
    Depression
         subjects affected / exposed
    9 / 154 (5.84%)
    8 / 148 (5.41%)
         occurrences all number
    10
    8
    Insomnia
         subjects affected / exposed
    22 / 154 (14.29%)
    27 / 148 (18.24%)
         occurrences all number
    25
    33
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    11 / 154 (7.14%)
    3 / 148 (2.03%)
         occurrences all number
    11
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 154 (5.19%)
    1 / 148 (0.68%)
         occurrences all number
    8
    1
    Neutrophil count decreased
         subjects affected / exposed
    13 / 154 (8.44%)
    12 / 148 (8.11%)
         occurrences all number
    23
    23
    Weight decreased
         subjects affected / exposed
    10 / 154 (6.49%)
    17 / 148 (11.49%)
         occurrences all number
    10
    18
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 154 (1.30%)
    8 / 148 (5.41%)
         occurrences all number
    3
    10
    Fall
         subjects affected / exposed
    7 / 154 (4.55%)
    9 / 148 (6.08%)
         occurrences all number
    10
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    14 / 154 (9.09%)
    14 / 148 (9.46%)
         occurrences all number
    15
    15
    Dysgeusia
         subjects affected / exposed
    8 / 154 (5.19%)
    12 / 148 (8.11%)
         occurrences all number
    8
    12
    Headache
         subjects affected / exposed
    9 / 154 (5.84%)
    11 / 148 (7.43%)
         occurrences all number
    9
    14
    Neuropathy peripheral
         subjects affected / exposed
    9 / 154 (5.84%)
    12 / 148 (8.11%)
         occurrences all number
    11
    13
    Tremor
         subjects affected / exposed
    11 / 154 (7.14%)
    16 / 148 (10.81%)
         occurrences all number
    11
    16
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    32 / 154 (20.78%)
    27 / 148 (18.24%)
         occurrences all number
    48
    40
    Neutropenia
         subjects affected / exposed
    30 / 154 (19.48%)
    26 / 148 (17.57%)
         occurrences all number
    54
    51
    Thrombocytopenia
         subjects affected / exposed
    12 / 154 (7.79%)
    12 / 148 (8.11%)
         occurrences all number
    16
    19
    Eye disorders
    Vision blurred
         subjects affected / exposed
    11 / 154 (7.14%)
    3 / 148 (2.03%)
         occurrences all number
    12
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 154 (8.44%)
    13 / 148 (8.78%)
         occurrences all number
    16
    18
    Constipation
         subjects affected / exposed
    55 / 154 (35.71%)
    33 / 148 (22.30%)
         occurrences all number
    62
    35
    Diarrhoea
         subjects affected / exposed
    36 / 154 (23.38%)
    34 / 148 (22.97%)
         occurrences all number
    51
    48
    Dry mouth
         subjects affected / exposed
    12 / 154 (7.79%)
    5 / 148 (3.38%)
         occurrences all number
    13
    5
    Dyspepsia
         subjects affected / exposed
    8 / 154 (5.19%)
    2 / 148 (1.35%)
         occurrences all number
    9
    2
    Nausea
         subjects affected / exposed
    37 / 154 (24.03%)
    33 / 148 (22.30%)
         occurrences all number
    54
    38
    Stomatitis
         subjects affected / exposed
    9 / 154 (5.84%)
    6 / 148 (4.05%)
         occurrences all number
    11
    6
    Vomiting
         subjects affected / exposed
    30 / 154 (19.48%)
    9 / 148 (6.08%)
         occurrences all number
    39
    16
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    9 / 154 (5.84%)
    3 / 148 (2.03%)
         occurrences all number
    9
    3
    Night sweats
         subjects affected / exposed
    8 / 154 (5.19%)
    5 / 148 (3.38%)
         occurrences all number
    10
    5
    Pruritus
         subjects affected / exposed
    13 / 154 (8.44%)
    5 / 148 (3.38%)
         occurrences all number
    17
    5
    Rash
         subjects affected / exposed
    32 / 154 (20.78%)
    19 / 148 (12.84%)
         occurrences all number
    45
    20
    Rash maculo-papular
         subjects affected / exposed
    14 / 154 (9.09%)
    11 / 148 (7.43%)
         occurrences all number
    19
    13
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    13 / 154 (8.44%)
    1 / 148 (0.68%)
         occurrences all number
    13
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    17 / 154 (11.04%)
    9 / 148 (6.08%)
         occurrences all number
    21
    12
    Back pain
         subjects affected / exposed
    20 / 154 (12.99%)
    17 / 148 (11.49%)
         occurrences all number
    24
    21
    Muscle spasms
         subjects affected / exposed
    14 / 154 (9.09%)
    14 / 148 (9.46%)
         occurrences all number
    17
    16
    Muscular weakness
         subjects affected / exposed
    11 / 154 (7.14%)
    4 / 148 (2.70%)
         occurrences all number
    12
    5
    Musculoskeletal chest pain
         subjects affected / exposed
    11 / 154 (7.14%)
    7 / 148 (4.73%)
         occurrences all number
    11
    7
    Musculoskeletal pain
         subjects affected / exposed
    11 / 154 (7.14%)
    10 / 148 (6.76%)
         occurrences all number
    14
    11
    Pain in extremity
         subjects affected / exposed
    9 / 154 (5.84%)
    8 / 148 (5.41%)
         occurrences all number
    11
    10
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    9 / 154 (5.84%)
    4 / 148 (2.70%)
         occurrences all number
    12
    5
    Nasopharyngitis
         subjects affected / exposed
    11 / 154 (7.14%)
    11 / 148 (7.43%)
         occurrences all number
    16
    13
    Oral candidiasis
         subjects affected / exposed
    15 / 154 (9.74%)
    2 / 148 (1.35%)
         occurrences all number
    16
    2
    Pneumonia
         subjects affected / exposed
    11 / 154 (7.14%)
    2 / 148 (1.35%)
         occurrences all number
    11
    2
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 154 (10.39%)
    13 / 148 (8.78%)
         occurrences all number
    16
    17
    Urinary tract infection
         subjects affected / exposed
    15 / 154 (9.74%)
    12 / 148 (8.11%)
         occurrences all number
    16
    16
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    26 / 154 (16.88%)
    19 / 148 (12.84%)
         occurrences all number
    28
    21
    Dehydration
         subjects affected / exposed
    8 / 154 (5.19%)
    5 / 148 (3.38%)
         occurrences all number
    14
    6
    Gout
         subjects affected / exposed
    8 / 154 (5.19%)
    4 / 148 (2.70%)
         occurrences all number
    14
    5
    Hyperglycaemia
         subjects affected / exposed
    10 / 154 (6.49%)
    8 / 148 (5.41%)
         occurrences all number
    17
    12
    Hypocalcaemia
         subjects affected / exposed
    16 / 154 (10.39%)
    8 / 148 (5.41%)
         occurrences all number
    18
    9
    Hypokalaemia
         subjects affected / exposed
    26 / 154 (16.88%)
    17 / 148 (11.49%)
         occurrences all number
    31
    21
    Hypomagnesaemia
         subjects affected / exposed
    10 / 154 (6.49%)
    5 / 148 (3.38%)
         occurrences all number
    10
    6
    Hyponatraemia
         subjects affected / exposed
    9 / 154 (5.84%)
    1 / 148 (0.68%)
         occurrences all number
    10
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2016
    a. Addition of Lenalidomide Adult Pregnancy Risk Minimization Plan for Clinical Trials. b. Removed, Embryo-Fetal Toxicity Associated with Lenalidomide. This information is now included in another section.
    29 Jul 2016
    Clarified the exclusion criteria related to pneumonitis
    29 Jul 2016
    a. Added treatment discontinuation statement with defined population. b. Added treatment discontinuation statement.
    01 Feb 2017
    a. Updated to permanently discontinue for any recurrent Grade 2 pneumonitis. b. Follow-up Visits; To collect additional information regarding allogeneic stem cell transplants and complications following treatment with pembrolizumab.
    19 Apr 2018
    a. Added in the second paragraph: Samples obtained for PK may be used to conduct additional safety analysis, if needed. b. Pharmacokinetic/anti-drug antibody (PK/ADA) samples may be used to conduct additional safety analysis, if needed. c. Samples obtained for PK or ADA may be used to conduct additional safety analysis, if needed.
    09 Jul 2018
    a. Updated duration of survival follow-up to 12 months following discontinuation visit. b. Updated follow-up after stem cell transplant (SCT) to provide for completion of follow-up at the end of the trial. c. Updated criteria for end of the trial to include Sponsor decision to close. d. Updated criteria for completion of safety follow-up after discontinuation and after SCT to include end of trial. e. Updated criteria for completion of safety follow-up after discontinuation.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Oct 2017
    The FDA determined that the risks of pembrolizumab plus pomalidomide or lenalidomide outweighed any potential benefit for patients with multiple myeloma. Based on this decision, the treatment phase of KN183 and KN185 was closed effective immediately.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The MK-3475-185 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of subjects after study termination.
    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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