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    Clinical Trial Results:
    Efficacy of Daratumumab in Patients with Relapsed/Refractory Myeloma with Renal Impairment

    Summary
    EudraCT number
    		 2017-003950-18
    Trial protocol
    		 GR   IT  
    Global end of trial date
    22 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2022
    First version publication date
    01 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ΕΑΕ-2017/ΜΜ02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03450057
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hellenic Society of Hematology
    Sponsor organisation address
    27 Kifisias Ave, Athens, Greece, 11523
    Public contact
    Prof. Panayiotidis Panayiotis, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, 0030 2107211806, infohaema@eae.gr
    Scientific contact
    Health Data Specialists Ireland, Health Data Specialists Ireland Limited, 0035 3906480600, info@heads-research.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
    17 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate progression free survival (PFS) in subjects with relapsed or refractory multiple myeloma (RRMM) and renal impairment (RI) treated with daratumumab and dexamethasone (DaraD).
    Protection of trial subjects
    This study was conducted in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Feb 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 13 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 34
    Country: Number of subjects enrolled
    Italy: 4
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    10
    From 65 to 84 years
    26
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 38 patients were enrolled and initiated study treatment across 5 centers in Greece and 2 centers in Italy.

    Pre-assignment
    Screening details
    		 Patients who did not meet all the inclusion criteria or met any of the exclusion criteria were considered screening failures.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 1st Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Dara, Darzalex
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daratumumab was given at a dose of 16 mg/kg and administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to standard clinical practice. The recommended dose of dexamethasone was 40 mg (20 mg for patients ˃ 75 years of age) orally once daily on Days 1, 8, 15 and 22 of each 28-day treatment cycle.

    Number of subjects in period 1
    		1st Arm
    Started
    38
    Completed
    15
    Not completed
    23
         Consent withdrawn by subject
    4
         Death
    17
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 38 38
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 26 26
        85 years and over
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.6 ( 11.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 9 9
    Race/Ethnicity, Customized
    Units: Subjects
        Greek
    		 32 32
        Other European
    		 4 4
        Other
    		 2 2
    Region of Enrollment
    Units: Subjects
        General Hospital of Athens "ALEXANDRA"
    		 26 26
        University Hospital of Patras
    		 4 4
        S. Orsola Malpighi
    		 3 3
        Evangelismos Hospital
    		 2 2
        Theagenio" Anticancer Hospital of Thesaloniki
    		 1 1
        AUSL Santa Maria Nuova - IRCCS - Ematologia
    		 1 1
        LAIKO General Hospital of Athens
    		 1 1
    Subject analysis sets

    Subject analysis set title
    Intra-group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline control group.

    Subject analysis sets values
    		 Intra-group
    Number of subjects
    38
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    10
        From 65-84 years
    26
        85 years and over
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.6 ( 11.2 )
    Gender categorical
    Units: Subjects
        Female
    29
        Male
    9
    Race/Ethnicity, Customized
    Units: Subjects
        Greek
    32
        Other European
    4
        Other
    2
    Region of Enrollment
    Units: Subjects
        General Hospital of Athens "ALEXANDRA"
    26
        University Hospital of Patras
    4
        S. Orsola Malpighi
    3
        Evangelismos Hospital
    2
        Theagenio" Anticancer Hospital of Thesaloniki
    1
        AUSL Santa Maria Nuova - IRCCS - Ematologia
    1
        LAIKO General Hospital of Athens
    1

    End points

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    End points reporting groups
    Reporting group title
    1st Arm
    Reporting group description
    		 -

    Subject analysis set title
    Intra-group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline control group.

    Primary: The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.

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    End point title
    		 The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.
    End point description
    Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
    End point type
    Primary
    End point timeframe
    Duration from first daratumumab administration until death or last assessment, months.
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38
    38 [1]
    Units: Months
        median (confidence interval 95%)
    11.8 (2.8 to 20.8)
    0 (0 to 0)
    Notes
    [1] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 20.8
    Notes
    [2] - The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    Overall response rate was defined as the proportion of subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response.
    End point type
    Secondary
    End point timeframe
    From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months)
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38
    38 [3]
    Units: percent
    number (confidence interval 95%)
        Overall Response Rate (ORR)
    47.4 (31.5 to 63.2)
    0 (0 to 0)
    Notes
    [3] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    47.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.5
         upper limit
    		 63.2

    Secondary: Renal Response Rate (RRR)

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    End point title
    		 Renal Response Rate (RRR)
    End point description
    Renal response rate was defined as the proportion of enrolled subjects who achieve a best response of renal partial response (PRRenal) or better using the IMWG criteria.
    End point type
    Secondary
    End point timeframe
    From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months).
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38
    38 [4]
    Units: percent
    number (confidence interval 95%)
        Renal Response Rate (RR)
    18.4 (7.7 to 34.3)
    0 (0 to 0)
    Notes
    [4] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.7
         upper limit
    		 34.3

    Secondary: Duration of Response in Patients With RI

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    End point title
    		 Duration of Response in Patients With RI
    End point description
    Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response were first met until the date of a progression event (according to the primary definition of PFS).
    End point type
    Secondary
    End point timeframe
    Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months).
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    18 [5]
    18 [6]
    Units: Months
    median (confidence interval 95%)
        Duration of Response in Patient with RI
    28.4 (15.1 to 100)
    0 (0 to 0)
    Notes
    [5] - Upper limit not reached; please ignore value of '100', as it is only for platform validation purpose
    [6] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    28.4
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 15.1
         upper limit
    		 -

    Secondary: Time to Next Therapy

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    End point title
    		 Time to Next Therapy
    End point description
    Time to next therapy was defined as the time, in months, from Cycle 1 Day 1 to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.
    End point type
    Secondary
    End point timeframe
    From first dose until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 30 months).
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38 [7]
    38 [8]
    Units: Months
    median (confidence interval 95%)
        Time to Next Therapy
    18.0 (5.5 to 100)
    0 (0 to 0)
    Notes
    [7] - Upper limit not reached; please ignore value of '100', as it is only for platform validation purpose
    [8] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 5.5
         upper limit
    		 -

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time, in months, from the first dose of therapy to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    Time from first dose of study treatment to death (approximately up to 30 months).
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38 [9]
    38 [10]
    Units: month
    median (confidence interval 95%)
        Overall Survival
    24.5 (5.5 to 100)
    0 (0 to 0)
    Notes
    [9] - Upper limit not reached; please ignore value of '100', as it is only for platform validation purpose
    [10] - Intra-group used for baseline statistical analysis.
    Statistical analysis title
    		 Kaplan-Meier product-limit method
    Statistical analysis description
    All statistical analyses and generation of tables and patient data listings were performed using SAS® statistical analysis software (v. 9.4). Summary statistics based on frequency tables were used for categorical variables. For continuous variables, descriptive statistics (mean, median, standard deviation, Q1, Q3, min, and max values) were used. The Kaplan-Meier method was applied for all time-to-event analyses.
    Comparison groups
    1st Arm v Intra-group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan-Meier product-limit
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 5.5
         upper limit
    		 -

    Secondary: To assess the safety and tolerability of daratumumab with dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM) and renal impairment (RI)

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    End point title
    		 To assess the safety and tolerability of daratumumab with dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM) and renal impairment (RI)
    End point description
    The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.
    End point type
    Secondary
    End point timeframe
    Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).
    End point values
    		 1st Arm Intra-group
    Number of subjects analysed
    38
    38 [11]
    Units: Participants
    number (not applicable)
        Any (N)SAE
    34
    0
        Any NSAE
    32
    0
        Any SAE
    11
    0
        Any (N)SADR related to daratumumab
    7
    0
        Any NSADR related to daratumumab
    7
    0
        Any SADR related to daratumumab
    1
    0
        Any (N)SAE of Grade >=3
    24
    0
        Any (N)SAE of Grade 3 or 4
    19
    0
        Any fatal SAE
    7
    0
    Notes
    [11] - Intra-group used for baseline statistical analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 years.
    Adverse event reporting additional description
    All patients who received at least one dose of study treatment were considered for data analysis. The incidence of adverse events (AEs) was tabulated by MedDRA System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 38 (28.95%)
         number of deaths (all causes)
    17
         number of deaths resulting from adverse events
    7
    Investigations
    Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Peritonitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 3
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 38 (84.21%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Surgical and medical procedures
    Carpal tunnel decompression
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 38 (23.68%)
         occurrences all number
    9
    Influenza like illness
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    6
    Pyrexia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Swelling
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Tension
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Neutrophil count decreased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Platelet count decreased
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    6
    Weight decreased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Atrial tachycardia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Bradycardia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 38 (28.95%)
         occurrences all number
    16
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pancytopenia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    External ear inflammation
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    5
    Gastritis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Bone pain
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Groin pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Hypercalcaemia
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Hyperglycaemia
         subjects affected / exposed
    6 / 38 (15.79%)
         occurrences all number
    9
    Hyperkalaemia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    4
    Hyperuricaemia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    12
    Hypokalaemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2018
    To clarify the below listed sections of the protocol and align it with other protocols of daratumumab studies.
    13 Jul 2018
    To update the protocol based on Italian health authority recommendations.
    09 Jul 2019
    To update the protocol based on new guidelines regarding the risk of HBV reactivation, give clarifications regarding the subject population, and provide additional recommendations on handling daratumumab delays and toxicities.
    08 Jun 2020
    To update the protocol regarding the overall duration of the study, from 30 to 37 months.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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