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    Clinical Trial Results:
    An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy(Including a Proteasome Inhibitor and Immunomodulatory drug (IMiD)) or are Double Refractory to a Proteasome Inhibitor and an IMiD

    Summary
    EudraCT number
    		 2013-000752-18
    Trial protocol
    		 BE   ES  
    Global end of trial date
    30 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2018
    First version publication date
    02 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR102651
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01985126
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development LLC, ClinicalTrialsEU@its.jnj.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
    30 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of the study was to determine the efficacy of 2 daratumumab treatment regimens, as measured by the overall response rate (ORR) (partial response [PR] or better), in subjects with multiple myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or whose disease was double refractory to both a PI and an IMiD agent.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.The safety assessments included clinical laboratory tests (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs), physical examinations and adverse events were reported throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 44 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 22
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United States: 90
    Worldwide total number of subjects
    124
    EEA total number of subjects
    12
    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)
    66
    From 65 to 84 years
    58
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 150 subjects were planned to enroll but 124 subjects were enrolled and analyzed in this study. Out of them, 59 subjects were enrolled in Part 1 and 65 subjects were enrolled in Part 2.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daratumumab 8 mg/kg
    Arm description
    		 Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) via intravenous (IV) route until disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daratumumab 8 mg/kg Q4W as intravenous infusion.

    Arm title
    		 Daratumumab 16 mg/kg
    Arm description
    		 Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W via IV route until disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daratumumab 16 mg/kg weekly for 8 weeks; then Q2W for 16 weeks; then Q4W until disease progression or unacceptable toxicity.

    Number of subjects in period 1
    		Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Started
    18
    106
    Completed
    0
    0
    Not completed
    18
    106
         Consent withdrawn by subject
    2
    7
         Other: study terminated by sponsor
    1
    22
         Lost to follow-up
    -
    8
         Other: death
    15
    69

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Daratumumab 8 mg/kg
    Reporting group description
    		 Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) via intravenous (IV) route until disease progression or unacceptable toxicity.

    Reporting group title
    Daratumumab 16 mg/kg
    Reporting group description
    		 Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W via IV route until disease progression or unacceptable toxicity.

    Reporting group values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg Total
    Number of subjects
    		 18 106 124
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 58 66
        From 65 to 84 years
    		 10 48 58
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.2 ± 7.72 62.9 ± 10 -
    Title for Gender
    Units: subjects
        Female
    		 6 54 60
        Male
    		 12 52 64
    Stage of Disease (ISS)
    The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (<)3.5 milligram/liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin >= 5.5 mg/l.
    Units: Subjects
        stage l
    		 2 26 28
        stage ll
    		 8 40 48
        stage lll
    		 8 40 48
    Number of Prior Lines of Therapy
    Units: Subjects
        <= 3 Lines
    		 6 19 25
        > 3 Lines
    		 12 87 99
    Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory Drug (IMiD)
    Units: Subjects
        Both a PI and IMiD
    		 15 101 116
        PI only
    		 1 3 4
        IMiD only
    		 0 1 1
        None
    		 2 1 3
    Region of Enrollment
    Units: Subjects
        Canada
    		 0 22 22
        Spain
    		 3 9 12
        United States
    		 15 75 90

    End points

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    End points reporting groups
    Reporting group title
    Daratumumab 8 mg/kg
    Reporting group description
    		 Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) via intravenous (IV) route until disease progression or unacceptable toxicity.

    Reporting group title
    Daratumumab 16 mg/kg
    Reporting group description
    		 Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W via IV route until disease progression or unacceptable toxicity.

    Primary: Percentage of Subjects With Overall Response

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    End point title
    		 Percentage of Subjects With Overall Response [1]
    End point description
    Overall response defined as percentage of subjects who achieved complete response (sCR), complete response (CR), very good partial response (VGPR) or (partial response)PR. Per IMWG criteria, sCR: defined as normal (free light chain) FLC ratio, and PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on serum, urine and disappearance of tissue plasmacytomas and < 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hrs; PR: >= 50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >= 90% or to <200 mg/24 hrs; if serum and urine M-protein are not measurable, decrease of >=50% in difference between involved and uninvolved FLC levels is required in place of M-protein criteria. All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    End point type
    Primary
    End point timeframe
    Up to 14.4 Months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    18
    106
    Units: percentage of subjects
        number (confidence interval 95%)
    11.1 (1.4 to 34.7)
    29.2 (20.8 to 38.9)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder. Responders in all treated analysis set. Only those subjects with confirmed PR and those who experienced progressive disease (PD) were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 14.4 Months
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    2 [2]
    31 [3]
    Units: months
        median (confidence interval 95%)
    99999 (1.8 to 99999)
    7.4 (5.5 to 99999)
    Notes
    [2] - 99999: Median and UL of CI were inestimable due to less responders either progressed/died due to PD
    [3] - 99999:Upper limit of CI was inestimable due to less responders either progressed or died due to PD
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    End point type
    Secondary
    End point timeframe
    Approximately up to 3 years
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    18
    106
    Units: months
        median (confidence interval 95%)
    19.45 (7.72 to 26.81)
    18.60 (13.67 to 25.00)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Benefit

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    End point title
    		 Percentage of Subjects With Clinical Benefit
    End point description
    Clinical benefit rate defined as percentage of subjects who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas. All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    End point type
    Secondary
    End point timeframe
    Up to 14.4 Months
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    18
    106
    Units: percentage of subjects
        number (confidence interval 95%)
    22.2 (6.4 to 47.6)
    34.0 (25.0 to 43.8)
    No statistical analyses for this end point

    Secondary: Time to Response

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    End point title
    		 Time to Response
    End point description
    Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Responders in all treated analysis set. Only those subjects with confirmed PR were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 14.4 Months
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    2
    31
    Units: months
        median (full range (min-max))
    0.99 (0.95 to 1.02)
    0.99 (0.9 to 5.6)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. PD as per IMWG criteria:increase of >=25% from lowest response level in Serum M-component and/or(absolute increase must be>=0.5gram/deciliter[g/dL])Urine M-component and/or(absolute increase must be>=200mg/24hr;only in subjects without measurable serum, urine M-protein levels:difference b/w involved, uninvolved FLC levels. Absolute increase must be >10mg/dL;Bone marrow plasma cell%:absolute% must be >=10%;Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions or soft tissue plasmacytomas;Development of hypercalcemia(corrected serum calcium>11.5mg/dL or 2.65millimol/liter[mmol/L])that can be attributed solely to plasma cell proliferative disorder. All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    End point type
    Secondary
    End point timeframe
    Up to 14.4 Months
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    18 [4]
    106
    Units: months
        median (confidence interval 95%)
    4.86 (1.84 to 99999)
    3.65 (2.76 to 4.63)
    Notes
    [4] - 99999: Upper limit of CI was not estimable due to the relatively short duration of follow-up.
    No statistical analyses for this end point

    Secondary: Time to Disease Progression

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    End point title
    		 Time to Disease Progression
    End point description
    Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression. All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    End point type
    Secondary
    End point timeframe
    Up to 14.4 Months
    End point values
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Number of subjects analysed
    18 [5]
    106
    Units: months
        median (confidence interval 95%)
    4.86 (1.84 to 99999)
    3.71 (2.79 to 5.39)
    Notes
    [5] - 99999: Median and upper limit for CI was not estimable' due to less number of subjects with events.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately up to 3.8 years
    Adverse event reporting additional description
    All treated analysis set included all subjects who received at least 1 dose of daratumumab.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Daratumumab 8 mg/kg
    Reporting group description
    		 Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) via intravenous (IV) route until disease progression or unacceptable toxicity.

    Reporting group title
    Daratumumab 16 mg/kg
    Reporting group description
    		 Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W via IV until disease progression or unacceptable toxicity.

    Serious adverse events
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 18 (33.33%)
    33 / 106 (31.13%)
         number of deaths (all causes)
    15
    69
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma Cell Leukaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 106 (4.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 5
    Pyrexia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen Saturation Abnormal
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal Incontinence
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (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
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic Failure
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1n1 Influenza
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 106 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Streptococcal
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 106 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperkalaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daratumumab 8 mg/kg Daratumumab 16 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    105 / 106 (99.06%)
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Hypertension
         subjects affected / exposed
    8 / 18 (44.44%)
    12 / 106 (11.32%)
         occurrences all number
    9
    18
    Hypotension
         subjects affected / exposed
    2 / 18 (11.11%)
    6 / 106 (5.66%)
         occurrences all number
    2
    6
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 18 (11.11%)
    12 / 106 (11.32%)
         occurrences all number
    2
    13
    Chest Discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Chills
         subjects affected / exposed
    6 / 18 (33.33%)
    10 / 106 (9.43%)
         occurrences all number
    7
    10
    Fatigue
         subjects affected / exposed
    6 / 18 (33.33%)
    42 / 106 (39.62%)
         occurrences all number
    6
    47
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 106 (5.66%)
         occurrences all number
    2
    6
    Oedema
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 106 (1.89%)
         occurrences all number
    1
    3
    Oedema Peripheral
         subjects affected / exposed
    2 / 18 (11.11%)
    9 / 106 (8.49%)
         occurrences all number
    3
    12
    Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 106 (5.66%)
         occurrences all number
    1
    6
    Pyrexia
         subjects affected / exposed
    5 / 18 (27.78%)
    20 / 106 (18.87%)
         occurrences all number
    5
    22
    Immune system disorders
    Cytokine Release Syndrome
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Nipple Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    2
    Prostatitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 18 (33.33%)
    27 / 106 (25.47%)
         occurrences all number
    9
    32
    Dyspnoea
         subjects affected / exposed
    3 / 18 (16.67%)
    18 / 106 (16.98%)
         occurrences all number
    5
    18
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 106 (8.49%)
         occurrences all number
    1
    9
    Epistaxis
         subjects affected / exposed
    0 / 18 (0.00%)
    9 / 106 (8.49%)
         occurrences all number
    0
    10
    Nasal Congestion
         subjects affected / exposed
    2 / 18 (11.11%)
    22 / 106 (20.75%)
         occurrences all number
    2
    26
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 106 (8.49%)
         occurrences all number
    1
    11
    Pleural Effusion
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Productive Cough
         subjects affected / exposed
    1 / 18 (5.56%)
    8 / 106 (7.55%)
         occurrences all number
    1
    9
    Throat Irritation
         subjects affected / exposed
    0 / 18 (0.00%)
    7 / 106 (6.60%)
         occurrences all number
    0
    7
    Wheezing
         subjects affected / exposed
    1 / 18 (5.56%)
    7 / 106 (6.60%)
         occurrences all number
    1
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 18 (0.00%)
    8 / 106 (7.55%)
         occurrences all number
    0
    8
    Confusional State
         subjects affected / exposed
    1 / 18 (5.56%)
    7 / 106 (6.60%)
         occurrences all number
    1
    8
    Depression
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Mental Status Changes
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Nervousness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 106 (3.77%)
         occurrences all number
    1
    4
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 106 (3.77%)
         occurrences all number
    3
    4
    Blood Creatinine Increased
         subjects affected / exposed
    7 / 18 (38.89%)
    9 / 106 (8.49%)
         occurrences all number
    7
    21
    Blood Urea Increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Transaminases Increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Weight Decreased
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 106 (4.72%)
         occurrences all number
    2
    6
    Weight Increased
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 106 (3.77%)
         occurrences all number
    1
    5
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 106 (4.72%)
         occurrences all number
    2
    6
    Cardiac disorders
    Sinus Tachycardia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Tachycardia
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Nervous system disorders
    Anaesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
    10 / 106 (9.43%)
         occurrences all number
    1
    12
    Dysgeusia
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 106 (2.83%)
         occurrences all number
    2
    3
    Encephalopathy
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    2 / 18 (11.11%)
    13 / 106 (12.26%)
         occurrences all number
    2
    17
    Hypoaesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 106 (5.66%)
         occurrences all number
    1
    7
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 106 (5.66%)
         occurrences all number
    1
    7
    Sciatica
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 106 (1.89%)
         occurrences all number
    3
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 18 (50.00%)
    39 / 106 (36.79%)
         occurrences all number
    20
    101
    Leukopenia
         subjects affected / exposed
    2 / 18 (11.11%)
    8 / 106 (7.55%)
         occurrences all number
    2
    18
    Lymphopenia
         subjects affected / exposed
    3 / 18 (16.67%)
    5 / 106 (4.72%)
         occurrences all number
    6
    10
    Neutropenia
         subjects affected / exposed
    2 / 18 (11.11%)
    26 / 106 (24.53%)
         occurrences all number
    4
    56
    Thrombocytopenia
         subjects affected / exposed
    6 / 18 (33.33%)
    28 / 106 (26.42%)
         occurrences all number
    17
    71
    Ear and labyrinth disorders
    Cerumen Impaction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Ear Discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    4
    Abdominal Distension
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Abdominal Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    7 / 106 (6.60%)
         occurrences all number
    1
    8
    Aphthous Stomatitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 18 (5.56%)
    19 / 106 (17.92%)
         occurrences all number
    1
    21
    Diarrhoea
         subjects affected / exposed
    4 / 18 (22.22%)
    22 / 106 (20.75%)
         occurrences all number
    5
    31
    Dry Mouth
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    4 / 18 (22.22%)
    34 / 106 (32.08%)
         occurrences all number
    5
    39
    Vomiting
         subjects affected / exposed
    2 / 18 (11.11%)
    19 / 106 (17.92%)
         occurrences all number
    2
    22
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic Keratosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Nail Discolouration
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Rash
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 106 (1.89%)
         occurrences all number
    1
    2
    Rash Macular
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Bladder Spasm
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 106 (1.89%)
         occurrences all number
    2
    2
    Micturition Urgency
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Urinary Incontinence
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 106 (0.94%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 18 (11.11%)
    20 / 106 (18.87%)
         occurrences all number
    2
    23
    Back Pain
         subjects affected / exposed
    5 / 18 (27.78%)
    25 / 106 (23.58%)
         occurrences all number
    5
    27
    Bone Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    10 / 106 (9.43%)
         occurrences all number
    0
    12
    Flank Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Muscle Spasms
         subjects affected / exposed
    2 / 18 (11.11%)
    9 / 106 (8.49%)
         occurrences all number
    3
    10
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 18 (11.11%)
    15 / 106 (14.15%)
         occurrences all number
    2
    16
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    12 / 106 (11.32%)
         occurrences all number
    1
    14
    Myalgia
         subjects affected / exposed
    0 / 18 (0.00%)
    6 / 106 (5.66%)
         occurrences all number
    0
    8
    Pain in Extremity
         subjects affected / exposed
    1 / 18 (5.56%)
    20 / 106 (18.87%)
         occurrences all number
    1
    22
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 18 (0.00%)
    7 / 106 (6.60%)
         occurrences all number
    0
    9
    Candida Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 106 (3.77%)
         occurrences all number
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    8 / 106 (7.55%)
         occurrences all number
    1
    11
    Pneumonia
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 106 (3.77%)
         occurrences all number
    1
    5
    Sinusitis
         subjects affected / exposed
    1 / 18 (5.56%)
    7 / 106 (6.60%)
         occurrences all number
    1
    11
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 18 (11.11%)
    21 / 106 (19.81%)
         occurrences all number
    3
    32
    Urinary Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    7 / 106 (6.60%)
         occurrences all number
    0
    7
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    4 / 18 (22.22%)
    19 / 106 (17.92%)
         occurrences all number
    4
    21
    Fluid Retention
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    2 / 18 (11.11%)
    16 / 106 (15.09%)
         occurrences all number
    4
    28
    Hyperglycaemia
         subjects affected / exposed
    3 / 18 (16.67%)
    9 / 106 (8.49%)
         occurrences all number
    3
    15
    Hyperkalaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Hyperuricaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 106 (3.77%)
         occurrences all number
    1
    4
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 18 (22.22%)
    5 / 106 (4.72%)
         occurrences all number
    5
    6
    Hypocalcaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 106 (2.83%)
         occurrences all number
    2
    9
    Hypoglycaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 106 (0.94%)
         occurrences all number
    1
    3
    Hypokalaemia
         subjects affected / exposed
    4 / 18 (22.22%)
    11 / 106 (10.38%)
         occurrences all number
    4
    17
    Hypomagnesaemia
         subjects affected / exposed
    2 / 18 (11.11%)
    8 / 106 (7.55%)
         occurrences all number
    2
    19
    Hyponatraemia
         subjects affected / exposed
    6 / 18 (33.33%)
    7 / 106 (6.60%)
         occurrences all number
    7
    7
    Hypophosphataemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    Metabolic Acidosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2013
    The overall reason for the amendment was to include the following changes: the sample size was increased to approximately 20 subjects per treatment group in Part 1 Stage 1 from an original 15 subjects, the study agent administration guidelines were changed from mg/hr to mL/hr, and minor additional changes were made for clarification throughout the protocol.
    07 Feb 2014
    The overall reason for the amendment was to include the following changes: following the discontinuation of the dose schedule of 8 mg/kg every 4 weeks (Treatment Group B) at the end of Stage 1, the number of subjects in Part 2 was increased to approximately 60 subjects, biomarker sampling time points were modified, and subjects in Group B were allowed to crossover to Group A.
    09 Jul 2014
    The overall reason for the amendment was to change the timing of the on treatment bone marrow biopsy.
    08 Jun 2015
    The overall reason for the amendment was to allow subjects who are benefiting from daratumamab to continue to receive study treatment beyond the previously defined end of study.

    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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