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    Clinical Trial Results:
    A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

    Summary
    EudraCT number
    		 2018-004252-38
    Trial protocol
    		 GB   NL   DE   FR   ES   BE   HU   GR   PL   BG   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2023
    First version publication date
    27 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    207495
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04162210
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 GreatWest Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    Interim
    Date of interim/final analysis
    04 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Sep 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy with belantamab mafodotin vs pomalidomide plus low dose dexamethasone (pom/dex) in participants with relapsed/refractory multiple myeloma (RRMM)
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2020
    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: 32
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Brazil: 37
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    China: 33
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 39
    Country: Number of subjects enrolled
    Hungary: 26
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Russian Federation: 32
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    325
    EEA total number of subjects
    132
    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)
    124
    From 65 to 84 years
    197
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The results presented are based on the primary analysis (and includes data up to a maximum of 27 months). Data collection is still ongoing and additional results will be provided after study completion.

    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
    		 Belantamab mafodotin
    Arm description
    		 Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with relapsed/refractory multiple myeloma (RRMM) received intravenous solution of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin as single agent on day 1 of every 21-day cycle up to approximately 23 months.

    Arm title
    		 Pomalidomide plus Dexamethasone
    Arm description
    		 Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, with 40 mg or at lower 20 mg dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, with 40 mg or at lower 20 mg dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.

    Number of subjects in period 1
    		Belantamab mafodotin Pomalidomide plus Dexamethasone
    Started
    218
    107
    Safety Population
    217
    102
    Completed
    84
    38
    Not completed
    134
    69
         Consent withdrawn by subject
    17
    9
         Ongoing
    113
    59
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belantamab mafodotin
    Reporting group description
    		 Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.

    Reporting group title
    Pomalidomide plus Dexamethasone
    Reporting group description
    		 Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.

    Reporting group values
    		 Belantamab mafodotin Pomalidomide plus Dexamethasone Total
    Number of subjects
    		 218 107 325
    Age categorical
    Units: Subjects
        <65 years
    		 81 43 124
        >=65 to <75 years
    		 90 41 131
        >=75 years
    		 47 23 70
    Sex: Female, Male
    Units: Participants
        Female
    		 100 41 141
        Male
    		 118 66 184
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 47 19 66
        Black Or African American
    		 3 1 4
        White
    		 162 84 246
        Not Reported
    		 6 3 9
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 66.3 ( 9.67 ) 66.6 ( 9.68 ) -

    End points

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    End points reporting groups
    Reporting group title
    Belantamab mafodotin
    Reporting group description
    		 Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.

    Reporting group title
    Pomalidomide plus Dexamethasone
    Reporting group description
    		 Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.

    Primary: Progression-free survival (PFS) based on investigator-assessed response as per international myeloma working group (IMWG)

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    End point title
    		 Progression-free survival (PFS) based on investigator-assessed response as per international myeloma working group (IMWG)
    End point description
    PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
    End point type
    Primary
    End point timeframe
    Up to 27 months
    End point values
    		 Belantamab mafodotin Pomalidomide plus Dexamethasone
    Number of subjects analysed
    218
    107
    Units: Months
        median (confidence interval 95%)
    11.2 (6.4 to 14.5)
    7.0 (4.6 to 10.6)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.
    Comparison groups
    Belantamab mafodotin v Pomalidomide plus Dexamethasone
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.558 [1]
    Method
    		 Logrank
    Parameter type
    		 Stratified Hazard Ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.47
    Notes
    [1] - One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause deaths, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion.
    Adverse event reporting additional description
    All cause deaths, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Pomalidomide plus Dexamethasone
    Reporting group description
    		 Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.

    Reporting group title
    Belantamab mafodotin
    Reporting group description
    		 Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.

    Serious adverse events
    		 Pomalidomide plus Dexamethasone Belantamab mafodotin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    40 / 102 (39.22%)
    94 / 217 (43.32%)
         number of deaths (all causes)
    38
    83
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone neoplasm
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Plasma cell myeloma
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Bowen's disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Shock haemorrhagic
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    Pyrexia
         subjects affected / exposed
    0 / 102 (0.00%)
    7 / 217 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device extrusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 102 (0.00%)
    4 / 217 (1.84%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (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
    Femur fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 102 (0.00%)
    4 / 217 (1.84%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Road traffic accident
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hip fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperammonaemic encephalopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    Thrombocytopenia
         subjects affected / exposed
    1 / 102 (0.98%)
    8 / 217 (3.69%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    5 / 217 (2.30%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    5 / 102 (4.90%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal compartment syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    Pathological fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    8 / 102 (7.84%)
    6 / 217 (2.76%)
         occurrences causally related to treatment / all
    6 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    COVID-19
         subjects affected / exposed
    3 / 102 (2.94%)
    5 / 217 (2.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 217 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    Osteomyelitis
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    5 / 102 (4.90%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spontaneous bacterial peritonitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         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
    1 / 102 (0.98%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary nocardiosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pomalidomide plus Dexamethasone Belantamab mafodotin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 102 (86.27%)
    200 / 217 (92.17%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 102 (1.96%)
    13 / 217 (5.99%)
         occurrences all number
    2
    13
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    10 / 102 (9.80%)
    6 / 217 (2.76%)
         occurrences all number
    12
    7
    Chills
         subjects affected / exposed
    0 / 102 (0.00%)
    13 / 217 (5.99%)
         occurrences all number
    0
    16
    Fatigue
         subjects affected / exposed
    15 / 102 (14.71%)
    18 / 217 (8.29%)
         occurrences all number
    15
    19
    Pyrexia
         subjects affected / exposed
    9 / 102 (8.82%)
    34 / 217 (15.67%)
         occurrences all number
    11
    47
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    7 / 102 (6.86%)
    9 / 217 (4.15%)
         occurrences all number
    13
    9
    Epistaxis
         subjects affected / exposed
    2 / 102 (1.96%)
    11 / 217 (5.07%)
         occurrences all number
    2
    12
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 102 (4.90%)
    30 / 217 (13.82%)
         occurrences all number
    8
    32
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 102 (0.00%)
    33 / 217 (15.21%)
         occurrences all number
    0
    37
    Neutrophil count decreased
         subjects affected / exposed
    14 / 102 (13.73%)
    17 / 217 (7.83%)
         occurrences all number
    34
    35
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 102 (4.90%)
    22 / 217 (10.14%)
         occurrences all number
    6
    24
    Platelet count decreased
         subjects affected / exposed
    12 / 102 (11.76%)
    27 / 217 (12.44%)
         occurrences all number
    19
    32
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 102 (7.84%)
    14 / 217 (6.45%)
         occurrences all number
    17
    16
    Lymphocyte count decreased
         subjects affected / exposed
    6 / 102 (5.88%)
    8 / 217 (3.69%)
         occurrences all number
    9
    15
    Blood creatinine increased
         subjects affected / exposed
    6 / 102 (5.88%)
    10 / 217 (4.61%)
         occurrences all number
    7
    11
    White blood cell count decreased
         subjects affected / exposed
    9 / 102 (8.82%)
    12 / 217 (5.53%)
         occurrences all number
    21
    19
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 102 (0.00%)
    15 / 217 (6.91%)
         occurrences all number
    0
    25
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    30 / 102 (29.41%)
    61 / 217 (28.11%)
         occurrences all number
    37
    78
    Neutropenia
         subjects affected / exposed
    39 / 102 (38.24%)
    24 / 217 (11.06%)
         occurrences all number
    86
    47
    Leukopenia
         subjects affected / exposed
    9 / 102 (8.82%)
    7 / 217 (3.23%)
         occurrences all number
    19
    8
    Thrombocytopenia
         subjects affected / exposed
    31 / 102 (30.39%)
    70 / 217 (32.26%)
         occurrences all number
    61
    98
    Lymphopenia
         subjects affected / exposed
    7 / 102 (6.86%)
    5 / 217 (2.30%)
         occurrences all number
    24
    8
    Eye disorders
    Eye irritation
         subjects affected / exposed
    1 / 102 (0.98%)
    50 / 217 (23.04%)
         occurrences all number
    2
    87
    Visual acuity reduced
         subjects affected / exposed
    1 / 102 (0.98%)
    41 / 217 (18.89%)
         occurrences all number
    1
    97
    Eye pain
         subjects affected / exposed
    0 / 102 (0.00%)
    35 / 217 (16.13%)
         occurrences all number
    0
    54
    Keratopathy
         subjects affected / exposed
    1 / 102 (0.98%)
    26 / 217 (11.98%)
         occurrences all number
    1
    29
    Punctate keratitis
         subjects affected / exposed
    0 / 102 (0.00%)
    23 / 217 (10.60%)
         occurrences all number
    0
    44
    Visual impairment
         subjects affected / exposed
    0 / 102 (0.00%)
    13 / 217 (5.99%)
         occurrences all number
    0
    25
    Cataract
         subjects affected / exposed
    5 / 102 (4.90%)
    12 / 217 (5.53%)
         occurrences all number
    6
    14
    Keratitis
         subjects affected / exposed
    0 / 102 (0.00%)
    12 / 217 (5.53%)
         occurrences all number
    0
    14
    Foreign body sensation in eyes
         subjects affected / exposed
    2 / 102 (1.96%)
    57 / 217 (26.27%)
         occurrences all number
    2
    129
    Dry eye
         subjects affected / exposed
    2 / 102 (1.96%)
    61 / 217 (28.11%)
         occurrences all number
    2
    116
    Vision blurred
         subjects affected / exposed
    2 / 102 (1.96%)
    86 / 217 (39.63%)
         occurrences all number
    2
    172
    Photophobia
         subjects affected / exposed
    1 / 102 (0.98%)
    46 / 217 (21.20%)
         occurrences all number
    1
    64
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 102 (0.98%)
    16 / 217 (7.37%)
         occurrences all number
    1
    22
    Diarrhoea
         subjects affected / exposed
    11 / 102 (10.78%)
    22 / 217 (10.14%)
         occurrences all number
    14
    27
    Nausea
         subjects affected / exposed
    4 / 102 (3.92%)
    25 / 217 (11.52%)
         occurrences all number
    8
    32
    Constipation
         subjects affected / exposed
    9 / 102 (8.82%)
    12 / 217 (5.53%)
         occurrences all number
    10
    12
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 102 (0.00%)
    11 / 217 (5.07%)
         occurrences all number
    0
    14
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 102 (5.88%)
    4 / 217 (1.84%)
         occurrences all number
    6
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 102 (8.82%)
    20 / 217 (9.22%)
         occurrences all number
    9
    22
    Back pain
         subjects affected / exposed
    10 / 102 (9.80%)
    13 / 217 (5.99%)
         occurrences all number
    11
    15
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 102 (1.96%)
    12 / 217 (5.53%)
         occurrences all number
    2
    17
    COVID-19
         subjects affected / exposed
    9 / 102 (8.82%)
    24 / 217 (11.06%)
         occurrences all number
    9
    24
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    6 / 102 (5.88%)
    6 / 217 (2.76%)
         occurrences all number
    7
    6
    Hypokalaemia
         subjects affected / exposed
    3 / 102 (2.94%)
    14 / 217 (6.45%)
         occurrences all number
    4
    16

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2020
    This protocol amendment was implemented following regulatory agency input and a review of data from the Phase 2 DREAMM-2 study. This amendment addressed specifically the rules for dose modification.
    20 Sep 2021
    This protocol amendment included an update to the planned PFS futility interim analysis.
    21 Oct 2021
    The protocol amendment increased the global enrollment cap (limit) for participants who have received ≤3 prior lines from 40% to 55%.
    20 Apr 2022
    This protocol amendment was issued after the timeframe for study completion was re-estimated based on the current accrual rate of PFS events, which were slower than originally anticipated.
    07 Sep 2022
    Amendment included updates to the method for the primary analysis of efficacy endpoints from being based on algorithm-derived confirmed response and dates per International Myeloma Working Group (IMWG).

    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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    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
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