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    Clinical Trial Results:
    A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma

    Summary
    EudraCT number
    		 2017-004232-11
    Trial protocol
    		 ES  
    Global end of trial date
    24 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2021
    First version publication date
    25 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M16-085
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03567616
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    24 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in subjects with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the last treatment regimen. The study was designed to have 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). Part 2 subjects were to be divided into 2 cohorts, those positive and negative for t(11;14) translocation. After primary progression-free survival (PFS) analysis of EudraCT 2015-004411-20, MM studies were placed on partial clinical hold (PCH) by US FDA. Sponsor did not pursue PCH release for this study; subjects in Part 1 deriving clinical benefit were allowed to continue to receive treatment until disease progression. The study was discontinued when the last participant completed study treatment. No participants were enrolled in Part 2.
    Protection of trial subjects
    Subjects must have voluntarily signed and dated an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), before the initiation of any screening or study-specific procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    8
    EEA total number of subjects
    1
    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)
    2
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Full Analysis Set: participants who received at least 1 dose of study drug

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

    Arms
    Arm title
    		 All Participants
    Arm description
    		 Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    Other name
    ABT-199, GDC-0199, Venclexta
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg oral [PO], once daily [QD]

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pomalyst
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg oral [PO], once daily [QD]

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg once weekly [qw]. For participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]

    Number of subjects in period 1
    		All Participants
    Started
    8
    Completed
    0
    Not completed
    8
         Physician decision
    1
         Disease progression
    4
         Adverse event, non-fatal
    1
         Death
    1
         Withdrawal by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 67.5 (60 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 3 3
    Subject analysis sets

    Subject analysis set title
    Participants Positive for t(11;14) Translocation
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Subject analysis set title
    Participants Negative for t(11;14) Translocation
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Subject analysis sets values
    		 Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects
    3
    5
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    68.0 (67 to 74)
    66.0 (60 to 77)
    Gender categorical
    Units: Subjects
        Female
    1
    4
        Male
    2
    1

    End points

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    End points reporting groups
    Reporting group title
    All Participants
    Reporting group description
    		 Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Subject analysis set title
    Participants Positive for t(11;14) Translocation
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Subject analysis set title
    Participants Negative for t(11;14) Translocation
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Primary: Number of Participants With Adverse Events

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    End point title
    		 Number of Participants With Adverse Events [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
    End point type
    Primary
    End point timeframe
    From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)
    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 data are summarized for this endpoint per protocol
    End point values
    		 Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects analysed
    3 [2]
    5 [3]
    Units: participants
        Any TEAE
    3
    5
        TESAE
    3
    2
    Notes
    [2] - Safety Analysis Set: participants who received at least 1 dose of study drug
    [3] - Safety Analysis Set: participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [4]
    End point description
    ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
    End point type
    Primary
    End point timeframe
    Approximately 15 months
    Notes
    [4] - 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: This was a dose escalation and expansion single arm trial, with the primary focus on safety. Efficacy endpoints were of lesser priority, with no preplanned statistical analyses.
    End point values
    		 All Participants Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects analysed
    8 [5]
    3 [6]
    5 [7]
    Units: percentage of participants
        number (confidence interval 95%)
    62.5 (24.5 to 91.5)
    66.7 (9.4 to 99.2)
    60.0 (14.7 to 94.7)
    Notes
    [5] - Full Analysis Set: participants who received at least 1 dose of study drug
    [6] - Full Analysis Set: participants who received at least 1 dose of study drug
    [7] - Full Analysis Set: participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR for a given participant is defined as the number of days from the date of that participant’s first documented response (Partial Response [PR] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant’s data was to be censored. 00000 and 99999 in the table below indicate values that are not calculable/estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Approximately 15 months
    End point values
    		 All Participants Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects analysed
    5 [8]
    2 [9]
    3 [10]
    Units: days
        median (confidence interval 95%)
    393.0 (00000 to 99999)
    393.0 (00000 to 99999)
    00000 (00000 to 99999)
    Notes
    [8] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    [9] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    [10] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    No statistical analyses for this end point

    Secondary: Time-to-progression (TTP)

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    End point title
    		 Time-to-progression (TTP)
    End point description
    TTP for a given participant is defined as the number of days from the date of first dose to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant did not have an event of PD and the participant had not died due to MM, the participant’s data was to be censored. 00000 and 99999 in the table below indicate values that are not calculable/estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Approximately 15 months
    End point values
    		 All Participants Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects analysed
    8 [11]
    3 [12]
    5 [13]
    Units: days
        median (confidence interval 95%)
    420.0 (57.0 to 99999)
    420.0 (00000 to 99999)
    99999 (57.0 to 99999)
    Notes
    [11] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    [12] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    [13] - FAS: subjects rcvd ≥1 dose of study drug + had disease progression or death due to multiple myeloma
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS is defined as the number of days from the date of first dose of any study drug to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug. 99999 in the table below indicates values that are not calculable/estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Approximately 20 months
    End point values
    		 All Participants Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Number of subjects analysed
    8 [14]
    3 [15]
    5 [16]
    Units: days
        median (confidence interval 95%)
    320.0 (11.0 to 99999)
    220.0 (11.0 to 99999)
    99999 (57.0 to 99999)
    Notes
    [14] - Full Analysis Set: participants who received at least 1 dose of study drug
    [15] - Full Analysis Set: participants who received at least 1 dose of study drug
    [16] - Full Analysis Set: participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 70 weeks.
    Adverse event reporting additional description
    TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Participants Positive for t(11;14) Translocation
    Reporting group description
    		 Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Reporting group title
    Participants Negative for t(11;14) Translocation
    Reporting group description
    		 Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

    Serious adverse events
    		 Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 5 (40.00%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Investigations
    BLOOD LACTATE DEHYDROGENASE INCREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PANCREATIC NEOPLASM
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         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
    1 / 3 (33.33%)
    0 / 5 (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
    CEREBRAL INFARCTION
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (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
    PNEUMOCOCCAL INFECTION
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         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 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA STREPTOCOCCAL
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Participants Positive for t(11;14) Translocation Participants Negative for t(11;14) Translocation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    2
    2
    HYPOTENSION
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 5 (40.00%)
         occurrences all number
    3
    3
    CHILLS
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    PYREXIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    VULVOVAGINAL PRURITUS
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    DYSPHONIA
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    DYSPNOEA
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 5 (20.00%)
         occurrences all number
    3
    1
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    NASAL CONGESTION
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    RESPIRATORY ACIDOSIS
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    INSOMNIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    BLOOD IMMUNOGLOBULIN G DECREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    BLOOD LACTATE DEHYDROGENASE INCREASED
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    5
    PLATELET COUNT DECREASED
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    5
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    15
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    APHASIA
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    DIZZINESS
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    DISTURBANCE IN ATTENTION
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    DYSGEUSIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    PARAESTHESIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    TREMOR
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 5 (60.00%)
         occurrences all number
    1
    4
    LEUKOPENIA
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 5 (40.00%)
         occurrences all number
    3
    14
    NEUTROPENIA
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 5 (80.00%)
         occurrences all number
    10
    34
    LYMPHOPENIA
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    6
    THROMBOCYTOPENIA
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 5 (40.00%)
         occurrences all number
    1
    6
    Ear and labyrinth disorders
    EAR DISCOMFORT
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    DIARRHOEA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    FLATULENCE
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    NAUSEA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    VOMITING
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    TOOTHACHE
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    ERYTHEMA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    RASH
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    BACK PAIN
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    BONE PAIN
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    FLANK PAIN
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    MYALGIA
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    NECK PAIN
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Infections and infestations
    HERPES ZOSTER
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    BRONCHITIS
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    3
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 5 (60.00%)
         occurrences all number
    0
    3
    HYPERKALAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    HYPERURICAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    HYPOALBUMINAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    HYPOGLYCAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 5 (60.00%)
         occurrences all number
    1
    5
    HYPOMAGNESAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 5 (40.00%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jun 2018
    Version 2.0 • Included recent data from a study of venetoclax in combination with a proteasome inhibitor (Study M14-031, Bellini study) where a higher proportion of deaths possibly related to infections was observed in the venetoclax arm • Updated eligibility Criterion 14 (Section 5.1) and the synopsis (Section 1) • Modified Section 5.4 to provide guidance on vaccinations while on study • Modified Section 6.4 to strongly recommend consideration of G-CSF • Modified Section 6.4 (Management of Infections) to strongly recommend close monitoring of infections during subject study participation including treatment modification recommendations • Modified Table 10 (Toxicities Related to Venetoclax) to keep consistency with modifications mentioned above
    15 Mar 2019
    Version 3.0 • Updated Section 4.1 to modify dosing instructions
    02 Oct 2019
    Version 4.0 • Clarified allowable corticosteroid use while on study treatment • Based on BELLINI interim analysis, recommendations provided for the use of and the timing for prophylactic antibiotics; in addition, recommendations provided for the administration of intravenous immunoglobulin (IVIG) • Provided further guidance on vaccinations and to align with recommendations set forth by the National Comprehensive Cancer Network (NCCN) and the Center for Disease Control (CDC) in patients with multiple myeloma • Provided further guidance for tumor lysis syndrome (TLS) prophylaxis • Provided instruction for dispensing of pomalidomide • Provided AEs of special interest • Referenced a Safety Review Committee (SRC) separate from the study team that will provide regular review of safety data • Included progression-free survival follow-up visits • Included survival follow-up assessments
    24 Jun 2020
    Version 5.0 • Updated pneumococcal and influenza vaccination requirements • Updated the list of signatories in Appendix C per current standard operating procedure • Deleted the progression-free survival follow-up visits • Deleted the survival follow-up assessments

    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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