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    Clinical Trial Results:
    An Open-Label, Rollover Protocol for Participants Previously Enrolled in Takeda-Sponsored Ixazomib Studies

    Summary
    EudraCT number
    		 2016-001681-28
    Trial protocol
    		 ES   BE   SE   GR   PL  
    Global end of trial date
    03 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2025
    First version publication date
    13 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C16027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02924272
    WHO universal trial number (UTN)
    		 U1111-1184-2041
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Avenue, Lexington, MA, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.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
    03 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to provide continued access of ixazomib and to evaluate the long-term safety profile of ixazomib.
    Protection of trial subjects
    All study participants were required to read and sign an informed consent form (ICF).
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    16 Dec 2016
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Japan: 1
    Worldwide total number of subjects
    32
    EEA total number of subjects
    21
    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)
    7
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at various investigative sites globally from 16 December 2016 to 03 July 2024.

    Pre-assignment
    Screening details
    		 Participants who had previously received and tolerated treatment in ixazomib parent studies (C16003, C16005, C16006, C16007, C16008, C16010 Global, C16011, C16013, C16014 Global and Korean Continuation, C16017, C16020, C16029, or C16047), and in investigator’s opinion could benefit from continued therapy were enrolled.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Ixazomib Monotherapy
    Arm description
    		 Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixazomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ixazomib capsule, orally at the same doses as they were receiving in the parent study.

    Arm title
    		 Ixazomib Combination Therapy
    Arm description
    		 Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixazomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose as they were receiving in the parent study.

    Number of subjects in period 1
    		Ixazomib Monotherapy Ixazomib Combination Therapy
    Started
    23
    9
    Completed
    0
    0
    Not completed
    23
    9
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    -
         Clinical Deterioration
    1
    -
         Adverse event, non-fatal
    3
    -
         Reason Not Specified
    1
    -
         Progressive Disease
    11
    8
         Site Terminated by Sponsor
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ixazomib Monotherapy
    Reporting group description
    		 Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.

    Reporting group title
    Ixazomib Combination Therapy
    Reporting group description
    		 Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.

    Reporting group values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy Total
    Number of subjects
    		 23 9
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 75.1 ( 6.45 ) 64.6 ( 9.53 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 5 16
        Male
    		 12 4 16

    End points

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    End points reporting groups
    Reporting group title
    Ixazomib Monotherapy
    Reporting group description
    		 Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.

    Reporting group title
    Ixazomib Combination Therapy
    Reporting group description
    		 Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.

    Primary: Number of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Number of subjects analysed
    23
    9
    Units: participants
    12
    4
    No statistical analyses for this end point

    Primary: Number of Participants With ≥ Grade 3 AEs

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    End point title
    		 Number of Participants With ≥ Grade 3 AEs [2]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE. Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    Notes
    [2] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Number of subjects analysed
    23
    9
    Units: participants
    13
    5
    No statistical analyses for this end point

    Primary: Number of Participants With ≥ Grade 2 Peripheral Neuropathy

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    End point title
    		 Number of Participants With ≥ Grade 2 Peripheral Neuropathy [3]
    End point description
    Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated. Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    Notes
    [3] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Number of subjects analysed
    23
    9
    Units: participants
    2
    0
    No statistical analyses for this end point

    Primary: Number of Participants With New Primary Malignancies

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    End point title
    		 Number of Participants With New Primary Malignancies [4]
    End point description
    Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Number of subjects analysed
    23
    9
    Units: participants
    3
    1
    No statistical analyses for this end point

    Primary: Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug

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    End point title
    		 Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug [5]
    End point description
    An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    End point type
    Primary
    End point timeframe
    Up to 7 years
    Notes
    [5] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Number of subjects analysed
    23
    9
    Units: participants
        AE Resulting in Dose Modification
    12
    7
        AE Resulting in Discontinuation of Study Drug
    4
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 years
    Adverse event reporting additional description
    The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Ixazomib Monotherapy
    Reporting group description
    		 Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.

    Reporting group title
    Ixazomib Combination Therapy
    Reporting group description
    		 Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.

    Serious adverse events
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 23 (52.17%)
    4 / 9 (44.44%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Sebaceous carcinoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (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
    Bladder injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         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 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (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
    Asthma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 9 (33.33%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 9 (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
    		 Ixazomib Monotherapy Ixazomib Combination Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 23 (39.13%)
    6 / 9 (66.67%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 9 (0.00%)
         occurrences all number
    6
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Anaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    Neutropenia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    Tooth abscess
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 9 (33.33%)
         occurrences all number
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2017
    The following changes were made as per Amendment 01: 1. Added allowance for study drug administration to be rounded and/or converted from body surface area (BSA)-based dosing to fixed dosing with approval from the medical monitor. 2. Specified that local safety-related laboratory and vital signs assessments would be performed as presented in this study, rather than in the parent study. 3. Provided additional dose administration instructions. 4. Updated storage and handling instructions to be consistent with current ixazomib investigator’s brochure (IB). 5. Added allowance for on-site monitoring visits. 6. Added allowance for study drug to be dispensed for up to 3 cycles at a distribution at the discretion of the investigator.
    03 Jun 2021
    The following changes were made as per Amendment 03: 1. Updated the background information on other ixazomib clinical trials. 2. Updated the criteria for withdrawing participants from study. 3. Added information about alternative monitoring approaches, such as remote source data verification, in the event a monitor could not visit the site in a timely manner due to the coronavirus disease 2019 (COVID-19) pandemic.

    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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