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    Clinical Trial Results:
    A MULTICENTER, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

    Summary
    EudraCT number
    		 2010-021111-17
    Trial protocol
    		 IT  
    Global end of trial date
    31 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2023
    First version publication date
    28 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IST-CAR-506
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01346787
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    STICHTING EUROPEAN MYELOMA NETWORK
    Sponsor organisation address
    Dr. Molewaterplein 40, ROTTERDAM, Netherlands, 3015 GD
    Public contact
    Clinical Trial Office, Fondazione EMN Italy Onlus, 0039 0110243236, clinicaltrialoffice@emnitaly.org
    Scientific contact
    Clinical Trial Office, Fondazione EMN Italy Onlus, 0039 0110243236, clinicaltrialoffice@emnitaly.org
    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
    31 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine whether the association of Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides benefits in patients with newly diagnosed MM.
    Protection of trial subjects
    The protocol for this study has been designed in accordance with the general ethical principles outlined in the Declaration of Helsinki. The review of this protocol by the IRB/EC and the performance of all aspects of the study, including the methods used for obtaining informed consent, must also be in accordance with principles enunciated in the declaration, as well as ICH Guidelines, Title 21 of the Code of Federal Regulations (CFR), Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    1
    From 65 to 84 years
    56
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This protocol is a phase II multicenter, international, non comparative, open label study designed to assess the safety and the efficacy of the association Carfilxomib with Cyclophosphamide and Deaxamethasone (CCd) as induction treatment in newly diagnosed MM patients.

    Pre-assignment
    Screening details
    		 The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria.

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

    Arms
    Arm title
    		 CCd arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carflizomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 36 mg/ m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 36 mg/ m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Each cycle will be repeated every 28 days for a total of 9 courses.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    Low dose Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23

    Number of subjects in period 1
    		CCd arm
    Started
    58
    Completed
    0
    Not completed
    58
         Adverse event, serious fatal
    4
         Consent withdrawn by subject
    7
         Physician decision
    1
         Adverse event, non-fatal
    22
         Trial closured by sponsor
    1
         Lost to follow-up
    2
         Lack of efficacy
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ITT
    Reporting group description
    		 -

    Reporting group values
    		 ITT Total
    Number of subjects
    		 58 58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 56 56
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 71 (55 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 27 27
    ISS Stage
    Units: Subjects
        ISS Stage I
    		 16 16
        ISS Stage II
    		 19 19
        ISS Stage III
    		 23 23
    ECOG
    Units: Subjects
        ECOG 0
    		 24 24
        ECOG 1
    		 30 30
        ECOG 2
    		 4 4
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis sets values
    		 ITT
    Number of subjects
    58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1
        From 65-84 years
    56
        85 years and over
    1
    Age continuous
    Units: years
        median (full range (min-max))
    71 (55 to 86)
    Gender categorical
    Units: Subjects
        Female
    31
        Male
    27
    ISS Stage
    Units: Subjects
        ISS Stage I
    16
        ISS Stage II
    19
        ISS Stage III
    23
    ECOG
    Units: Subjects
        ECOG 0
    24
        ECOG 1
    30
        ECOG 2
    4

    End points

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    End points reporting groups
    Reporting group title
    CCd arm
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Primary: PR Rate

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    End point title
    		 PR Rate
    End point description
    End point type
    Primary
    End point timeframe
    PR Rate
    End point values
    		 CCd arm ITT
    Number of subjects analysed
    58
    58
    Units: subjects
    49
    49
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    CCd arm v ITT
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    49
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 49
         upper limit
    		 49
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - No statistical analysis
    [2] - No statistical analysis

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Progression free survival
    End point values
    		 CCd arm ITT
    Number of subjects analysed
    58
    58
    Units: month
        median (confidence interval 95%)
    35.5 (27.7 to 67)
    35.5 (27.7 to 67)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    CCd arm v ITT
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 43
         upper limit
    		 43
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [3] - No statistical analysis
    [4] - No statistical analysis

    Secondary: Time to progression

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    End point title
    		 Time to progression
    End point description
    End point type
    Secondary
    End point timeframe
    Time to progression
    End point values
    		 CCd arm ITT
    Number of subjects analysed
    58
    58
    Units: month
        median (confidence interval 95%)
    46.6 (34.5 to 72.4)
    46.6 (34.5 to 72.4)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    CCd arm v ITT
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    46.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 46.6
         upper limit
    		 46.6
    Variability estimate
    Standard error of the mean
    Notes
    [5] - No statistical analysis
    [6] - No statistical analysis

    Secondary: Time to next therapy

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    End point title
    		 Time to next therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Time to next therapy
    End point values
    		 CCd arm ITT
    Number of subjects analysed
    58
    58
    Units: month
        median (confidence interval 95%)
    43 (28 to 55.1)
    43 (28 to 55.1)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    CCd arm v ITT
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0 [8]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 43
         upper limit
    		 43
    Variability estimate
    Standard deviation
    Notes
    [7] - No statistical analysis
    [8] - No statistical analysis

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall survival
    End point values
    		 CCd arm ITT
    Number of subjects analysed
    58
    58
    Units: month
        median (confidence interval 95%)
    78 (52.1 to 78)
    78 (52.1 to 78)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    CCd arm v ITT
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 78
         upper limit
    		 78
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [9] - No statistical analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Per protocol
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Per Protocol
    Reporting group description
    		 -

    Serious adverse events
    		 Per Protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 58 (36.21%)
         number of deaths (all causes)
    30
         number of deaths resulting from adverse events
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell leukemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Ischaemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Myocardial ischaemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorder
    Additional description: decompensation cardiac
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileal perforation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nausea
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Oliguria
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Per Protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 58 (89.66%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    58
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Neuropathy peripheral
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    38 / 58 (65.52%)
         occurrences all number
    58
    Neutropenia
         subjects affected / exposed
    22 / 58 (37.93%)
         occurrences all number
    58
    Thrombocytopenia
         subjects affected / exposed
    21 / 58 (36.21%)
         occurrences all number
    58
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    58
    Oedema
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    58
    Fatigue
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    58
    Asthenia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Gastrointestinal disorders
    Pyrexia
         subjects affected / exposed
    19 / 58 (32.76%)
         occurrences all number
    58
    Nausea
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    58
    Diarrhoea
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    58
    Vomiting
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    58
    Constipation
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    58
    Dyspnoea
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Rash
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Pruritus
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58
    Psychiatric disorders
    Depression
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Insomnia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Anxiety
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58
    Agitation
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    58
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    58
    Pneumonia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    58
    Hypocalcaemia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    58

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2011
    Substantial Amendment n.1: It was necessary to update the informed consent, following the update of the Investigator's Brochure of the drug Carfilzomib. Furthermore, the consent in the paragraph "Appendix on the protection of confidentiality" has been corrected and the paragraph relating to insurance has been updated.
    12 Feb 2018
    Substantial Amendment n.2: The Amendment was necessary to update the contacts of the Sponsor and the Principal Investigator of the study, as well as update the criteria for evaluating the disease response. With this amendment, the new documents relating to the drug Carfilzomib are transmitted, as it will be imported, labelled, packaged, released and distributed directly by Amgen Europe B.V., in Breda, and no longer by Fisher. Following this transition, the labels for Carfilzomib were updated. The side effects of Carfilzomib and the appendix on the protection of confidentiality have been updated on the Information Sheet and Informed Consent Form.
    11 Feb 2019
    Substantial Amendment n.3: The Amendment was necessary to update the following aspects: • Update on the side effects of the drug Carfilzomib on the Informed Consent • Privacy update according to new EU Regulation 2016/679
    16 Sep 2019
    Substantial Amendment n.4: The Amendment was necessary to update the side effects of the drug Carfilzomib on the Informed Consent
    10 Feb 2020
    Substantial Amendment n.5: The Amendment was necessary to update the side effects of the drug Carfilzomib on the Informed Consent
    30 Apr 2021
    Substantial Amendment n.6: The request for a substantial amendment concerns the change of the promoter of the study from HOVON Foundation to STICHTING EUROPEAN MYELOMA NETWORK (EMN) and the updating of the side effects of the drug Carfilzomib, based on what is reported in the Investigator's Brochure v.20.0 and v .20.1. The labels of the drug carfilzomib have been updated in order to meet the requirements of the cytotoxicity regulation. This review was made to align with the EMA/CHMP request to review the information on the marketed product. The risk classification for the drug carfilzomib did not change with the introduction of the cytotoxicity statement. There has been no new toxicity data or regulations since the drug Kyprolis gained approval. Furthermore, the requirements for handling and destroying the drug have not changed, so such changes will not have a significant impact on the safety or physical or mental integrity of clinical trial participants, or on the conduct or management of the trial.

    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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