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    Clinical Trial Results:
    A PHASE II MULTI-CENTRE, RANDOMIZED, OPEN LABEL STUDY OF PROLONGED THERAPY WITH SUBCUTANEOUS BORTEZOMIB TWICE MONTHLY ASSOCIATED WITH DEXAMETHASONE, IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER SALVAGE WITH BORTEZOMIB-BASED THERAPY.

    Summary
    EudraCT number
    		 2013-000432-10
    Trial protocol
    		 IT  
    Global end of trial date
    11 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2023
    First version publication date
    04 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    26866138MMY2084
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01913730
    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, +39 0110243236, clinicaltrialoffice@emnitaly.org
    Scientific contact
    Clinical Trial Office, Fondazione EMN Italy Onlus, +39 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
    11 Oct 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of a prolonged treatment with bortezomib twice monthly s.c. in association with dexamethasone, after a salvage treatment containing bortezomib i.v. in relapsed and refractory multiple myeloma patients. - To assess the safety of prolonged treatment with bortezomib s.c.
    Protection of trial subjects
    The study will be conducted in accordance with ethical principles founded in the Declaration of Helsinki. The IRB/IEC will review all appropriate study documentation in order to safeguard the rights, safety and well-being of the patients. The study will only be conducted at sites where IRB/IEC approval has been obtained. The protocol, Investigator’s Brochure, informed consent, advertisements (if applicable), written information given to the patients (including diary cards), safety updates, annual progress reports, and any revisions to these documents will be provided to the IRB/IEC by the investigator
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2013
    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
    Italy: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    11
    From 65 to 84 years
    49
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a multicenter, randomized, non-comparative open label study designed to evaluate the efficacy and safety of treatment with bortezomib and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma 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
    Phase II (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm B
    Arm description
    		 Observation every 28 days
    Arm type
    		 Observation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Arm C
    Arm description
    		 Treatment at biochemical relapse. Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 6 VD cycles will be administered. Biochemical relapse is defined as an increase of 25% from the lowest response value in any of the following: serum M-component (absolute increase must be 0.5 g/dL), and/or urine M-component (absolute increase must be 200 mg/24 h).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velcade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At the occurrence of biochemical relapse 6 VD cycles will be administered: 1. Bortezomib (VELCADE) will be given as subcutaneous (s.c.) injection at the dose of 1.3 mg/m2 on days 1, 8, 15, 22. Each cycle will be repeated every 28 days.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At the occurrence of biochemical relapse 6 VD cycles will be administered: 2. Dexamethasone will be given orally at the dose of 40 mg weekly. Each cycle will be repeated every 28 days.

    Arm title
    		 Arm A
    Arm description
    		 VD Prolonged therapy 1. Bortezomib (VELCADE) will be given as subcutaneous (SC) injection at the dose of 1.3 mg/m2 on days 1, 15. Each cycle will be repeated every 28 days, until development of PD. 2. Dexamethasone will be given orally at the dose of 20 mg on days 1, 2, and 15, 16 of each cycle. Each cycle will be repeated every 28 days, until development of PD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velcade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At the occurrence of biochemical relapse 6 VD cycles will be administered: 1. Bortezomib (VELCADE) will be given as subcutaneous (s.c.) injection at the dose of 1.3 mg/m2 on days 1, 8, 15, 22. Each cycle will be repeated every 28 days.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At the occurrence of biochemical relapse 6 VD cycles will be administered: 2. Dexamethasone will be given orally at the dose of 40 mg weekly. Each cycle will be repeated every 28 days.

    Number of subjects in period 1
    		Arm B Arm C Arm A
    Started
    23
    24
    16
    Completed
    0
    0
    0
    Not completed
    23
    24
    16
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    2
    3
    3
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    -
    2
    3
         screening failure
    -
    1
    -
         Lack of efficacy
    21
    16
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm B
    Reporting group description
    		 Observation every 28 days

    Reporting group title
    Arm C
    Reporting group description
    		 Treatment at biochemical relapse. Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 6 VD cycles will be administered. Biochemical relapse is defined as an increase of 25% from the lowest response value in any of the following: serum M-component (absolute increase must be 0.5 g/dL), and/or urine M-component (absolute increase must be 200 mg/24 h).

    Reporting group title
    Arm A
    Reporting group description
    		 VD Prolonged therapy 1. Bortezomib (VELCADE) will be given as subcutaneous (SC) injection at the dose of 1.3 mg/m2 on days 1, 15. Each cycle will be repeated every 28 days, until development of PD. 2. Dexamethasone will be given orally at the dose of 20 mg on days 1, 2, and 15, 16 of each cycle. Each cycle will be repeated every 28 days, until development of PD.

    Reporting group values
    		 Arm B Arm C Arm A Total
    Number of subjects
    		 23 24 16 63
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 1 3 10
        From 65-84 years
    		 15 23 12 50
        85 years and over
    		 2 0 1 3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 68 (48 to 85) 73 (63 to 83) 72 (50 to 89) -
    Gender categorical
    Units: Subjects
        Female
    		 13 11 7 31
        Male
    		 10 13 9 32
    ISS Stage
    Units: Subjects
        ISS Stage I
    		 17 15 11 43
        ISS Stage II
    		 3 7 3 13
        ISS Stage III
    		 3 2 2 7
    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
    63
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    10
        From 65-84 years
    50
        85 years and over
    3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    71 (48 to 89)
    Gender categorical
    Units: Subjects
        Female
    31
        Male
    32
    ISS Stage
    Units: Subjects
        ISS Stage I
    43
        ISS Stage II
    13
        ISS Stage III
    7

    End points

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    End points reporting groups
    Reporting group title
    Arm B
    Reporting group description
    		 Observation every 28 days

    Reporting group title
    Arm C
    Reporting group description
    		 Treatment at biochemical relapse. Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 6 VD cycles will be administered. Biochemical relapse is defined as an increase of 25% from the lowest response value in any of the following: serum M-component (absolute increase must be 0.5 g/dL), and/or urine M-component (absolute increase must be 200 mg/24 h).

    Reporting group title
    Arm A
    Reporting group description
    		 VD Prolonged therapy 1. Bortezomib (VELCADE) will be given as subcutaneous (SC) injection at the dose of 1.3 mg/m2 on days 1, 15. Each cycle will be repeated every 28 days, until development of PD. 2. Dexamethasone will be given orally at the dose of 20 mg on days 1, 2, and 15, 16 of each cycle. Each cycle will be repeated every 28 days, until development of PD.

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

    Primary: TTP

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    End point title
    		 TTP
    End point description
    TTP will be measured in months from the date of enrolment to the date of first observation of disease progression, or deaths related to disease progression
    End point type
    Primary
    End point timeframe
    24 months
    End point values
    		 Arm B Arm C Arm A ITT
    Number of subjects analysed
    23
    24
    16
    63
    Units: month
        median (confidence interval 95%)
    5.6 (3.7 to 15.4)
    8.1 (4.8 to 19.4)
    18.2 (12.8 to 31.1)
    8.4 (6.1 to 17.2)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Arm B v Arm C v Arm A v ITT
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - No statistical analysis
    [2] - No statistical analysis

    Secondary: OS

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    End point title
    		 OS
    End point description
    OS is defined as the time between enrolment and death. Subject who die, regardless the cause of death, will be censored as an event
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Arm B Arm C Arm A ITT
    Number of subjects analysed
    23
    24
    16
    63
    Units: month
        median (confidence interval 95%)
    29.6 (24.03 to 62.7)
    31.7 (27.4 to 62.7)
    45.1 (39.3 to 62.7)
    39.3 (29.1 to 62.7)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Arm B v Arm C v Arm A v ITT
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [3] - No statistical analysis
    [4] - No statistical analysis

    Secondary: PFS

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    End point title
    		 PFS
    End point description
    PFS will be measured in months from the date of enrolment to the date of first observation of disease progression, or death to any cause as an event. Subjects who withdraw from the study will be considered censored at the time of the last complete disease assessment
    End point type
    Secondary
    End point timeframe
    24 monhts
    End point values
    		 Arm B Arm C Arm A ITT
    Number of subjects analysed
    23
    24
    16
    63
    Units: month
        median (confidence interval 95%)
    5.6 (3.7 to 15.4)
    8.2 (4.8 to 19.4)
    18.2 (12.8 to 31.1)
    8.4 (6 to 17.2)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Arm B v Arm C v Arm A v ITT
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [5] - No statistical analysis
    [6] - No statistical analysis

    Secondary: TNT

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    End point title
    		 TNT
    End point description
    TTP will be measured in months from the date of the beginning of the salvage treatment to the date of first observation of disease progression, or deaths related to disease progression
    End point type
    Secondary
    End point timeframe
    24 monts
    End point values
    		 Arm B Arm C Arm A ITT
    Number of subjects analysed
    23
    24
    16
    63
    Units: month
        median (confidence interval 95%)
    11 (6.9 to 26.7)
    21.5 (18.6 to 70.4)
    42.8 (22.7 to 50)
    21.5 (15.5 to 28)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Arm B v Arm C v Arm A v ITT
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0 [8]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [7] - No statistical analysis
    [8] - No statistical analysis

    Secondary: ORR Rate

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    End point title
    		 ORR Rate
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Arm B Arm C Arm A ITT
    Number of subjects analysed
    23
    24
    16
    63
    Units: Patients
        PR/VGPR/CR/sCR
    7
    14
    9
    30
        SD/PD/NE
    16
    10
    7
    33
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Arm B v Arm C v Arm A v ITT
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0 [10]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [9] - No statistical analysis
    [10] - No statistical analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    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
    6 / 62 (9.68%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Cardiac disorders
    Mitral valve disease
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 62 (1.61%)
         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
    42 / 62 (67.74%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    10 / 62 (16.13%)
         occurrences all number
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 62 (24.19%)
         occurrences all number
    15
    Neutropenia
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Thrombocytopenia
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Asthenia
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Oedema
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2013
    Substantial Amendment n.1: With this amendment a third maintenance arm was added, with subcutaneous Velcade and dexamethasone upon the occurrence of biochemical relapse (Arm C). It should be noted that a comparison will be made between the control arm Arm B (no maintenance) and the two experimental arms Arm A (prolonged VD) and Arm C to demonstrate the superiority of the experimental arms. This means that the control arm will be the same for both experimental arms, and the two experimental arms will not be compared to each other. This change led to an increase in the sample, therefore 216 patients will have to be enrolled.
    18 Mar 2014
    Substantial Amendment n.2: With this amendment, a change was made to the study design. More precisely, patients randomized to Arm C, upon the occurrence of biochemical relapse, will be treated with 6 cycles of treatment (Velcade and Dexamethasone). Velcade and Dexamethasone will be administered on days 1, 8, 15, 22. This treatment will be repeated at each biochemical relapse until the clinical relapse of the disease.
    10 Nov 2015
    Substantial Amendment n.3: Considering the experimental nature of the maintenance treatment, it was deemed appropriate to reduce the sample of patients to be subjected to the treatment in order to obtain a preliminary evaluation on a small number of patients. Furthermore, this preventive measure will allow us not to expose an excessive number of patients to a treatment that may be too toxic or ineffective. With this amendment, one of the primary objectives is to evaluate the efficacy and feasibility of maintenance treatment with bortezomib administered in combination with dexamethasone at biochemical relapse, after salvage treatment containing bortezomib. Therefore a comparison will be made between Arm B and Arm C. With this sample reduction, 46 patients will need to be enrolled (23 per arm).
    04 Apr 2017
    Substantial Amendment n.4: This amendment was necessary to update the contacts of the Sponsor and the Principal Investigator from the study, as well as update the criteria for evaluating the disease response. This amendment also transmits the instructions relating to monitoring the temperature of the drug bortezomib, provided by the company supplying the drug B&C, under the instructions of Janssen International. The participating centers will have to communicate any temperature excursion, verified during transport until delivery to each individual center. The side effects of the drug Velcade were also updated on the informed consent and those of Dexamethasone were added.
    20 Apr 2021
    Substantial Amendment n.5: 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 bortezomib, reported on the information sheet and informed consent form. Following this change of promoter, all study documents have been modified.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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