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    Clinical Trial Results:
    A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Effect of VELCADE® on Myeloma related Bone Disease.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2008-004264-39
    Trial protocol
    		 CZ   DK   AT   GB   SE   DE   GR  
    Global end of trial date
    30 Apr 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    26866138-MMY-2060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01286077
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340, Beerse,, Belgium,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    30 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the effect of bortezomib on myeloma related bone disease by analyzing bone mineral density (BMD).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 10
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Turkey: 48
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    104
    EEA total number of subjects
    56
    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)
    91
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was planned to enroll about 120 participants in order to obtain at least 100 participants eligible for evaluation (i.e, about 50 in each group). Overall, 115 participants were enrolled of which 106 were randomized with 52 participants allocated to the bortezomib and 54 participants to the observational arm.

    Pre-assignment
    Screening details
    		 At Screening, demographic parameters comprised gender, age, body height and weight, body surface area (BSA), body mass index (BMI), and Karnofsky performance status (KPS). Medical history was recorded including prior cardiac and neurological details with a special focus on multiple myeloma (MM).

    Period 1
    Period 1 title
    Treatment/Observation Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bortezomib
    Arm description
    		 Bortezomib (Velcade) Arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each cycle will consist of 5 weeks treatment. participants in the treatment group will receive: Velcade® 1.6 milligram per square meter mg/m2 as an intravenous bolus injection on Days 1, 8, 15, and 22 of each cycle followed by a 13-day rest period (Days 23 to 35) Cycle will be repeated on Day 36. Participants in the treatment group will receive up to 4 treatment cycles, unless they experience either unacceptable toxicity or if the participants requests to withdraw from the study.

    Arm title
    		 Observation
    Arm description
    		 Observation Arm
    Arm type
    		 other

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Bortezomib Observation
    Started
    51
    53
    Completed
    41
    46
    Not completed
    10
    7
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    -
    2
         refill medication not received in time
    1
    -
         The subject starts with alternative MMY
    -
    3
         Death
    1
    -
         Intercurrent illness
    1
    -
         Non-compliance
    1
    -
         Progression of disease
    -
    1
         Patient's decision to stop treatment
    3
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bortezomib
    Reporting group description
    		 Bortezomib (Velcade) Arm

    Reporting group title
    Observation
    Reporting group description
    		 Observation Arm

    Reporting group values
    		 Bortezomib Observation Total
    Number of subjects
    		 51 53 104
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 45 46 91
        From 65 to 84 years
    		 6 7 13
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.7 ± 8.3 54.7 ± 9.13 -
    Title for Gender
    Units: subjects
        Female
    		 18 22 40
        Male
    		 33 31 64

    End points

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    End points reporting groups
    Reporting group title
    Bortezomib
    Reporting group description
    		 Bortezomib (Velcade) Arm

    Reporting group title
    Observation
    Reporting group description
    		 Observation Arm

    Subject analysis set title
    Intent-to-treat Set (ITTS)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITTS included all participants who were randomized and received at least one dose of study medication (bortezomib group) or had at least one post-baseline assessment in the observation arm.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all participants of the ITTS who have a baseline value and at least one post-baseline assessment for BMD.

    Primary: Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of treatment (EOT)

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    End point title
    		 Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of treatment (EOT)
    End point description
    Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit
    End point type
    Primary
    End point timeframe
    At screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier.
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    38 [1]
    39 [2]
    Units: Gram per milli meter square ([g/mm2)
        arithmetic mean (standard deviation)
    0.0214 ± 0.0306
    0.0167 ± 0.0301
    Notes
    [1] - Intension- to-treat.
    [2] - Intension- to-treat.
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Bortezomib v Observation
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5287
    Method
    		 ANCOVA
    Confidence interval

    Primary: Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment

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    End point title
    		 Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment
    End point description
    Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit
    End point type
    Primary
    End point timeframe
    At screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    43 [3]
    45 [4]
    Units: Gram per millimeter square [g/mm2]
    arithmetic mean (standard deviation)
        Femur neck
    0.0053 ± 0.0221
    0.0044 ± 0.0299
        Femur total
    0.0071 ± 0.0151
    0.0138 ± 0.0288
    Notes
    [3] - Intension to treat.
    [4] - Intension to treat.
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Bortezomib v Observation
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9019
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
    End point type
    Secondary
    End point timeframe
    Until 18 months after end of treatment (approximately 24 months after randomization.
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [5]
    47 [6]
    Units: Months
    arithmetic mean (standard error)
        PFS from start of first MM treatment
    39.56 ± 2.02
    31.66 ± 1.81
        PFS from randomization
    31.35 ± 2.41
    16.72 ± 1.2
    Notes
    [5] - FAS
    [6] - FAS
    No statistical analyses for this end point

    Secondary: Percent change From Baseline in Biochemical Bone Markers

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    End point title
    		 Percent change From Baseline in Biochemical Bone Markers
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 of cycle 3, EOT visit (24 weeks after randomization or until start of alternative MMY therapy, if earlier) and 4, 6, 12 and 18 months after EOT
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [7]
    47 [8]
    Units: Percent Change
    arithmetic mean (standard deviation)
        LOCF EOT(n=43,44)
    -3.1 ± 38.8
    -10.52 ± 27.45
        LOCF FU(n =42,40)
    3.44 ± 47.35
    -15.25 ± 31.86
    Notes
    [7] - FAS
    [8] - FAS
    No statistical analyses for this end point

    Secondary: Number of Participants with Skeletal related Events

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    End point title
    		 Number of Participants with Skeletal related Events
    End point description
    Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer.
    End point type
    Secondary
    End point timeframe
    At each visit from screening to 18 months after EOT (approximately 24 months after randomization)
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [9]
    47 [10]
    Units: Participants
        number (not applicable)
    0
    0
    Notes
    [9] - FAS
    [10] - FAS
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in BMD Over Time

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    End point title
    		 Percent Change From Baseline in BMD Over Time
    End point description
    End point type
    Secondary
    End point timeframe
    Screening EOT and Follow up
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [11]
    47
    Units: percent change
    arithmetic mean (standard deviation)
        Screening (n= 38)
    0.9898 ± 0.173
    1.0181 ± 0.208
        Percent Change at LOCF EOT (n=38)
    1.0111 ± 0.178
    1.0347 ± 0.2053
        Percent Change at LOCF FU (n=38)
    1.0407 ± 0.1927
    1.0697 ± 0.1964
    Notes
    [11] - FAS
    No statistical analyses for this end point

    Secondary: Karnofsky Performance Status

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    End point title
    		 Karnofsky Performance Status
    End point description
    End point type
    Secondary
    End point timeframe
    At screening, Day 1 of Cycle 2, 3, and 4 or Day 36, 71 and 106 for observation arm, at EOT Visit, and and 4, 6, 12 and 18 months after EOT or start of alternative MMY therapy
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [12]
    47 [13]
    Units: percent change
    arithmetic mean (standard deviation)
        Screening
    92.4 ± 9.2
    91.9 ± 9.7
        LOCF EOT
    91.7 ± 9
    91.7 ± 7.3
        LOCF FU
    92.4 ± 10.2
    92.3 ± 7
    Notes
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    until 18 months after EOT (approximately 24 months after randomization)
    End point values
    		 Bortezomib Observation
    Number of subjects analysed
    46 [14]
    47 [15]
    Units: Months
        arithmetic mean (standard error)
    49.9 ± 1.48
    47.26 ± 1.26
    Notes
    [14] - FAS
    [15] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Observation
    Reporting group description
    		 Observation Arm

    Reporting group title
    Bortezomib
    Reporting group description
    		 Bortezomib (Velcade) Arm

    Serious adverse events
    		 Observation Bortezomib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 53 (5.66%)
    6 / 51 (11.76%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic Neoplasm
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (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 / 53 (1.89%)
    0 / 51 (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 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute Hepatic Failure
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (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
    1 / 53 (1.89%)
    0 / 51 (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
    Device Related Infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    		 Observation Bortezomib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 53 (66.04%)
    47 / 51 (92.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 51 (7.84%)
         occurrences all number
    1
    5
    Neuralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 51 (9.80%)
         occurrences all number
    0
    7
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    2 / 53 (3.77%)
    10 / 51 (19.61%)
         occurrences all number
    3
    21
    Paraesthesia
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 51 (7.84%)
         occurrences all number
    3
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Leukopenia
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    5
    Neutropenia
         subjects affected / exposed
    1 / 53 (1.89%)
    6 / 51 (11.76%)
         occurrences all number
    1
    11
    Thrombocytopenia
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 51 (9.80%)
         occurrences all number
    0
    9
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 53 (3.77%)
    8 / 51 (15.69%)
         occurrences all number
    2
    9
    Fatigue
         subjects affected / exposed
    1 / 53 (1.89%)
    7 / 51 (13.73%)
         occurrences all number
    1
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    10
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Dry Mouth
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Diarrhoea
         subjects affected / exposed
    0 / 53 (0.00%)
    19 / 51 (37.25%)
         occurrences all number
    0
    58
    Dyspepsia
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Nausea
         subjects affected / exposed
    0 / 53 (0.00%)
    9 / 51 (17.65%)
         occurrences all number
    0
    17
    Vomiting
         subjects affected / exposed
    0 / 53 (0.00%)
    8 / 51 (15.69%)
         occurrences all number
    0
    19
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 51 (5.88%)
         occurrences all number
    5
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 53 (9.43%)
    1 / 51 (1.96%)
         occurrences all number
    5
    1
    Bone Pain
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 51 (5.88%)
         occurrences all number
    4
    4
    Back Pain
         subjects affected / exposed
    5 / 53 (9.43%)
    5 / 51 (9.80%)
         occurrences all number
    5
    6
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2
    Pain in Extremity
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 51 (7.84%)
         occurrences all number
    1
    5
    Infections and infestations
    Herpes Zoster
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 51 (7.84%)
         occurrences all number
    3
    4
    Influenza
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 51 (1.96%)
         occurrences all number
    4
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 53 (7.55%)
    6 / 51 (11.76%)
         occurrences all number
    4
    8
    Upper Respiratory Tract Infection
         subjects affected / exposed
    9 / 53 (16.98%)
    9 / 51 (17.65%)
         occurrences all number
    10
    16
    Metabolism and nutrition disorders
    Vitamin B12 Deficiency
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2010
    Amendment EU-3) was considered substantial and included the following changes: deletion of exclusion criterion referring to participants with oligosecretory or non-secretory MM and minor editorial changes. Rationale for deletion of the exclusion criterion was the consideration that participants enrolled had already achieved PR following first-line therapy. In addition, BMD can be monitored in participants with oligosecretory or non-secretory MM. Disease progression in such participants was to be monitored using a free light chains assay.

    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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