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    Clinical Trial Results:
    A phase II open label, non comparative, non randomized study for the assessment of the efficacy and safety of lenalidomide + adriamycine and low dose dexamethasone combination (RAD) in newly diagnosed, symptomatic multiple myeloma patients who are eligible for high dose therapy and autologous stem cell transplantation.

    Summary
    EudraCT number
    		 2011-001499-20
    Trial protocol
    		 GR  
    Global end of trial date
    26 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2022
    First version publication date
    27 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RV-MM-GMSG-392
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02471820
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meletios-Athanasios Dimopoulos
    Sponsor organisation address
    80 Vas. Sofias Ave & Lourou Str, Athens, Greece, 11528
    Public contact
    Meletios-Athanasios Dimopoulos, Meletios-Athanasios Dimopoulos, 0030 2103381541, mdimop@med.uoa.gr
    Scientific contact
    Meletios-Athanasios Dimopoulos, Meletios-Athanasios Dimopoulos, 0030 2103381541, mdimop@med.uoa.gr
    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
    28 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the overall response rate to lenalidomide in combination with adriamycin and low dose of dexamethasone (RAD regiment) in newly diagnosed patients with symptomatic MM eligible for high dose therapy and ASCT.
    Protection of trial subjects
    55% of the patients received prophylactic granulocyte colony stimulating factor during the treatment course. All of the efficacy and safety assessments were standard i.e. widely used and generally recognized as reliable, accurate and relevant (able to discriminate between effective and ineffective agents).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Nov 2014
    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
    Greece: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    43
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period was from November 2014 to February 2016. Recruitment took place in 3 sites in Greece.

    Pre-assignment
    Screening details
    		 Newly diagnosed patients with symptomatic MM, according to the criteria of the IMWG who were candidates for ΑSCT in good performance and hematological status were deemed eligible for inclusion in the study. Patients not fulfilling the above-mentioned criteria or with serious comorbidities were excluded.

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

    Arms
    Arm title
    		 1st Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide was administered per os at a dose of 25 mg daily, on days 1 to 21 of a 28-day cycle for 4 cycles.

    Investigational medicinal product name
    Dexamethasοne
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone was administered per os at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles.

    Investigational medicinal product name
    Doxorubicin/adriamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Doxorubicin/adriamycin was administered as intravenous bolus infusion at a dose of 9 mg/m², on days 1-4 of a 28-day cycle for 4 cycles.

    Number of subjects in period 1
    		1st Arm
    Started
    45
    Completed
    40
    Not completed
    5
         Toxicity
    3
         Lost to follow-up
    2

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 45 45
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 43 43
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    1st Arm
    Reporting group description
    		 -

    Subject analysis set title
    Baseline control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline measurements used as self control for comparison with RAD treatment after 4 cycles. In addition to study subjects, 30 healthy individuals (18 males and 12 females) were also tested for markers of bone remodeling and angiogenic cytokines and served as controls.

    Subject analysis set title
    After RAD x 4
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients that have received 4 cycles of RAD treatment.

    Primary: Overall Response Rate

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    End point title
    		 Overall Response Rate [1]
    End point description
    Overall Response Rate was 66.7%.
    End point type
    Primary
    End point timeframe
    End of study.
    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 statistical analysis was performed for this outcome measure.
    End point values
    		 1st Arm
    Number of subjects analysed
    45
    Units: Patients
        Complete Response
    1
        Very Good Partial Response
    8
        Partial Response
    21
    Attachments
    		 Untitled (Filename: Supplemental Figure 2.tiff)
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS) and Time-to Progression (TTP)

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    End point title
    		 Progression-free survival (PFS) and Time-to Progression (TTP)
    End point description
    Median PFS and TTP not reached
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 1st Arm
    Number of subjects analysed
    45
    Units: percent
    number (not applicable)
        1-year PFS and TTP probability
    88.6
        2-year PFS and TTP probability
    60
    Attachments
    		 Untitled (Filename: Figure 1.tiff)
    No statistical analyses for this end point

    Secondary: Grade 3 or 4 adverse events

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    End point title
    		 Grade 3 or 4 adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 1st Arm
    Number of subjects analysed
    45
    Units: Patients
        Anemia
    4
        Neutropenia
    3
        Febrile respiratory infection
    2
        Febrile neutropenia
    1
        Respiratory infection
    1
        Hypocalcemia
    1
        Acute renal failure
    1
        Pulmonary embolism
    1
        Lumbar pain
    1
        Pathological fracture
    1
        Leukopenia
    1
    No statistical analyses for this end point

    Other pre-specified: C-terminal cross-linking telopeptide of collagen type I levels

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    End point title
    		 C-terminal cross-linking telopeptide of collagen type I levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: ng/ml
        arithmetic mean (standard deviation)
    0.74 ± 0.30
    0.54 ± 0.14
    Attachments
    		 Untitled (Filename: CTX.png)
    Statistical analysis title
    		 CTX analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.03
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Versus baseline.

    Other pre-specified: Tartrate-resistant acid phosphatase isoform 5b levels

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    End point title
    		 Tartrate-resistant acid phosphatase isoform 5b levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: U/L
        arithmetic mean (standard deviation)
    3.42 ± 1.28
    1.25 ± 1.10
    Attachments
    		 Untitled (Filename: TRACP.png)
    Statistical analysis title
    		 TRACP-5b analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - Versus baseline.

    Other pre-specified: Bone-specific alkaline phosphatase levels

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    End point title
    		 Bone-specific alkaline phosphatase levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: μg/L
        arithmetic mean (standard deviation)
    11.5 ± 5.1
    15.3 ± 6.7
    Attachments
    		 Untitled (Filename: bALP.png)
    Statistical analysis title
    		 bALP analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.036
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - Versus baseline.

    Other pre-specified: Procollagen type 1 amino-terminal propeptide levels

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    End point title
    		 Procollagen type 1 amino-terminal propeptide levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: mg/L
        arithmetic mean (standard deviation)
    45 ± 15
    110 ± 57
    Attachments
    		 Untitled (Filename: PINP.png)
    Statistical analysis title
    		 P1NP analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - Versus baseline.

    Other pre-specified: Angiogenin levels

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    End point title
    		 Angiogenin levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: ng/mL
        arithmetic mean (standard deviation)
    420 ± 120
    250 ± 110
    Attachments
    		 Untitled (Filename: Ang.png)
    Statistical analysis title
    		 Ang analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - Versus baseline.

    Other pre-specified: Vascular endothelial growth factor levels

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    End point title
    		 Vascular endothelial growth factor levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: pg/mL
        arithmetic mean (standard deviation)
    260 ± 97
    108 ± 66
    Attachments
    		 Untitled (Filename: VEGF.png)
    Statistical analysis title
    		 VEGFanalysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [7] - Versus baseline.

    Other pre-specified: Fibroblast growth factor-basic levels

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    End point title
    		 Fibroblast growth factor-basic levels
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: pg/mL
        arithmetic mean (standard deviation)
    1.23 ± 0.42
    0.32 ± 0.18
    Attachments
    		 Untitled (Filename: bFGF.png)
    Statistical analysis title
    		 bFGF analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - Versus baseline.

    Other pre-specified: Angiopoietin-1 to angiopoietin-2 ratio

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    End point title
    		 Angiopoietin-1 to angiopoietin-2 ratio
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 Baseline control After RAD x 4
    Number of subjects analysed
    45
    40
    Units: Ratio
        arithmetic mean (standard deviation)
    13.3 ± 10.9
    18.8 ± 12.6
    Attachments
    		 Untitled (Filename: Ang1-Ang2.png)
    Statistical analysis title
    		 Ang-1/Ang-2 analysis
    Comparison groups
    Baseline control v After RAD x 4
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.022
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [9] - Versus baseline.

    Other pre-specified: Stem cell collection post-RAD induction

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    End point title
    		 Stem cell collection post-RAD induction
    End point description
    End point type
    Other pre-specified
    End point timeframe
    End of study
    End point values
    		 1st Arm
    Number of subjects analysed
    45
    Units: Patients
    number (not applicable)
        Adequate stem cell collection
    40
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    1st Arm
    Reporting group description
    		 -

    Serious adverse events
    		 1st Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 45 (22.22%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Fainting
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dysautonomia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Septicemia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Liver disease
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Maculopapular rash
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Deterioration of renal function
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Febrile neutropenia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile respiratory tract infection
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    CMV Reactivation
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Metabolism and nutrition disorders
    Transaminases abnormal
         subjects affected / exposed
    1 / 45 (2.22%)
         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
    		 1st Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 45 (68.89%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    18 / 45 (40.00%)
         occurrences all number
    36
    Thrombocytopenia
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    7
    Leukopenia
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    7
    Neutropenia
         subjects affected / exposed
    8 / 45 (17.78%)
         occurrences all number
    20
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    23 / 45 (51.11%)
         occurrences all number
    30
    Musculoskeletal and connective tissue disorders
    Fatigue
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    8
    Bone pain
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    2
    Lumbar pain
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Infections and infestations
    Fever
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Respiratory infection
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyponatremia
         subjects affected / exposed
    6 / 45 (13.33%)
         occurrences all number
    6
    Hypokalemia
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Elevated GGT
         subjects affected / exposed
    7 / 45 (15.56%)
         occurrences all number
    11
    Elevated AST levels
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Hypocalcemia
         subjects affected / exposed
    8 / 45 (17.78%)
         occurrences all number
    12
    Hypercalcemia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Ypercholirethryaimia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Ηyponatremia
         subjects affected / exposed
    6 / 45 (13.33%)
         occurrences all number
    8
    Elevated ACT levels
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Elevated ALT levels
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Elevated ALP levels
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2014
    The main reason behind the substantial protocol amendment was the implementation of further measures for pregnancy prevention plans.

    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
    For support, Contact us.
    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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