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    Clinical Trial Results:
    BENDAMUSTINE, LENALIDOMIDE AND RITUXIMAB (R2-B) COMBINATION AS A SECOND-LINE THERAPY FOR FIRST RELAPSED-REFRACTORY MANTLE CELL LYMPHOMAS: A PHASE II STUDY

    Summary
    EudraCT number
    		 2011-005461-21
    Trial protocol
    		 IT  
    Global end of trial date
    02 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FILR2-B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01737177
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fondazione Italiana Linfomi (FIL) ONLUS
    Sponsor organisation address
    Piazza Turati 5, Alessandria, Italy,
    Public contact
    Segreteria, Fondazione Italiana Linfomi Onlus, +39 0131/033151, segreteriadirezione@filinf.it
    Scientific contact
    Segreteria, Fondazione Italiana Linfomi Onlus, +39 0131/033151, segreteriadirezione@filinf.it
    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 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To explore the antitumor activity of the association of R2-B in terms of complete response (CR) in patients with relapsed/refractory MCL to a first line of therapy. 2. To evaluate the efficacy of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding (CR or PR) to the induction, in terms of progression free survival (maPFS).
    Protection of trial subjects
    INDUCTION PHASE Lenalidomide dose modification according to hematological and extrahematological toxicity is allowed. Patients who can not tolerate the dose of 5 mg daily will prosecute the induction phase only with Rituximab and Bendamustine. If Lenalidomide dosing was halted during the previous cycle and was restarted with a one-level dose reduction without requiring an interruption for the remainder of the cycle, then that reduced dose level will be initiated on day 1 of the new cycle. There will be no more than one dose reduction from one cycle to the next. No dose (re-)escalation is permitted at any time. Those patients for whom Lenalidomide dose reduction is not sufficient and require also a reduction in the dose of Bendamustine, they will interrupt treatment, they will be considered failure and they will be treated according to the single centre policy. Bendamustine dose reduction is not allowed. Rituximab dose reduction is not planned. CONSOLIDATION PHASE Lenalidomide dose modification according to hematological and extrahematological toxicity is allowed. The minimum dose permitted is 5 mg daily. Patients who can not tolerate this dose will interrupt treatment. If Lenalidomide dosing was halted during the previous cycle and was restarted with a one-level dose reduction without requiring an interruption for the remainder of the cycle, then that reduced dose level will be initiated on day 1 of the new cycle. There will be no more than one dose reduction from one cycle to the next. No dose (re-)escalation is permitted at any time. Rituximab dose reduction is not planned. MAINTENANCE PHASE Permitted lenalidomide dose modifications during the maintenance phase are similar to those in the consolidation phase.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2012
    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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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
    30
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between July 2012 and June 2013, 42 patients were enrolled in Italian centers.

    Pre-assignment
    Screening details
    		 Patients with MCL relapsed or refractory after a first line of chemotherapy. All patients must satisfy all the inclusion criteria and none of exclusion criteria.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single arm
    Arm description
    		 R2-B treatment will be repeated for two cycles every 28 days, then patients will be evaluated for response; in case of CR, PR or SD, they will prosecute treatment for further two cycles. Patients after the end of the induction phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR and PR at the end of the induction phase, will continue therapy with a consolidation phase, that includes combination therapy with Lenalidomide and Rituximab (R2) every 28 days for 2 cycles. Patients after the end of the consolidation phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR or PR at the end of the consolidation treatment will continue to a maintenance phase with Lenalidomide until disease progression or unacceptable toxicity up to 18 months, with 28-days cycles
    Arm type
    		 Single arm study

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    INDUCTION PHASE (COURSE 1-4) Bendamustine: 70 mg/m2 on day 2 and 3 every 28

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    INDUCTION PHASE (COURSE 1-4) Lenalidomide: 10 mg/daily on day 1 to 14 of a 28 days course CONSOLIDATION PHASE (courses 5-6) Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days course MAINTENANCE PHASE (courses 7-24) Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use, Infusion
    Dosage and administration details
    INDUCTION PHASE (COURSE 1-4) Rituximab: 375 mg/m2 on day 1 every 28 days; only for the first cycle in the induction phase will start on day 8 CONSOLIDATION PHASE (courses 5-6) Rituximab: 375 mg/m2 on day 1 every 28 days

    Number of subjects in period 1
    		Single arm
    Started
    42
    Completed
    15
    Not completed
    27
         Adverse Event
    8
         Other
    2
         Progression
    16
         SD after induction
    1

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 42 42
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 30 30
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 70 (64 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 31 31
    1st line Therapy
    Units: Subjects
        R-CHOP o R-CHOP like
    		 27 27
        Regimen containing ARA-C
    		 3 3
        Regimen containing Fludarabine
    		 2 2
        ASCT
    		 10 10
    Clinical Response to 1st line therapy
    Units: Subjects
        CR
    		 30 30
        PR
    		 8 8
        SD
    		 2 2
        PD
    		 2 2
    Histology
    Units: Subjects
        MCL Classic
    		 41 41
        MCL Blastoid
    		 1 1
    B Symptomes
    Units: Subjects
        Yes
    		 6 6
        No
    		 36 36
    ECOG Performance status
    Units: Subjects
        ECOG 0
    		 25 25
        ECOG 1
    		 15 15
        ECOG 2
    		 2 2
    Stage
    Units: Subjects
        Stage I
    		 1 1
        Stage II
    		 2 2
        Stage III
    		 7 7
        Stage IV
    		 32 32
    Bone Envolvment
    Units: Subjects
        Neg
    		 21 21
        Pos
    		 18 18
        Not Evaluable
    		 3 3
    Mediastinal syndrome
    Units: Subjects
        Yes
    		 1 1
        No
    		 41 41
    IPI
    Units: Subjects
        IPI 1
    		 4 4
        IPI 2
    		 18 18
        IPI 3
    		 18 18
        IPI 5
    		 2 2
    Ki67
    Units: Subjects
        <10
    		 1 1
        20-30
    		 6 6
        >30
    		 10 10
        Not recorded
    		 25 25
    Duration of response (months)
    Units: Subjects
        <12
    		 11 11
        12-24
    		 12 12
        >24
    		 14 14
        Not recorded
    		 5 5
    MIPI
    Units: Score
        median (inter-quartile range (Q1-Q3))
    		 4 (3 to 6) -

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 R2-B treatment will be repeated for two cycles every 28 days, then patients will be evaluated for response; in case of CR, PR or SD, they will prosecute treatment for further two cycles. Patients after the end of the induction phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR and PR at the end of the induction phase, will continue therapy with a consolidation phase, that includes combination therapy with Lenalidomide and Rituximab (R2) every 28 days for 2 cycles. Patients after the end of the consolidation phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR or PR at the end of the consolidation treatment will continue to a maintenance phase with Lenalidomide until disease progression or unacceptable toxicity up to 18 months, with 28-days cycles

    Subject analysis set title
    Subject analyzed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Between July 2012 and June 2013, 42 patients were enrolled in Italian centers

    Primary: CR proportion after Induction/Consolidation phase

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    End point title
    		 CR proportion after Induction/Consolidation phase
    End point description
    Proportion of CR according to the Cheson2007 response criteria
    End point type
    Primary
    End point timeframe
    After Induction/Consolidation phase. At the end of the consolidation phase (6 months)
    End point values
    		 Single arm Subject analyzed
    Number of subjects analysed
    42
    42
    Units: Number of patients
        CR
    23
    23
    Statistical analysis title
    		 CR proportion after Induction/Consolidation phase
    Comparison groups
    Single arm v Subject analyzed
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Frequency percent (%)
    Point estimate
    55
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 41
         upper limit
    		 -

    Primary: Maintenance Progression Free Survival (maPFS)

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    End point title
    		 Maintenance Progression Free Survival (maPFS)
    End point description
    The maPFS in the subset of patients with CR or PR, receiving the maintenance regimen. maPFS in the maintenance cohort will be defined as the time between the date of CR/PR and the date of disease progression or death from any cause. Patients without events will be censored at the last follow up visit
    End point type
    Primary
    End point timeframe
    Up to 36 months
    End point values
    		 Single arm Subject analyzed
    Number of subjects analysed
    42
    42
    Units: Probability
        number (not applicable)
    60.3
    60.3
    Statistical analysis title
    		 maPFS for CR/PR patients after consolidation
    Statistical analysis description
    Time-to-event variables were analysed using the Kaplan-Meier method.
    Comparison groups
    Single arm v Subject analyzed
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan Meier estimates
    Point estimate
    60.3
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 43.3
         upper limit
    		 -

    Secondary: ORR after Induction/Consolidation phase

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    End point title
    		 ORR after Induction/Consolidation phase
    End point description
    Overall response rate (CR+PR) will be assessed at the end of the consolidation treatment
    End point type
    Secondary
    End point timeframe
    After Induction/Consolidation phase
    End point values
    		 Single arm Subject analyzed
    Number of subjects analysed
    42
    42
    Units: number of patients
        CR/PR
    33
    33
    Statistical analysis title
    		 Overall Response Rate (ORR)
    Comparison groups
    Single arm v Subject analyzed
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Frequency percent (%)
    Point estimate
    79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 63
         upper limit
    		 90

    Secondary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    Progression Free Survival (PFS) in all patients will be defined as the time between the date of enrolment and the date of recurrence/disease progression or death from any cause. Patients without events will be censored at the last follow up visit.
    End point type
    Secondary
    End point timeframe
    2-years
    End point values
    		 Single arm Subject analyzed
    Number of subjects analysed
    42
    42
    Units: 2-year probability
        number (confidence interval 95%)
    47.7 (27.7 to 57.0)
    47.7 (27.7 to 57.0)
    Statistical analysis title
    		 Progression Free Survival (PFS)
    Statistical analysis description
    Time-to-event variables were analysed using the Kaplan-Meier method.
    Comparison groups
    Single arm v Subject analyzed
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 2- years PFS
    Point estimate
    47.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.7
         upper limit
    		 57

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall Survival (OS) will be defined as the time between the date of enrollement (or the date of the end of consolidation for the maintenance cohort) and the date of death from any cause. Patients alive at the end of follow-up will be censored at the last follow up visit.
    End point type
    Secondary
    End point timeframe
    2-year
    End point values
    		 Single arm Subject analyzed
    Number of subjects analysed
    42
    42
    Units: 2-year probability
        number (confidence interval 95%)
    66.7 (50.3 to 78.7)
    66.7 (50.3 to 78.7)
    Statistical analysis title
    		 Overall Survival (OS)
    Statistical analysis description
    Time-to-event variables were analysed using the Kaplan-Meier method.
    Comparison groups
    Single arm v Subject analyzed
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Kaplan Meier estimates
    Point estimate
    66.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.3
         upper limit
    		 78.7

    Secondary: Safety evaluation induction

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    End point title
    		 Safety evaluation induction
    End point description
    Any grade III or higher toxicities will be recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (October 1, 2009).
    End point type
    Secondary
    End point timeframe
    After the first induction dose
    End point values
    		 Single arm
    Number of subjects analysed
    42
    Units: Subject
        Neutropenia
    30
        Thrombocytopenia
    6
        Febrile neutropenia
    4
        Anemia
    2
        Nephrotoxicity
    2
        Infections
    1
        Pulmonary toxicity
    3
        Cardiotoxicity
    1
        Urticaria
    1
        Syncope
    1
        Liver toxicity
    1
        Ipomagnesemia
    1
        Tumor lysis syndrome
    1
        GI toxicity
    0
        Neurotoxicity
    1
        Edema
    0
        Fatigue
    0
    No statistical analyses for this end point

    Secondary: Safety evaluation Maintenance

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    End point title
    		 Safety evaluation Maintenance
    End point description
    Any grade III or higher toxicities will be recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (October 1, 2009).
    End point type
    Secondary
    End point timeframe
    During maintenance therapy
    End point values
    		 Single arm
    Number of subjects analysed
    28
    Units: Subject
        Neutropenia
    20
        Thrombocytopenia
    2
        Febrile neutropenia
    2
        Anemia
    1
        Nephrotoxicity
    0
        Infections
    2
        Pulmonary toxicity
    0
        Cardiotoxicity
    0
        Urticaria
    0
        Syncope
    0
        Liver toxicity
    0
        Ipomagnesemia
    0
        Tumor lysis syndrome
    0
        GI toxicity
    1
        Neurotoxicity
    1
        Edema
    1
        Fatigue
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first induction dose or at any time during maintenance therapy (24 months).
    Adverse event reporting additional description
    Any grade III or higher toxicities will be recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (October 1, 2009).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 R2-B treatment will be repeated for two cycles every 28 days, then patients will be evaluated for response; in case of CR, PR or SD, they will prosecute treatment for further two cycles. Patients after the end of the induction phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR and PR at the end of the induction phase, will continue therapy with a consolidation phase, that includes combination therapy with Lenalidomide and Rituximab (R2) every 28 days for 2 cycles. Patients after the end of the consolidation phase who achieve less than PR will be treated according to best clinical practice but they will be included in the intention-to-treat population. Patients in CR or PR at the end of the consolidation treatment will continue to a maintenance phase with Lenalidomide until disease progression or unacceptable toxicity up to 18 months, with 28-days cycles

    Serious adverse events
    		 Single arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 42 (50.00%)
         number of deaths (all causes)
    14
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oncologic complication
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung cancer
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycoses fungoides
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Syncope
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuropathy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
         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
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Angioedema
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parenchymal lung disorders NEC
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 42 (2.38%)
         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 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 42 (92.86%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor lysis syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cardiac disorders
    Cardiotoxicity
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    32 / 42 (76.19%)
         occurrences all number
    132
    Thrombocytopenia
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    12
    Febrile neutropenia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    7
    Anaemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gastrointestinal disorders
    GI toxicity
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary toxicity
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Hepatobiliary disorders
    Liver toxicity
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Renal and urinary disorders
    Nephrotoxicity
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Infections and infestations
    Infections
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hypomagnesemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2013
    1) Modification related to dose reduction of lenalidomide in patients with moderate renal insufficiency 2) Correction of refusals to adapt the correspondence between the text of the protocol and the appendices 3) Introduction to the side study (Cereblon evaluation) 4) Addendum to the information sheet / informed consent following the introduction of the side study (Cereblon evaluation) 5) The updated IB is sent.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28082342
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