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    Clinical Trial Results:
    Rituximab plus lenalidomide or rituximab monotherapy for untreated patients with follicular lymphoma in need of therapy. A randomized, open-label, multicentre phase II trial.

    Summary
    EudraCT number
    		 2010-021253-39
    Trial protocol
    		 SE   DK   FI   IT  
    Global end of trial date
    26 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Sep 2024
    First version publication date
    29 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAKK35/10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01307605
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swiss Group for Clinical Cancer Research (SAKK)
    Sponsor organisation address
    Effingerstrasse 33, Bern, Switzerland, 3008
    Public contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer Research SAKK, +41 31389 91 91, sakkcc@sakk.ch
    Scientific contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer Research SAKK, +41 31389 91 91, sakkcc@sakk.ch
    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 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Main objective of the trial is to determine the activity of the combination of rituximab and lenalidomide given to untreated follicular lymphoma (FL) patients versus rituximab treatment and the safety of both therapy arms.
    Protection of trial subjects
    Protection of trial subjects was ensured by Safety Monitoring, i.e. assessment of adverse events, serious adverse events, adverse drug reactions, and the continous assessment of laboratory values and vital signs.
    Background therapy
    		 Not applicable.
    Evidence for comparator
    		 Rituximab in combination with chemotherapy has shown excellent activity as front-line therapy in patients with follicular lymphoma (FL), but it has not been shown to clearly impact overall survival (OS), whilst most combination regimens carry a significant toxicity. The results of the previous SAKK-trial [PMID: 14976046] and the Nordic-trial [PMID: 18203019] suggest that therapy with rituximab single agent is effective and well tolerated and offers to a subset of FL patients an opportunity to achieve long-term remission and prolonged failure-free survival.
    Actual start date of recruitment
    12 Apr 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 20
    Country: Number of subjects enrolled
    Sweden: 25
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    Switzerland: 73
    Worldwide total number of subjects
    154
    EEA total number of subjects
    81
    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)
    90
    From 65 to 84 years
    63
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 154 patients at 29 sites in Switzerland (17 sites, 73 patients), Denmark (1 site, 6 patients), Finland (1 site, 8 patients), Italy (2 sites, 22 patients), Norway (3 sites, 20 patients) and Sweden (5 sites, 25 patients) have been enrolled from April 2011 to October 2013.

    Pre-assignment
    Screening details
    		 Eligibility criteria of a patient were checked by the investigator. Once a patient fullfils all inclusion criteria and not any of the exclusion criteria, he/she was enrolled.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A - Rituximab Mono
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    MabThera®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab was administered for 8 infusions of 375mg/m2 at day 1 of weeks 1, 2, 3, 4, and again at day 1 of weeks 12, 13, 14 and 15.

    Arm title
    		 Arm B - Rituximab plus Lenalidomide
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    MabThera®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab was administered for 8 infusions of 375mg/m2 at day 1 of weeks 1, 2, 3, 4, and again at day 1 of weeks 12, 13, 14 and 15.

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide was to be administered daily p.o. starting 14 days before the first and stopping 14 days after the last rituximab infusion in addition to rituximab, which was to be given in the same scheme as for Arm A.

    Number of subjects in period 1
    		Arm A - Rituximab Mono Arm B - Rituximab plus Lenalidomide
    Started
    77
    77
    Completed
    76
    77
    Not completed
    1
    0
         No treatment received
    1
    -
    Period 2
    Period 2 title
    Treatment Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A - Rituximab Mono
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    MabThera®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab was administered for 8 infusions of 375mg/m2 at day 1 of weeks 1, 2, 3, 4, and again at day 1 of weeks 12, 13, 14 and 15.

    Arm title
    		 Arm B - Rituximab plus Lenalidomide
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    MabThera®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab was administered for 8 infusions of 375mg/m2 at day 1 of weeks 1, 2, 3, 4, and again at day 1 of weeks 12, 13, 14 and 15.

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide was to be administered daily p.o. starting 14 days before the first and stopping 14 days after the last rituximab infusion in addition to rituximab, which was to be given in the same scheme as for Arm A.

    Number of subjects in period 2
    		Arm A - Rituximab Mono Arm B - Rituximab plus Lenalidomide
    Started
    76
    77
    Completed
    55
    58
    Not completed
    21
    19
         Relapse
    1
    -
         Consent withdrawn by subject
    1
    -
         Other
    2
    3
         Stopped lenalidomide early due to toxicity
    -
    13
         Stable disease or progressing disease at week 10
    16
    3
         Unacceptabel toxicity
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A - Rituximab Mono
    Reporting group description
    		 -

    Reporting group title
    Arm B - Rituximab plus Lenalidomide
    Reporting group description
    		 -

    Reporting group values
    		 Arm A - Rituximab Mono Arm B - Rituximab plus Lenalidomide Total
    Number of subjects
    		 77 77 154
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 43 47 90
        From 65-84 years
    		 33 30 63
        85 years and over
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 40 42 82
        Male
    		 37 35 72

    End points

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    End points reporting groups
    Reporting group title
    Arm A - Rituximab Mono
    Reporting group description
    		 -

    Reporting group title
    Arm B - Rituximab plus Lenalidomide
    Reporting group description
    		 -
    Reporting group title
    Arm A - Rituximab Mono
    Reporting group description
    		 -

    Reporting group title
    Arm B - Rituximab plus Lenalidomide
    Reporting group description
    		 -

    Subject analysis set title
    Arm A - Rituximab | ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients were included in the ITT population.

    Subject analysis set title
    Arm B - Rituximab + Lenalidomide | ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients were included in the ITT population.

    Subject analysis set title
    Arm A - Rituximab | FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    One patient, randomized in arm A, did not start trial treatment and was excluded from the FAS. In addition, for one patient in arm A the diagnosis of FL grade 1, 2 or 3a was unconfirmed by the central pathology review. This patient wasalso excluded from the FAS.

    Subject analysis set title
    Arm B - Rituximab + Lenalidomide | FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Two patients in arm B did not start rituximab and for two additional patients in arm B the diagnosis of FL grade 1, 2 or 3a was unconfirmed by the central pathology review. These four patients were excluded from the FAS.

    Subject analysis set title
    Arm A - Rituximab | PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Ten patients in arm A did not fulfill the criteria defining the PP population and were excluded from the PPS.

    Subject analysis set title
    Arm B - Rituximab + Lenalidomide | PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Twenty patients in arm A did not fulfill the criteria defining the PP population and were excluded from the PPS.

    Primary: PE | Rate of complete remission (CR) at week 23 - ITT

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    End point title
    		 PE | Rate of complete remission (CR) at week 23 - ITT
    End point description
    A success was defined as any patient with a complete remission or CR unconfirmed at the second tumor assessment planned at week 23, regardless of the actual assessment date. Responses at week 23: Arm A: CR=9.1%; CRu=15.6%; PR=36.4%; SD=7.8%; PD=2.6%; not done=28.6% | Arm B: CR=18.2%; CRu=18.2%; PR=45.5%; SD=5.2%; PD=3.9%; not done=9.1%. CR: complete remission, CRu: unconfirmed CR; PR: partial response; SD: stable disease; PD: progressing disease
    End point type
    Primary
    End point timeframe
    At week 23
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: % patients with CR/CRu
        number (confidence interval 95%)
    24.7 (15.6 to 35.8)
    36.4 (25.7 to 48.1)
    Statistical analysis title
    		 Z-test
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0562
    Method
    		 Z-Test
    Confidence interval
    Notes
    [1] - One-sided Z-test with unpooled variance / significance level = 0.10

    Primary: PE | Rate of complete remission (CR) at week 23 - FAS

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    End point title
    		 PE | Rate of complete remission (CR) at week 23 - FAS
    End point description
    A success was defined as any patient with a complete remission or CR unconfirmed at the second tumor assessment planned at week 23, regardless of the actual assessment date. Responses at week 23: Arm A: CR=9.3%; CRu=16.0%; PR=37.3%; SD=8.0%; PD=2.7%; not done=26.7% | Arm B: CR=19.2%; CRu=19.2%; PR=47.9%; SD=5.5%; PD=4.1%; not done=4.1%. CR: complete remission, CRu: unconfirmed CR; PR: partial response; SD: stable disease; PD: progressing disease
    End point type
    Primary
    End point timeframe
    At week 23
    End point values
    		 Arm A - Rituximab | FAS Arm B - Rituximab + Lenalidomide | FAS
    Number of subjects analysed
    75
    73
    Units: % patients with CR/CRu
        number (confidence interval 95%)
    25.3 (16.0 to 36.7)
    38.4 (27.2 to 50.5)
    Statistical analysis title
    		 Z-test
    Comparison groups
    Arm A - Rituximab | FAS v Arm B - Rituximab + Lenalidomide | FAS
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0431 [2]
    Method
    		 Z-Test
    Confidence interval
    Notes
    [2] - One-sided Z-test with unpooled variance.

    Primary: PE | Rate of complete remission (CR) at week 23 - PPS

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    End point title
    		 PE | Rate of complete remission (CR) at week 23 - PPS
    End point description
    A success was defined as any patient with a complete remission or CR unconfirmed at the second tumor assessment planned at week 23, regardless of the actual assessment date. Responses at week 23: Arm A: CR=9.0%; CRu=17.9%; PR=40.3%; SD=7.5%; PD=3.0%; not done=22.4% | Arm B: CR=19.3%; CRu=21.1%; PR=47.4%; SD=3.5%; PD=5.3%; not done=3.5%. CR: complete remission, CRu: unconfirmed CR; PR: partial response; SD: stable disease; PD: progressing disease
    End point type
    Primary
    End point timeframe
    At week 23
    End point values
    		 Arm A - Rituximab | PPS Arm B - Rituximab + Lenalidomide | PPS
    Number of subjects analysed
    67
    57
    Units: % patients with CR/CRu
        number (confidence interval 95%)
    26.9 (16.8 to 39.1)
    40.4 (27.6 to 54.2)
    Statistical analysis title
    		 Z-test
    Comparison groups
    Arm B - Rituximab + Lenalidomide | PPS v Arm A - Rituximab | PPS
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.0554
    Method
    		 Z-Test
    Confidence interval
    Notes
    [3] - One-sided Z-test with unpooled variance

    Primary: PE | Rate of complete remission (CR) at week 23 - ITT || Sensitivity analysis

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    End point title
    		 PE | Rate of complete remission (CR) at week 23 - ITT || Sensitivity analysis
    End point description
    Response assessment from the independent response review (IRR). A success was defined as any patient with a complete remission or CR unconfirmed at the second tumor assessment planned at week 23, regardless of the actual assessment date. Responses at week 23: Arm A: CR=36.4%; CRu=0.0%; PR=20.8%; SD=9.1%; PD=3.9%; no measurable lesions (week 0 and week 23)=0.0%; not done=29.9% | Arm B: CR=55.8%; CRu=5.2%; PR=16.9%; SD=2.6%; PD=1.3%; no measurable lesions (week 0 and week 23)=5.2%; not done=13.0%. CR: complete remission, CRu: unconfirmed CR; PR: partial response; SD: stable disease; PD: progressing disease
    End point type
    Primary
    End point timeframe
    At week 23
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: % patients with CR/CRu
        number (confidence interval 95%)
    36.4 (25.7 to 48.1)
    61.0 (49.2 to 72.0)
    Statistical analysis title
    		 Z-test
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.0008
    Method
    		 Z-Test
    Confidence interval
    Notes
    [4] - One-sided Z-test with unpooled variance.

    Secondary: SE | Overall response (OR) - ITT

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    End point title
    		 SE | Overall response (OR) - ITT
    End point description
    Responses at week 10: Arm A: CR=3.9%; CRu=6.5%; PR=35.1%; MR=29.9; SD=16.9%; PD=5.2%; not done=2.6% | Arm B: CR=7.8%; CRu=5.2%; PR=62.3%; MR=18.2%; SD=0.0%; PD=3.9%; not done=2.6%. Responses at week 23: see description for primary endpoint. CR: complete remission, CRu: unconfirmed CR; PR: partial response; MR: minimal response; SD: stable disease; PD: progressing disease
    End point type
    Secondary
    End point timeframe
    At week 10 and week 23.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: % patients with CR/CRu/PR
    number (confidence interval 95%)
        Week 10
    45.5 (34.1 to 57.2)
    75.3 (64.2 to 84.4)
        Week 23
    61.0 (49.2 to 72.0)
    81.8 (71.4 to 89.7)
    Statistical analysis title
    		 Z-test (week 10)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.0001
    Method
    		 Z-Test
    Confidence interval
    Notes
    [5] - One-sided Z-test with unpooled variance.
    Statistical analysis title
    		 Z-test (week 23)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.0017
    Method
    		 Z-Test
    Confidence interval
    Notes
    [6] - One-sided Z-test with unpooled variance.

    Secondary: SE | Complete repsonse or overall response at 30 months - ITT

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    End point title
    		 SE | Complete repsonse or overall response at 30 months - ITT
    End point description
    Response at 30 months: Arm A: CR=18.2%; CRu=1.3%; PR=9.1%; SD=2.6%; PD=5.2%; not done=63.6% | Arm B: CR=33.8%; CRu=7.8%; PR=7.8%; SD=0.0%; PD=6.5%; not done=44.2%. CR: complete remission, CRu: unconfirmed CR; PR: partial response; SD: stable disease; PD: progressing disease
    End point type
    Secondary
    End point timeframe
    At 30 months
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: % patients with response
    number (confidence interval 95%)
        CR/CRu
    19.5 (11.3 to 30.1)
    41.6 (30.4 to 53.4)
        CR/CRu/PR
    28.6 (18.8 to 40.0)
    49.4 (37.8 to 61.0)
    Statistical analysis title
    		 Z-test (CR/CRu)
    Statistical analysis description
    One-sided Z-test with unpooled variance.
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0011
    Method
    		 Z-Test
    Confidence interval
    Statistical analysis title
    		 Z-test (CR/CRu/PR)
    Statistical analysis description
    One-sided Z-test with unpooled variance.
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0034
    Method
    		 Z-Test
    Confidence interval

    Secondary: SE | Duration of CR/CRu - ITT

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    End point title
    		 SE | Duration of CR/CRu - ITT
    End point description
    Kaplan-Meier Analysis for patients with CR/CRu. Note: Median and upper 95%-CI for arm B was not reached; dummy data "99999" entered due to database restrictions. Events | Censored: Arm A, events: 17 (54.8%), censored: 14 (45.2%) | Arm B, events: 14 (28.6%), censored: 35 (71.4%)
    End point type
    Secondary
    End point timeframe
    From baseline until CR/CRu.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    31
    49
    Units: years
        median (confidence interval 95%)
    3.2 (1.6 to 7.6)
    99999 (7.4 to 99999)
    Statistical analysis title
    		 Log Rank Test / Hazard Ratio
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0143
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.423
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.208
         upper limit
    		 0.86

    Secondary: SE | Progression free survival - ITT

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    End point title
    		 SE | Progression free survival - ITT
    End point description
    Kaplan-Meier Analysis. Note: Upper 95%-CI for arm B was not reached; dummy data "99999" entered due to database restrictions. Events | Censored: Arm A, events: 45 (58.4%; [death: 2.2%, progressive disease/relapse: 97.8%]), censored: 32 (41.6%) | Arm B, events: 36 (46.8% [death, 5.6%; progressive disease/relapse, 94.4%]), censored: 41 (53.2%)
    End point type
    Secondary
    End point timeframe
    From baseline until progression.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: years
        median (confidence interval 95%)
    2.3 (1.6 to 3.5)
    9.3 (2.5 to 99999)
    Statistical analysis title
    		 Log Rank Test / Hazard Ratio
    Comparison groups
    Arm B - Rituximab + Lenalidomide | ITT v Arm A - Rituximab | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0128
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.575
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.894

    Secondary: SE | Progression free survival Survival estimates at 2, 3, 5 and 10 years - ITT

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    End point title
    		 SE | Progression free survival Survival estimates at 2, 3, 5 and 10 years - ITT
    End point description
    End point type
    Secondary
    End point timeframe
    At 2, 3, 5 and 10 years.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: PFS probability (%)
    number (confidence interval 95%)
        2-year PFS
    58.8 (45.3 to 70.0)
    67.5 (55.2 to 77.1)
        3-year PFS
    43.1 (30.3 to 55.2)
    57.2 (44.8 to 67.9)
        5-year PFS
    33.7 (21.9 to 46.0)
    54.0 (41.5 to 64.9)
        10-year PFS
    20.9 (10.5 to 33.8)
    36.1 (17.7 to 54.9)
    Statistical analysis title
    		 2-year PFS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.303
    Method
    		 cloglog (log(-log(.)))
    Confidence interval
    Statistical analysis title
    		 3-year PFS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1095
    Method
    		 cloglog (log(-log(.)))
    Confidence interval
    Statistical analysis title
    		 5-year PFS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0228
    Method
    		 cloglog (log(-log(.)))
    Confidence interval
    Statistical analysis title
    		 10-year PFS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1921
    Method
    		 cloglog (log(-log(.)))
    Confidence interval

    Secondary: SE | Time to first off-trial anti-lymphoma therapy - ITT

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    End point title
    		 SE | Time to first off-trial anti-lymphoma therapy - ITT
    End point description
    Kaplan-Meier Analysis. Note: Median and upper 95%-CI for arm B was not reached; dummy data "99999" entered due to database restrictions. Events | Censored: Arm A, events: 52 (67.5%), censored: 25 (32.5%) | Arm B, events: 30 (39.0%), censored: 47 (61.0%)
    End point type
    Secondary
    End point timeframe
    From baseline until time to first off-trial anti-lymphoma therapy.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: years
        median (confidence interval 95%)
    2.1 (1.5 to 3.6)
    99999 (4.3 to 99999)
    Statistical analysis title
    		 Log-rank test / Hazard Ratio
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.427
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.272
         upper limit
    		 0.672

    Secondary: SE | Overall survival - ITT

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    End point title
    		 SE | Overall survival - ITT
    End point description
    Kaplan-Meier Analysis. Note: Median and 95%-CI for arm A and arm B were not reached; dummy data "99999" entered due to database restrictions. Events | Censored: Arm A, events: 14 (18.2%), censored: 63 (81.8%) | Arm B, events: 15 (19.5%), censored: 62 (80.5%) Causes of death: Arm A, other: 4 (30.8%), tumor: 6 (46.2%), unknown: 3 (23.1%) | Arm B, other: 3 (20.0%), tumor: 8 (53.3%), unknown: 4 (26.7%)
    End point type
    Secondary
    End point timeframe
    From baseline until death.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: years
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Log-rank test / Hazard Ratio
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9609
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.982
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.474
         upper limit
    		 2.035

    Secondary: SE | Overall survival Survival estimates at 3, 5 and 10 years - ITT

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    End point title
    		 SE | Overall survival Survival estimates at 3, 5 and 10 years - ITT
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 5 and 10 years.
    End point values
    		 Arm A - Rituximab | ITT Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects analysed
    77
    77
    Units: years
    median (confidence interval 95%)
        3-year OS probability
    91.8 (82.6 to 96.2)
    93.3 (84.7 to 97.2)
        5-year OS probability
    90.3 (80.7 to 95.2)
    90.6 (81.3 to 95.4)
        10-year OS probability
    78.0 (65.4 to 86.4)
    76.8 (63.9 to 85.6)
    Statistical analysis title
    		 3-year OS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7187
    Method
    		 cloglog (log(-log(.)))
    Confidence interval
    Statistical analysis title
    		 5-year OS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9419
    Method
    		 cloglog (log(-log(.)))
    Confidence interval
    Statistical analysis title
    		 10-year OS (p-value)
    Comparison groups
    Arm A - Rituximab | ITT v Arm B - Rituximab + Lenalidomide | ITT
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.881
    Method
    		 cloglog (log(-log(.)))
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization until the second restaging at week 23 or until 30 days after end of trial treatment or prior to start of next therapy (whatever was first).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Arm A - Rituximab | SAF
    Reporting group description
    		 One randomized patient did not receive study treatment and was excluded from the SAF.

    Reporting group title
    Arm B - Rituximab + Lenalidomide | SAF
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A - Rituximab | SAF Arm B - Rituximab + Lenalidomide | SAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 76 (14.47%)
    30 / 77 (38.96%)
         number of deaths (all causes)
    13
    15
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
    Additional description: One patient death due to neoplasm progression (not related to trial therapy) and the other neoplasm progression and pyrexia.
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
    Additional description: One patient with non-small cell lung cancer (adenocarcinoma) and the other with non-small cell lung cancer (lung adenocarcinoma stage 0)
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary myelofibrosis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
    Additional description: Patient with rib fracture complicated by haemothorax.
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: One patient with atrial fibrillation, thrombocytopenia, leukopenia, anaemia and urinary tract infection.
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    Additional description: One patient with pyrexia and rash.
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
    Additional description: Patient with drug withdrawal syndrome manifested in paranoid schizophrenia.
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Subileus
    Additional description: Patient with subileus and abdominal pain.
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
    Additional description: Patient with stomatitis, generalised oedema and urticaria.
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression suicidal
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
    Additional description: Patient with anxiety resulting in dyspnoea.
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Patient with urinary tract infection and calculus urinary.
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A - Rituximab | SAF Arm B - Rituximab + Lenalidomide | SAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 76 (90.79%)
    77 / 77 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 76 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    Hypertension
         subjects affected / exposed
    13 / 76 (17.11%)
    18 / 77 (23.38%)
         occurrences all number
    13
    19
    Hypotension
         subjects affected / exposed
    3 / 76 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    Embolism
         subjects affected / exposed
    0 / 76 (0.00%)
    4 / 77 (5.19%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    3 / 76 (3.95%)
    4 / 77 (5.19%)
         occurrences all number
    4
    4
    Oedema peripheral
         subjects affected / exposed
    2 / 76 (2.63%)
    12 / 77 (15.58%)
         occurrences all number
    2
    14
    Fatigue
         subjects affected / exposed
    26 / 76 (34.21%)
    40 / 77 (51.95%)
         occurrences all number
    28
    47
    Pyrexia
         subjects affected / exposed
    11 / 76 (14.47%)
    12 / 77 (15.58%)
         occurrences all number
    16
    13
    Influenza like illness
         subjects affected / exposed
    5 / 76 (6.58%)
    8 / 77 (10.39%)
         occurrences all number
    5
    8
    Pain
         subjects affected / exposed
    5 / 76 (6.58%)
    3 / 77 (3.90%)
         occurrences all number
    5
    3
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    3 / 76 (3.95%)
    6 / 77 (7.79%)
         occurrences all number
    3
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 76 (13.16%)
    19 / 77 (24.68%)
         occurrences all number
    10
    23
    Dyspnoea
         subjects affected / exposed
    6 / 76 (7.89%)
    10 / 77 (12.99%)
         occurrences all number
    6
    11
    Oropharyngeal pain
         subjects affected / exposed
    3 / 76 (3.95%)
    5 / 77 (6.49%)
         occurrences all number
    3
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 77 (3.90%)
         occurrences all number
    4
    3
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 76 (1.32%)
    6 / 77 (7.79%)
         occurrences all number
    1
    7
    Neutrophil count decreased
         subjects affected / exposed
    3 / 76 (3.95%)
    14 / 77 (18.18%)
         occurrences all number
    3
    18
    Weight increased
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    1
    4
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    11 / 76 (14.47%)
    5 / 77 (6.49%)
         occurrences all number
    11
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 76 (2.63%)
    9 / 77 (11.69%)
         occurrences all number
    2
    9
    Dysgeusia
         subjects affected / exposed
    0 / 76 (0.00%)
    4 / 77 (5.19%)
         occurrences all number
    0
    5
    Headache
         subjects affected / exposed
    7 / 76 (9.21%)
    12 / 77 (15.58%)
         occurrences all number
    7
    12
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 76 (5.26%)
    19 / 77 (24.68%)
         occurrences all number
    4
    22
    Constipation
         subjects affected / exposed
    12 / 76 (15.79%)
    29 / 77 (37.66%)
         occurrences all number
    13
    30
    Diarrhoea
         subjects affected / exposed
    9 / 76 (11.84%)
    19 / 77 (24.68%)
         occurrences all number
    9
    28
    Dyspepsia
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    1
    4
    Nausea
         subjects affected / exposed
    10 / 76 (13.16%)
    10 / 77 (12.99%)
         occurrences all number
    12
    10
    Abdominal pain upper
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 77 (2.60%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    4 / 76 (5.26%)
    11 / 77 (14.29%)
         occurrences all number
    5
    12
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    1
    4
    Erythema multiforme
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    1
    4
    Hyperhidrosis
         subjects affected / exposed
    0 / 76 (0.00%)
    6 / 77 (7.79%)
         occurrences all number
    0
    6
    Pruritus
         subjects affected / exposed
    3 / 76 (3.95%)
    11 / 77 (14.29%)
         occurrences all number
    3
    11
    Dermatitis acneiform
         subjects affected / exposed
    2 / 76 (2.63%)
    4 / 77 (5.19%)
         occurrences all number
    2
    5
    Rash maculo-papular
         subjects affected / exposed
    2 / 76 (2.63%)
    16 / 77 (20.78%)
         occurrences all number
    3
    19
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 76 (2.63%)
    6 / 77 (7.79%)
         occurrences all number
    2
    6
    Back pain
         subjects affected / exposed
    8 / 76 (10.53%)
    3 / 77 (3.90%)
         occurrences all number
    8
    4
    Myalgia
         subjects affected / exposed
    4 / 76 (5.26%)
    5 / 77 (6.49%)
         occurrences all number
    5
    5
    Pain in extremity
         subjects affected / exposed
    2 / 76 (2.63%)
    7 / 77 (9.09%)
         occurrences all number
    2
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 76 (7.89%)
    3 / 77 (3.90%)
         occurrences all number
    6
    3
    Rhinitis
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
         occurrences all number
    1
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 76 (2.63%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 76 (7.89%)
    13 / 77 (16.88%)
         occurrences all number
    7
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2011
    Update of section 17 of the protocol 'Translational research' and implementation of administrative changes. In addition the information regarding secondary primary malignancies of lenalidomide were taken into account in the protocol and in the patient information sheet. An additional exclusion criteria regarding compressive syndrome was added as well.

    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.
    Quality of life and patient reported outcomes could not be assessed, which may be regarded as a potential limitation of this study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31101627
    http://www.ncbi.nlm.nih.gov/pubmed/32012230
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