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    Clinical Trial Results:
    Phase II multicenter, open‐label, single arm clinical Study of Pomalidomide and dexamethasonE in RelapSed myeloma Plus rEsponse adapted Cyclophosphamide as a Tailored InnoVativE strategy

    Summary
    EudraCT number
    		 2013-003678-29
    Trial protocol
    		 DE  
    Global end of trial date
    17 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2020
    First version publication date
    17 Oct 2020
    Other versions
    Summary report(s)
    		 Adverse Events

    Trial information

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    Trial identification
    Sponsor protocol code
    PERSPECTIVE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02046915
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Tübingen
    Sponsor organisation address
    Geissweg , Tuebinegn, Germany,
    Public contact
    Study Office, Universitätsklinikum Tübingen, birtta.besemer@med.uni-tuebingen.de
    Scientific contact
    Study Office, Universitätsklinikum Tübingen, britta.besemer@med.uni-tuebingen.de
    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
    07 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the best objective response
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and the ICH Guidelines in Good Clinical Practice. The study was not started before the competent ethics committee had given a favorable opinion. Written informed consent was obtained from all patients and the study was only conducted as approved by the Ethics committee and the competent authority. Amendments were only implemented after approval
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    17
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in 8 German centers. Date of first patient enrollment: 18.06.2014 Date Last Patient Last Visit defined as 2 years after last subject enrolment: 17.08.2017

    Pre-assignment
    Screening details
    		 Adult male and female patients with RRMM and fulfilling the inclusion and exclusion criteria were enrolled into the study. Trial population consisted of both genders. Gender distribution in the trial is supposed to reflect the distribution in the real patient’s population (approx. 60% male and 40% female patients)

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

    Arms
    Arm title
    		 Pomalidomide
    Arm description
    		 Pomalidomide was administered orally at the starting dose of 4 mg/day on days 1-21 of a 28 day cycle. In case of suboptimal response (DS, MR), from Cycle 4 Day1 or of first evidence of progressive disease at cycle 2, 3, 4 the subject received 500mg/m2 at day1 and day15 Treatment continued until disease progression or unacceptable toxicity Cyclophoshamide was administrated for a maximum of 12 cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral Pomalidomide at the starting dose of 4 mg on Days 1–21 of a 28-day cycle

    Number of subjects in period 1 [1]
    		Pomalidomide
    Started
    59
    Completed
    59
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The trial has recruited 60 patients. The intention-to-treat (ITT) population (59 patients) is defined according to the intention-to-treat principle and consists of all patients included in the study with written informed consent, excluding patients with violation of major eligibility criteria. As per principle investigator decision, included patients without 'at least two prior anti- myeloma regimen and progression under the last prior treatment' (inclusion criterion 5) are excluded from IT

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pomalidomide Teatment
    Reporting group description
    		 Patients recieved: Oral Pomalidomide at the starting dose of 4 mg on Days 1–21 of a 28-day cycle; In case of suboptimal response (SD, MR) from Cycle 4 Day 1 (C4D1) or of first evidence of progressive disease at C2, C3 or C4, the subject received: Cyclophosphamide: 500 mg/m² D1, D15 Treatment continued until disease progression or unacceptable toxicity (whichever occurs first). Cyclophosphamide was administered for a maximum of 12 cycles.

    Reporting group values
    		 Pomalidomide Teatment Total
    Number of subjects
    		 59 59
    Age categorical
    Units: Subjects
        Age 18-99
    		 59 59
    Gender categorical
    Units: Subjects
        Female
    		 32 32
        Male
    		 27 27
    ECOG PS
    Units: Subjects
        ECOG 0
    		 23 23
        ECOG 1
    		 27 27
        ECOG 2
    		 6 6
        ECOG missing
    		 3 3
    ISS Stage
    Units: Subjects
        ISS Stage I
    		 18 18
        ISS Stage II
    		 17 17
        ISS Stage III
    		 19 19
        ISS not determined
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Values at baseline

    Subject analysis sets values
    		 Baseline
    Number of subjects
    59
    Age categorical
    Units: Subjects
        Age 18-99
    59
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    ECOG PS
    Units: Subjects
        ECOG 0
        ECOG 1
        ECOG 2
        ECOG missing
    ISS Stage
    Units: Subjects
        ISS Stage I
        ISS Stage II
        ISS Stage III
        ISS not determined

    End points

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    End points reporting groups
    Reporting group title
    Pomalidomide
    Reporting group description
    		 Pomalidomide was administered orally at the starting dose of 4 mg/day on days 1-21 of a 28 day cycle. In case of suboptimal response (DS, MR), from Cycle 4 Day1 or of first evidence of progressive disease at cycle 2, 3, 4 the subject received 500mg/m2 at day1 and day15 Treatment continued until disease progression or unacceptable toxicity Cyclophoshamide was administrated for a maximum of 12 cycle

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Values at baseline

    Primary: ORR

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    End point title
    		 ORR
    End point description
    The primary endpoint is the objective response rate (ORR) during treatment period (maximum 2 years). The one-sided null hypothesis tested is H0 : ORR 30% against the alternative H1 : ORR > 30%. The null hypothesis will be rejected if 21 responder Among 59 evaluable patients are 23 non responders. Therefore the null hypothesis of ORR ≤30 cannot be rejected
    End point type
    Primary
    End point timeframe
    The primary endpoint is the objective response rate (ORR) during treatment period (maximum 2 years). The one-sided null hypothesis tested is H0 : ORR 30% against the alternative H1 : ORR > 30%. The null hypothesis will be rejected if 21 responder
    End point values
    		 Pomalidomide Baseline
    Number of subjects analysed
    59
    59
    Units: events
    number (not applicable)
        missing
    2
    0
        Progression Disease
    5
    59
        Stable Disease
    13
    0
        minimal response
    16
    0
        Partial Response
    14
    0
        Very Godd Partial Disease
    7
    0
        Complete Response
    2
    0
    Statistical analysis title
    		 primary satistical analyis
    Statistical analysis description
    The primary endpoint is the objective response rate (ORR) during treatment period (maximum 2 years). The one-sided null hypothesis tested is H0 : ORR 30% against the alternative H1 : ORR > 30%. The null hypothesis will be rejected if 21 responders are among 53 evaluable patients.
    Comparison groups
    Pomalidomide v Baseline
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 rate existimate
    Point estimate
    0.3898
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.2923
         upper limit
    		 -

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    all AEs that occur after the subject has received the first drug dose up to 30 days after the last dose or until the beginning of a new therapy, whichever occurs first will be documented in the CRF
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0 PT
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Table of Adverse Events will be attached

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2015
    Following the release of the Rote-Hand-Brief by Celgene in April 2015, the “Pomalidomide Pregancy Prevendtion plan for Subjects in clinical Trials” had been updated and the recommendation on contraception for female patients (female partner of patients) of childbearing potential and the frequency of the Pregnancy Test had been implemented.

    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/30962424
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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