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    Clinical Trial Results:
    A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma

    Summary
    EudraCT number
    		 2022-001418-20
    Trial protocol
    		 ES  
    Global end of trial date
    04 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2025
    First version publication date
    11 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-573-1502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05556616
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Ave, Lexington, MA, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objectives of the trial were to determine the safety and tolerability of modakafusp alfa and lenalidomide combination therapy as maintenance in adult patients with newly diagnosed multiple myeloma (NDMM) after autologous stem cell transplant (ASCT), modakafusp alfa as part of 2-drug combination therapy in adult patients with relapsed/refractory multiple myeloma (RRMM) and modakafusp alfa as part of 3-drug combination therapy in adult patients with RRMM; to determine the recommended Phase 2 dose (RP2D) of the combination therapy with modakafusp alfa, modakafusp alfa (recommended doses of the doublet combinations) for RRMM Doublet Combinations (Doublets) and modakafusp alfa (recommended doses of the triplet combinations) for RRMM Triplet Combinations (Triplets).
    Protection of trial subjects
    Each participant signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    12 Jan 2023
    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
    Belgium: 2
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    14
    EEA total number of subjects
    2
    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)
    4
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at various investigative sites globally from 12 January 2023 to 04 June 2024.

    Pre-assignment
    Screening details
    		 Participants with a diagnosis of multiple myeloma (MM) enrolled;those newly diagnosed with MM(NDMM) received modakafusp alfa + lenalidomide; participants with relapsed/refractory MM(RRMM)received modakafusp alfa+pomalidomide/carfilzomib. Due to early termination, no participants enrolled in Group2 Arm 4:modakafusp alfa+bortezomib and Group 3 arms.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg
    Arm description
    		 Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD [-]) participants, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD [-] negative participants, whichever occurred first.

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD [-] negative participants, whichever occurred first.

    Arm title
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Arm description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Arm title
    		 Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg
    Arm description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Arm title
    		 Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Arm description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carfilzomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 20/70 milligrams per meter square (mg/m^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Number of subjects in period 1
    		Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Started
    3
    4
    4
    3
    Completed
    2
    1
    2
    2
    Not completed
    1
    3
    2
    1
         Adverse event, serious fatal
    -
    -
    2
    1
         Consent withdrawn by subject
    1
    -
    -
    -
         Study Terminated by Sponsor
    -
    3
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg
    Reporting group description
    		 Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD [-]) participants, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2 Total
    Number of subjects
    		 3 4 4 3
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ( 18.50 ) 64.3 ( 11.00 ) 71.3 ( 2.63 ) 57.3 ( 12.06 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 0 2 0 4
        Male
    		 1 4 2 3 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 1 1 2 1 5
        White
    		 2 1 2 2 7
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 2 0 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 2 2 4 3 11
        Unknown or Not Reported
    		 1 2 0 0 3

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg
    Reporting group description
    		 Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD [-]) participants, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Primary: Number of Participants With Dose-limiting Toxicities (DLTs)

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    End point title
    		 Number of Participants With Dose-limiting Toxicities (DLTs) [1]
    End point description
    DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions. The DLT-evaluable Analysis Set included participants who experienced a DLT in Cycle 1 in the treatment phase of the study or completed Cycle 1 procedures and received a full Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of the combination partner. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
    End point type
    Primary
    End point timeframe
    Cycle 1 (Cycle length is 28 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    2
    3
    4
    2
    Units: participants
    0
    1
    1
    2
    No statistical analyses for this end point

    Primary: Number of Participants With one or More Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With one or More Treatment Emergent Adverse Events (TEAEs) [2]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
    End point type
    Primary
    End point timeframe
    Up to 16.7 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    3
    4
    4
    3
    Units: participants
    3
    3
    4
    3
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS:time from date of 1st dose of study drug administration to date of 1st documentation of confirmed progression of disease(PD)/death due to any cause,whichever occurs first.PD:determined by International Myeloma Working Group(IMWG)criteria.PD:≥25%increase from lowest response value in≥1of:serum M-component increase≥0.5gram per deciliter(g/dL)/urine M-component increase≥200mg/24-hour;difference between involved & uninvolved free light chains(FLC)levels increase must be>10mgperdeciliter;bone marrow plasma cell≥10%;definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas;development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.Due to early study termination,short follow-up & small population data could not be adequately interpreted.No participants enrolled in Group2Arm4:modakafusp alfa+bortezomib&Group3 arms due to early study termination,thus not presented.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: months
    Notes
    [3] - The pre-planned efficacy analysis could not be adequately interpreted due to early termination.
    [4] - The pre-planned efficacy analysis could not be adequately interpreted due to early termination.
    [5] - The pre-planned efficacy analysis could not be adequately interpreted due to early termination.
    [6] - The pre-planned efficacy analysis could not be adequately interpreted due to early termination.
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [7]
    End point description
    ORR was defined as the percentage of participants who achieved a confirmed partial response rate (PR) or better (stringent complete response [sCR] + complete response [CR] + very good partial response [VGPR] + PR) during the study as defined by IMWG uniform response criteria and as determined by the investigator. PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or less than (<) 200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to the nearest single decimal place.The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    4
    4
    3
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.00 to 60.24)
    50 (6.76 to 93.24)
    33.3 (0.84 to 90.57)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR:time from1st documentation of confirmed PR/better(sCR+CR+VGPR+PR)to1st documentation of PD/death due to any cause.PR:≥50%reduction(serum M-protein)&≥90%reduction(urine M-protein)/<200mg/24hr/≥50%decrease(uninvolved FLC)/≥50%reduction(plasma cells).At BL,≥50%decrease(size of soft tissue plasmacytomas).PD:≥25%increase from lowest response value in any one/more of:serum M-component increase≥0.5 g/dL/urine M-component increase≥200mg/24-hour;difference between involved&>10mg/dLincrease in uninvolved FLC levels; ≥10%bone marrow plasma cell;definite development(new bone lesions)/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas;development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.Due to early termination,short follow-up&small population,pre-planned efficacy analysis was not adequately interpreted.No participants enrolled in Group2Arm4&Group 3 arms due to termination,thus not presented.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [8] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [9] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [10] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [11] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Disease Control Rate (DCR)

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    End point title
    		 Groups 2 and 3: Disease Control Rate (DCR) [12]
    End point description
    DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place. The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    4
    4
    3
    Units: percentage of participants
        number (confidence interval 95%)
    75.0 (19.41 to 99.37)
    50.0 (6.76 to 93.24)
    66.7 (9.43 to 99.16)
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Time to Next Treatment (TTNT)

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    End point title
    		 Groups 2 and 3: Time to Next Treatment (TTNT) [13]
    End point description
    TTNT was defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [14] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [15] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [16] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Overall Survival (OS)

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    End point title
    		 Groups 2 and 3: Overall Survival (OS) [17]
    End point description
    OS was defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [18] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [19] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [20] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Time to Progression (TTP)

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    End point title
    		 Groups 2 and 3: Time to Progression (TTP) [21]
    End point description
    TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [22] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [23] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [24] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Percentage of Participants with MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator

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    End point title
    		 Groups 2 and 3: Percentage of Participants with MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator [25]
    End point description
    Rate of MRD negativity CR status a sensitivity of 10^-5 was defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 2 years after CR confirmation
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    Units: percentage of participants
        number (not applicable)
    Notes
    [26] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [27] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [28] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Event-free Survival (EFS)

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    End point title
    		 Groups 2 and 3: Event-free Survival (EFS) [29]
    End point description
    EFS:time from date of 1st dose of study drug administration to date of 1st documentation of event that may include confirmed PD,discontinuation of treatment for AE(related/not related),or death due to any cause,whichever occurs first.PD:determined by IMWG criteria.PD:increase of ≥25% from lowest response value in ≥1 of:serum M-component increase ≥0.5g/dL/urine M-component increase ≥200mg/24-hour;difference between involved & uninvolved FLC levels increase must be >10mg/dL;bone marrow plasma cell ≥10%;definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions/soft tissue plasmacytomas;development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.Due to early study termination,short follow-up & small population data could not be adequately interpreted.No participants enrolled in Group2Arm4:modakafusp alfa+bortezomib & Group3 arms due to early study termination,thus not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [30] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [31] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [32] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Time to Response (TTR)

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    End point title
    		 Groups 2 and 3: Time to Response (TTR) [33]
    End point description
    TTR was defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [34] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [35] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [36] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5

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    End point title
    		 Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5 [37]
    End point description
    Rate of MRD negativity at a sensitivity of 10^-5 was defined as the percentage of participants who achieved MRD negative status in the MRD-evaluable analysis set. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted.
    End point type
    Secondary
    End point timeframe
    At 6 months, 1 year, and 2 years after the start of treatment
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg
    Number of subjects analysed
    0 [38]
    Units: percentage of participants
        number (not applicable)
    Notes
    [38] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)

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    End point title
    		 Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)
    End point description
    Due to early study termination, the short follow-up of the participants and the small population, the pre-planned analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    Units: participants
    Notes
    [39] - Immunogenicity not interpreted adequately due to study termination,short follow-up,small population.
    [40] - Immunogenicity not interpreted adequately due to study termination,short follow-up,small population.
    [41] - Immunogenicity not interpreted adequately due to study termination,short follow-up,small population.
    [42] - Immunogenicity not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity

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    End point title
    		 Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity [43]
    End point description
    Duration of MRD negativity (10^-5) was defined as time from date of first documentation of MRD[-] to first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first.PD: increase of ≥25% from lowest response value in any one or more of the following:serum M-component increase ≥0.5 g/dL or urine M-component increase ≥200 mg/24-hour;difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell ≥10%;definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.Due to early study termination,short follow-up & small population,the pre-planned efficacy analysis could not be adequately interpreted.No participants were enrolled in Group2Arm4 & Group 3 arms due to early study termination, thus are not reported here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [44]
    0 [45]
    0 [46]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [44] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [45] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [46] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Group 2 and 3: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5

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    End point title
    		 Group 2 and 3: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5 [47]
    End point description
    Rate of MRD negativity at a sensitivity of 10^-5 was defined as the percentage of participants who have achieved MRD negative status. Due to early study termination, the short follow-up of the participants and the small population, the pre-planned efficacy analysis could not be adequately interpreted. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 16.7 months
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [48]
    0 [49]
    0 [50]
    Units: percentage of participants
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [48] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [49] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [50] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Secondary: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity

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    End point title
    		 Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
    End point description
    Duration of MRD negativity (10^-5):time from the date of 1st documentation of MRD[-] to 1st documentation of MRD positivity or confirmed PD or death due to any cause,whichever occurred first.PD:increase of ≥25% from lowest response value in any one or more of the following:serum M-component increase ≥0.5g/dL or urine M-component increase ≥200mg/24-hour;difference between involved & uninvolved FLC levels increase must be >10mg/dL;bone marrow plasma cell ≥10%;definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas;development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.Due to early study termination,short follow-up & small population,the pre-planned efficacy analysis could not be adequately interpreted.No participants enrolled in Group2Arm4:modakafusp alfa+bortezomib and Group 3 arms due to early study termination, thus they are not presented here.
    End point type
    Secondary
    End point timeframe
    Up to 2 years after treatment
    End point values
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg Group 2 (RRMM Doublets): Modakafusp alfa +Pomalidomide 4 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Number of subjects analysed
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [51] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [52] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [53] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    [54] - Efficacy was not interpreted adequately due to study termination,short follow-up,small population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 16.7 months
    Adverse event reporting additional description
    The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg
    Reporting group description
    		 Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD [-]) participants, whichever occurred first.

    Reporting group title
    Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 4 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Reporting group title
    Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Reporting group description
    		 Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.

    Serious adverse events
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 4 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 3 (100.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    1
    2
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia influenzal
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 (NDMM): Modakafusp alfa + Lenalidomide 10 mg Group 2(RRMM Doublets):Modakafusp alfa+Carfilzomib 20/70mg/m^2 Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 4 mg Group 2 (RRMM Doublets): Modakafusp alfa + Pomalidomide 2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
         occurrences all number
    1
    0
    2
    2
    Inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    Suprapubic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    0
    1
    Delirium
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    9
    4
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Bundle branch block left
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Right ventricular dysfunction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 4 (75.00%)
    2 / 4 (50.00%)
         occurrences all number
    3
    11
    3
    3
    Leukopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    13
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    3 / 4 (75.00%)
    3 / 4 (75.00%)
         occurrences all number
    9
    14
    16
    7
    Neutropenia
         subjects affected / exposed
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    3 / 4 (75.00%)
    3 / 4 (75.00%)
         occurrences all number
    15
    0
    17
    11
    Lymphopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    9
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anal incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hepatobiliary disorders
    Portal hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Sacral pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Salmonella bacteraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2022
    The following changes were made as per Amendment 01: Added an exclusion criterion for patients who had previously received modakafusp alfa. 2. Revised several procedures in the schedules of events.
    17 Aug 2022
    The following changes were made as per Amendment 02: 1. Removed modakafusp alfa and daratumumab arm (Arm 5 in Group 2 RRMM Doublets). 2. Removed secondary objectives relating to daratumumab pharmacokinetics (PK). 3. Reduced the modakafusp alfa starting dose. 4. Revised the prior therapy inclusion criterion. 5.Updated pregnancy testing timepoints and modalities, and contraception language (period of contraception and method). 6. Updated imaging assessment schedules. 7. Removed baseline human immunodeficiency (HIV) and hepatitis C virus testing.
    13 Jun 2023
    The following changes were made as per Amendment 03: 1. Revised the study design. 2. Updated clinical data from ongoing modakafusp alfa studies. 3. Added event-free survival (EFS) as a secondary endpoint. 4. Closed the combination arm with carfilzomib and added contraindications to concurrent carfilzomib and modakafusp alfa treatment. 5. Revised the pomalidomide and bortezomib dosing schedules.
    03 Apr 2024
    The following change was made as per Amendment 04: 1. Added new modakafusp alfa dose modification guidelines.

    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.
    Due to early termination of study for strategic reasons no participants enrolled in Group 2Arm4:modakafusp alfa+bortezomib &Group 3 arms.Endpoint data related toPFS,OS,DOR,TTP,TTNT,EFS,TTR,&MRD not collected as planned&thus not reported.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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