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NCT05556616 · OUTCOME

Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma · Source last updated 2026-01-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 16.7 months

What was measured

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.

Analysis population: 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.

Groups in this outcome

Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg

Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, 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 MRD \[-\] negative participants, whichever occurred first.

Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg

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.

Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg

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.

Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg3
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg4
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg4
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^23

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg3Not reportedNot reportedNot reportedNot reported
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg3Not reportedNot reportedNot reportedNot reported
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg4Not reportedNot reportedNot reportedNot reported
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    units
    Participants
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.
groups
  1. description
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, 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 MRD \[-\] negative participants, whichever occurred first.
    id
    OG000
    title
    Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
  2. 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.
    id
    OG001
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
  3. 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.
    id
    OG002
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
  4. 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.
    id
    OG003
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
Up to 16.7 months
title
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice