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NCT05556616 · OUTCOME

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

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 2 years after CR confirmation

What was measured

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.

Analysis population: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).

Groups in this outcome

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 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg0
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg0
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
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.
groups
  1. 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
    OG000
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
  2. 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
    OG001
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
  3. 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
    OG002
    title
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
population Description
MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).
reporting Status
POSTED
time Frame
Up to 2 years after CR confirmation
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
type
SECONDARY

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

Preserved source evidence · Not medical advice