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NCT06055075 · OUTCOME

Investigator-assessed Overall Survival (OS)

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-29

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 15.7 months

What was measured

OS was defined as the time from randomization to death from any cause as determined by the investigator per IMWG response criteria. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.

Analysis population: Efficacy-evaluable population included all response evaluable participants, i.e., those who received at least one dose of one of their assigned study treatments and had at least one baseline and one on-treatment tumor assessment or those who had one tumor assessment at baseline and discontinued their treatment for any reason before their first on-treatment tumor assessment. Overall number analyzed is the number of participants with data available for analysis

Groups in this outcome

Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib

Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib

Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib

Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib7
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib6
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib6

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + CarfilzomibNANot reportedNANAMedian and 95% CI were not estimable due to insufficient number of participants with events.
Cohort 1: Arm B2: Forimtamig 0.75 mg + CarfilzomibNANot reportedNANAMedian and 95% CI were not estimable due to insufficient number of participants with events.
Cohort 1: Arm B3: Forimtamig 1.5 mg + CarfilzomibNANot reportedNANAMedian and 95% CI were not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% CI were not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI were not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median and 95% CI were not estimable due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
OS was defined as the time from randomization to death from any cause as determined by the investigator per IMWG response criteria. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG000
    title
    Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
  2. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG001
    title
    Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
  3. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    OG002
    title
    Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
param Type
MEDIAN
population Description
Efficacy-evaluable population included all response evaluable participants, i.e., those who received at least one dose of one of their assigned study treatments and had at least one baseline and one on-treatment tumor assessment or those who had one tumor assessment at baseline and discontinued their treatment for any reason before their first on-treatment tumor assessment. Overall number analyzed is the number of participants with data available for analysis
reporting Status
POSTED
time Frame
Up to approximately 15.7 months
title
Investigator-assessed Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice