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NCT06055075 · OUTCOME

Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria

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 15.2 months

What was measured

PFS=time from randomization until disease progression (PD) per IMWG criteria or death from any cause. PD=any 1 or more of the following: Increase of 25% from lowest response value in any of the following: Serum M-component, Urine M-component or in participants without measurable SMP \& UMP levels: difference between involved \& uninvolved FLC levels; For non-secretory participants at study entry: in participants without measurable SMP \& UMP levels \& without measurable disease by FLC: BM plasma cell percentage irrespective of baseline status (absolute %must be ≥10%); appearance of a new lesion/s, ≥ 50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1centimeters (cm) in short axis; Definite development of new bone lesions/definite increase in the size of existing bone lesions; ≥50% increase in circulating plasma cells. Kaplan-Meier (K-M) method was used to estimate the median PFS. Overall number analyzed=participants with an event.

Analysis population: The lower limit of the 95% CI was estimable due to the standard methodology used in K-M survival analysis (Brookmeyer \& Crowley method used by SAS). In this analysis, CI for median is not based on number of events, but on CI of the survival curve over time. Due to small sample size, statistical software identifies the first time point where the true median could plausibly be reached as the lower limit of the 95% CI, even though the median has not been reached and remains not estimable.

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 + Carfilzomib1
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib3
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib3

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + CarfilzomibNANot reported8.9NAMedian and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
Cohort 1: Arm B2: Forimtamig 0.75 mg + CarfilzomibNANot reported6.5NAMedian and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib10.8Not reported5.6NAUpper limit of 95% CI was not estimated due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        8.9
        upper Limit
        NA
        value
        NA
      2. comment
        Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        6.5
        upper Limit
        NA
        value
        NA
      3. comment
        Upper limit of 95% CI was not estimated due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        5.6
        upper Limit
        NA
        value
        10.8
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    units
    Participants
description
PFS=time from randomization until disease progression (PD) per IMWG criteria or death from any cause. PD=any 1 or more of the following: Increase of 25% from lowest response value in any of the following: Serum M-component, Urine M-component or in participants without measurable SMP \& UMP levels: difference between involved \& uninvolved FLC levels; For non-secretory participants at study entry: in participants without measurable SMP \& UMP levels \& without measurable disease by FLC: BM plasma cell percentage irrespective of baseline status (absolute %must be ≥10%); appearance of a new lesion/s, ≥ 50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1centimeters (cm) in short axis; Definite development of new bone lesions/definite increase in the size of existing bone lesions; ≥50% increase in circulating plasma cells. Kaplan-Meier (K-M) method was used to estimate the median PFS. Overall number analyzed=participants with an event.
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
The lower limit of the 95% CI was estimable due to the standard methodology used in K-M survival analysis (Brookmeyer \& Crowley method used by SAS). In this analysis, CI for median is not based on number of events, but on CI of the survival curve over time. Due to small sample size, statistical software identifies the first time point where the true median could plausibly be reached as the lower limit of the 95% CI, even though the median has not been reached and remains not estimable.
reporting Status
POSTED
time Frame
Up to approximately 15.2 months
title
Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice