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NCT06055075 · OUTCOME

Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better

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

DoR was defined as the time from the initial objective response (OR) (sCR, CR, PR, or VGPR) to the time of PD or death from any cause as determined by the investigator per IMWG response criteria. CR, sCR, VGPR, and PR were defined the same as outlined in the description for the primary endpoint ORR. PD was defined as outlined in the description for the endpoint PFS. K-M method was used to estimate the median DOR.

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 an OR.

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 + Carfilzomib6
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib5
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Arm B1: Forimtamig 0.3 mg + CarfilzomibNANot reported6.9NAMedian 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 reported5.6NAMedian 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 + Carfilzomib7.2Not reported4.6NAUpper limit of 95% CI was not estimable 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
        6.9
        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
        5.6
        upper Limit
        NA
        value
        NA
      3. comment
        Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        4.6
        upper Limit
        NA
        value
        7.2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    units
    Participants
description
DoR was defined as the time from the initial objective response (OR) (sCR, CR, PR, or VGPR) to the time of PD or death from any cause as determined by the investigator per IMWG response criteria. CR, sCR, VGPR, and PR were defined the same as outlined in the description for the primary endpoint ORR. PD was defined as outlined in the description for the endpoint PFS. K-M method was used to estimate the median DOR.
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 an OR.
reporting Status
POSTED
time Frame
Up to approximately 15.2 months
title
Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice