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NCT03836053 · OUTCOME

Duration of Response (DOR)

Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2025-09-11

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 3 years

What was measured

DOR was defined as number of months between first objective response to progressive disease or death (due to any cause), whichever occurred first. Kaplan-Meier methods were used to estimate the distribution of DOR. The median and corresponding two-sided 95% confidence intervals were calculated.

Analysis population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420. DOR was only calculated for participants who experienced a best overall response of partial response or better.

Groups in this outcome

AMG 420 200 µg/Day

28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

AMG 420 400 µg/Day

28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

AMG 420 600 µg/Day

28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation

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

Analysis denominator · Participants

GroupSource count
AMG 420 200 µg/Day0
AMG 420 400 µg/Day5
AMG 420 600 µg/Day3

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AMG 420 400 µg/Day5.49Not reported1.41NANot enough responses to calculate upper limit of 95% CI
AMG 420 600 µg/DayNANot reported1.45NANot enough responses to calculate a median or upper limit of 95% CI
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not enough responses to calculate upper limit of 95% CI
        group Id
        OG001
        lower Limit
        1.41
        upper Limit
        NA
        value
        5.49
      2. comment
        Not enough responses to calculate a median or upper limit of 95% CI
        group Id
        OG002
        lower Limit
        1.45
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      3
    units
    Participants
description
DOR was defined as number of months between first objective response to progressive disease or death (due to any cause), whichever occurred first. Kaplan-Meier methods were used to estimate the distribution of DOR. The median and corresponding two-sided 95% confidence intervals were calculated.
dispersion Type
95% Confidence Interval
groups
  1. description
    28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    OG000
    title
    AMG 420 200 µg/Day
  2. description
    28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    OG001
    title
    AMG 420 400 µg/Day
  3. description
    28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
    id
    OG002
    title
    AMG 420 600 µg/Day
param Type
MEDIAN
population Description
Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420. DOR was only calculated for participants who experienced a best overall response of partial response or better.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice