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NCT03836053 · OUTCOME

Overall Response Rate (ORR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 3 years

What was measured

ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (CR), CR, very good partial response (PR), or partial response as determined by the IMWG Uniform Response Criteria. The ORR along with the associated 95% exact binomial confidence interval (Clopper Pearson Method) was determined.

Analysis population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.

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/Day1
AMG 420 400 µg/Day12
AMG 420 600 µg/Day10

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AMG 420 200 µg/Day0Not reported0.0097.50Not reported
AMG 420 400 µg/Day41.7Not reported15.1772.33Not reported
AMG 420 600 µg/Day30.0Not reported6.6765.25Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0
      2. group Id
        OG001
        lower Limit
        15.17
        upper Limit
        72.33
        value
        41.7
      3. group Id
        OG002
        lower Limit
        6.67
        upper Limit
        65.25
        value
        30.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      10
    units
    Participants
description
ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (CR), CR, very good partial response (PR), or partial response as determined by the IMWG Uniform Response Criteria. The ORR along with the associated 95% exact binomial confidence interval (Clopper Pearson Method) was determined.
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
NUMBER
population Description
Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice