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NCT02561962 · OUTCOME

Duration of Response (DOR) According to IMWG-URC

A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-02-01

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

Measure
MEDIAN
Unit
months
Interval / dispersion
80% Confidence Interval
Time frame
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years

What was measured

DOR was defined as the time between the date of the first observation indicating an objective response as PR (or better) through to the subsequent date of disease progression as classified by the IMWG-URC for Multiple Myeloma or death or where applicable date of censoring. The median DOR was estimated using the Kaplan-Meier method.

Analysis population: The safety analysis set included all participants who received at least 1 dose of AMG 224.

Groups in this outcome

Dose Exploration: AMG 224 Dose A

Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose B

Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose C

Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose D

Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose E

Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose F

Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Exploration: AMG 224 Dose G

Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment

Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment

Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.

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

Analysis denominator · Participants

GroupSource count
Dose Exploration: AMG 224 Dose A3
Dose Exploration: AMG 224 Dose B3
Dose Exploration: AMG 224 Dose C3
Dose Exploration: AMG 224 Dose D3
Dose Exploration: AMG 224 Dose E6
Dose Exploration: AMG 224 Dose F6
Dose Exploration: AMG 224 Dose G5
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment9
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment2

Reported measurements

Source class 1
Values in months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A63.1Not reportedNANAToo few events to estimate the 80% CIs
Dose Exploration: AMG 224 Dose BNANot reportedNANANo events therefore median and 80% CIs could not be estimated
Dose Exploration: AMG 224 Dose CNANot reportedNANANo events therefore median and 80% CIs could not be estimated
Dose Exploration: AMG 224 Dose D60.8Not reportedNANAToo few events to estimate the 80% CIs
Dose Exploration: AMG 224 Dose E9.1Not reported8.1NAToo few events to estimate the upper 80% CI
Dose Exploration: AMG 224 Dose F19.2Not reportedNANAToo few events to estimate the 80% CIs
Dose Exploration: AMG 224 Dose G4.1Not reportedNANAToo few events to estimate the 80% CIs
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment18.7Not reported6.7NAToo few events to estimate the upper 80% CI
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment7.7Not reportedNANAToo few events to estimate the 80% CIs
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Too few events to estimate the 80% CIs
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        63.1
      2. comment
        No events therefore median and 80% CIs could not be estimated
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        No events therefore median and 80% CIs could not be estimated
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Too few events to estimate the 80% CIs
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        60.8
      5. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG004
        lower Limit
        8.1
        upper Limit
        NA
        value
        9.1
      6. comment
        Too few events to estimate the 80% CIs
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        19.2
      7. comment
        Too few events to estimate the 80% CIs
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        4.1
      8. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG007
        lower Limit
        6.7
        upper Limit
        NA
        value
        18.7
      9. comment
        Too few events to estimate the 80% CIs
        group Id
        OG008
        lower Limit
        NA
        upper Limit
        NA
        value
        7.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      2
    units
    Participants
description
DOR was defined as the time between the date of the first observation indicating an objective response as PR (or better) through to the subsequent date of disease progression as classified by the IMWG-URC for Multiple Myeloma or death or where applicable date of censoring. The median DOR was estimated using the Kaplan-Meier method.
dispersion Type
80% Confidence Interval
groups
  1. description
    Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG000
    title
    Dose Exploration: AMG 224 Dose A
  2. description
    Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG001
    title
    Dose Exploration: AMG 224 Dose B
  3. description
    Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG002
    title
    Dose Exploration: AMG 224 Dose C
  4. description
    Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG003
    title
    Dose Exploration: AMG 224 Dose D
  5. description
    Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG004
    title
    Dose Exploration: AMG 224 Dose E
  6. description
    Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG005
    title
    Dose Exploration: AMG 224 Dose F
  7. description
    Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG006
    title
    Dose Exploration: AMG 224 Dose G
  8. description
    Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG007
    title
    Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
  9. description
    Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG008
    title
    Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
param Type
MEDIAN
population Description
The safety analysis set included all participants who received at least 1 dose of AMG 224.
reporting Status
POSTED
time Frame
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
title
Duration of Response (DOR) According to IMWG-URC
type
SECONDARY
unit Of Measure
months

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