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NCT02561962 · OUTCOME

Time To Progression (TTP) 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

TTP was the time from the first administration of AMG 224 to the first objective assessment of disease progression as per IMWG-URC or deaths or if applicable date of censoring. The median TTP 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 A74.9Not reported3.5NAToo few events to estimate the upper 80% confidence interval (CI)
Dose Exploration: AMG 224 Dose B1.6Not reported0.7NAToo few events to estimate the upper 80% CI
Dose Exploration: AMG 224 Dose C1.4Not reported0.8NAToo few events to estimate the upper 80% CI
Dose Exploration: AMG 224 Dose D3.7Not reported2.1NAToo few events to estimate the upper 80% CI
Dose Exploration: AMG 224 Dose E14.0Not reported11.6NAToo few events to estimate the upper 80% CI
Dose Exploration: AMG 224 Dose F2.3Not reported1.46.0Not reported
Dose Exploration: AMG 224 Dose G2.8Not reported0.7NAToo few events to estimate the upper 80% CI
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment7.2Not reported0.712.3Not reported
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment4.4Not reported0.3NAToo few events to estimate the upper 80% CI
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Too few events to estimate the upper 80% confidence interval (CI)
        group Id
        OG000
        lower Limit
        3.5
        upper Limit
        NA
        value
        74.9
      2. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG001
        lower Limit
        0.7
        upper Limit
        NA
        value
        1.6
      3. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG002
        lower Limit
        0.8
        upper Limit
        NA
        value
        1.4
      4. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG003
        lower Limit
        2.1
        upper Limit
        NA
        value
        3.7
      5. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG004
        lower Limit
        11.6
        upper Limit
        NA
        value
        14.0
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        6.0
        value
        2.3
      7. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG006
        lower Limit
        0.7
        upper Limit
        NA
        value
        2.8
      8. group Id
        OG007
        lower Limit
        0.7
        upper Limit
        12.3
        value
        7.2
      9. comment
        Too few events to estimate the upper 80% CI
        group Id
        OG008
        lower Limit
        0.3
        upper Limit
        NA
        value
        4.4
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
TTP was the time from the first administration of AMG 224 to the first objective assessment of disease progression as per IMWG-URC or deaths or if applicable date of censoring. The median TTP 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
Time To Progression (TTP) According to IMWG-URC
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice