Skip to content
← Full study record

NCT02561962 · OUTCOME

Maximum Observed Concentration (Cmax) of AMG 224 Conjugated Antibody, Total Anti-B-cell Maturation Antigen (Anti-BCMA) Antibody, and Total Unconjugated DM1

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
MEAN
Unit
µg/mL
Interval / dispersion
Full Range
Time frame
AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, end of infusion (EOI), 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)

What was measured

Cmax of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured. DM1 is a semi-synthetic derivative of the ansamycin antibiotic, maytansine conjugated to the non-cleavable linker 4-\[N-maleimidomethyl\] cyclohexane-1-carboxylate conjugated to lysine residues in the antibody (MCC).

Analysis population: The pharmacokinetic (PK) parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated.

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 3 mg/kg

All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (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 E5
Dose Exploration: AMG 224 Dose F6
Dose Exploration: AMG 224 Dose G5
Dose Expansion: AMG 224 3 mg/kg10

Reported measurements

AMG 224 Conjugated Antibody after Cycle 1

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 E5
Dose Exploration: AMG 224 Dose F5
Dose Exploration: AMG 224 Dose G5
Dose Expansion: AMG 224 3 mg/kg10
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A11.4Not reported5.9914.3Not reported
Dose Exploration: AMG 224 Dose B22.0Not reported16.428.9Not reported
Dose Exploration: AMG 224 Dose C25.3Not reported20.031.2Not reported
Dose Exploration: AMG 224 Dose D32.9Not reported19.842.9Not reported
Dose Exploration: AMG 224 Dose E37.5Not reported6.3267.7Not reported
Dose Exploration: AMG 224 Dose F54.2Not reported45.174.4Not reported
Dose Exploration: AMG 224 Dose G61.9Not reported47.175.5Not reported
Dose Expansion: AMG 224 3 mg/kg55.8Not reported39.980.9Not reported
AMG 224 Conjugated Antibody after Cycle 2

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 E3
Dose Exploration: AMG 224 Dose F5
Dose Exploration: AMG 224 Dose G2
Dose Expansion: AMG 224 3 mg/kg8
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A11.5Not reported8.2615.4Not reported
Dose Exploration: AMG 224 Dose B29.3Not reported20.644.6Not reported
Dose Exploration: AMG 224 Dose C31.0Not reported26.439.0Not reported
Dose Exploration: AMG 224 Dose D38.5Not reported24.051.5Not reported
Dose Exploration: AMG 224 Dose E40.1Not reported29.053.8Not reported
Dose Exploration: AMG 224 Dose F60.8Not reported51.284.7Not reported
Dose Exploration: AMG 224 Dose G78.7Not reported67.489.9Not reported
Dose Expansion: AMG 224 3 mg/kg73.3Not reported46.689.9Not reported
Total Anti-BCMA Antibody after Cycle 1

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 E5
Dose Exploration: AMG 224 Dose F5
Dose Exploration: AMG 224 Dose G5
Dose Expansion: AMG 224 3 mg/kg10
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A11.9Not reported7.0914.5Not reported
Dose Exploration: AMG 224 Dose B23.9Not reported20.430.5Not reported
Dose Exploration: AMG 224 Dose C25.3Not reported21.429.8Not reported
Dose Exploration: AMG 224 Dose D34.7Not reported19.347.2Not reported
Dose Exploration: AMG 224 Dose E40.2Not reported8.7275.8Not reported
Dose Exploration: AMG 224 Dose F52.4Not reported49.655.5Not reported
Dose Exploration: AMG 224 Dose G67.7Not reported50.484.9Not reported
Dose Expansion: AMG 224 3 mg/kg52.1Not reported33.773.8Not reported
Total Anti-BCMA Antibody after Cycle 2

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 E5
Dose Exploration: AMG 224 Dose F5
Dose Exploration: AMG 224 Dose G2
Dose Expansion: AMG 224 3 mg/kg8
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A11.9Not reported9.8413.5Not reported
Dose Exploration: AMG 224 Dose B34.6Not reported22.551.8Not reported
Dose Exploration: AMG 224 Dose C33.2Not reported28.940.5Not reported
Dose Exploration: AMG 224 Dose D41.6Not reported25.056.2Not reported
Dose Exploration: AMG 224 Dose E45.3Not reported34.663.9Not reported
Dose Exploration: AMG 224 Dose F63.4Not reported55.572.4Not reported
Dose Exploration: AMG 224 Dose G79.6Not reported50.2109Not reported
Dose Expansion: AMG 224 3 mg/kg62.4Not reported39.077.2Not reported
DM1 after Cycle 1

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 E5
Dose Exploration: AMG 224 Dose F6
Dose Exploration: AMG 224 Dose G5
Dose Expansion: AMG 224 3 mg/kg10
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A0.00Not reported0.000.00Not reported
Dose Exploration: AMG 224 Dose B0.00Not reported0.000.00Not reported
Dose Exploration: AMG 224 Dose C0.000312Not reported0.000.000501Not reported
Dose Exploration: AMG 224 Dose D0.000549Not reported0.0004450.000693Not reported
Dose Exploration: AMG 224 Dose E0.00131Not reported0.0005680.00210Not reported
Dose Exploration: AMG 224 Dose F0.00141Not reported0.0009670.00192Not reported
Dose Exploration: AMG 224 Dose G0.00155Not reported0.001230.00201Not reported
Dose Expansion: AMG 224 3 mg/kg0.00149Not reported0.0009240.00210Not reported
DM1 after Cycle 2

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 E3
Dose Exploration: AMG 224 Dose F5
Dose Exploration: AMG 224 Dose G2
Dose Expansion: AMG 224 3 mg/kg8
Values in µg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Exploration: AMG 224 Dose A0.00Not reported0.000.00Not reported
Dose Exploration: AMG 224 Dose B0.000119Not reported0.000.000356Not reported
Dose Exploration: AMG 224 Dose C0.000414Not reported0.0002970.000590Not reported
Dose Exploration: AMG 224 Dose D0.000654Not reported0.0004230.000913Not reported
Dose Exploration: AMG 224 Dose E0.000872Not reported0.0006580.00121Not reported
Dose Exploration: AMG 224 Dose F0.00172Not reported0.001410.00264Not reported
Dose Exploration: AMG 224 Dose G0.00161Not reported0.001510.00170Not reported
Dose Expansion: AMG 224 3 mg/kg0.00177Not reported0.001400.00242Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.99
        upper Limit
        14.3
        value
        11.4
      2. group Id
        OG001
        lower Limit
        16.4
        upper Limit
        28.9
        value
        22.0
      3. group Id
        OG002
        lower Limit
        20.0
        upper Limit
        31.2
        value
        25.3
      4. group Id
        OG003
        lower Limit
        19.8
        upper Limit
        42.9
        value
        32.9
      5. group Id
        OG004
        lower Limit
        6.32
        upper Limit
        67.7
        value
        37.5
      6. group Id
        OG005
        lower Limit
        45.1
        upper Limit
        74.4
        value
        54.2
      7. group Id
        OG006
        lower Limit
        47.1
        upper Limit
        75.5
        value
        61.9
      8. group Id
        OG007
        lower Limit
        39.9
        upper Limit
        80.9
        value
        55.8
    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
        5
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    AMG 224 Conjugated Antibody after Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.26
        upper Limit
        15.4
        value
        11.5
      2. group Id
        OG001
        lower Limit
        20.6
        upper Limit
        44.6
        value
        29.3
      3. group Id
        OG002
        lower Limit
        26.4
        upper Limit
        39.0
        value
        31.0
      4. group Id
        OG003
        lower Limit
        24.0
        upper Limit
        51.5
        value
        38.5
      5. group Id
        OG004
        lower Limit
        29.0
        upper Limit
        53.8
        value
        40.1
      6. group Id
        OG005
        lower Limit
        51.2
        upper Limit
        84.7
        value
        60.8
      7. group Id
        OG006
        lower Limit
        67.4
        upper Limit
        89.9
        value
        78.7
      8. group Id
        OG007
        lower Limit
        46.6
        upper Limit
        89.9
        value
        73.3
    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
        3
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    AMG 224 Conjugated Antibody after Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.09
        upper Limit
        14.5
        value
        11.9
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        30.5
        value
        23.9
      3. group Id
        OG002
        lower Limit
        21.4
        upper Limit
        29.8
        value
        25.3
      4. group Id
        OG003
        lower Limit
        19.3
        upper Limit
        47.2
        value
        34.7
      5. group Id
        OG004
        lower Limit
        8.72
        upper Limit
        75.8
        value
        40.2
      6. group Id
        OG005
        lower Limit
        49.6
        upper Limit
        55.5
        value
        52.4
      7. group Id
        OG006
        lower Limit
        50.4
        upper Limit
        84.9
        value
        67.7
      8. group Id
        OG007
        lower Limit
        33.7
        upper Limit
        73.8
        value
        52.1
    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
        5
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    Total Anti-BCMA Antibody after Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.84
        upper Limit
        13.5
        value
        11.9
      2. group Id
        OG001
        lower Limit
        22.5
        upper Limit
        51.8
        value
        34.6
      3. group Id
        OG002
        lower Limit
        28.9
        upper Limit
        40.5
        value
        33.2
      4. group Id
        OG003
        lower Limit
        25.0
        upper Limit
        56.2
        value
        41.6
      5. group Id
        OG004
        lower Limit
        34.6
        upper Limit
        63.9
        value
        45.3
      6. group Id
        OG005
        lower Limit
        55.5
        upper Limit
        72.4
        value
        63.4
      7. group Id
        OG006
        lower Limit
        50.2
        upper Limit
        109
        value
        79.6
      8. group Id
        OG007
        lower Limit
        39.0
        upper Limit
        77.2
        value
        62.4
    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
        5
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    Total Anti-BCMA Antibody after Cycle 2
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.00
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        0.000501
        value
        0.000312
      4. group Id
        OG003
        lower Limit
        0.000445
        upper Limit
        0.000693
        value
        0.000549
      5. group Id
        OG004
        lower Limit
        0.000568
        upper Limit
        0.00210
        value
        0.00131
      6. group Id
        OG005
        lower Limit
        0.000967
        upper Limit
        0.00192
        value
        0.00141
      7. group Id
        OG006
        lower Limit
        0.00123
        upper Limit
        0.00201
        value
        0.00155
      8. group Id
        OG007
        lower Limit
        0.000924
        upper Limit
        0.00210
        value
        0.00149
    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
        5
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    DM1 after Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        0.000356
        value
        0.000119
      3. group Id
        OG002
        lower Limit
        0.000297
        upper Limit
        0.000590
        value
        0.000414
      4. group Id
        OG003
        lower Limit
        0.000423
        upper Limit
        0.000913
        value
        0.000654
      5. group Id
        OG004
        lower Limit
        0.000658
        upper Limit
        0.00121
        value
        0.000872
      6. group Id
        OG005
        lower Limit
        0.00141
        upper Limit
        0.00264
        value
        0.00172
      7. group Id
        OG006
        lower Limit
        0.00151
        upper Limit
        0.00170
        value
        0.00161
      8. group Id
        OG007
        lower Limit
        0.00140
        upper Limit
        0.00242
        value
        0.00177
    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
        3
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    DM1 after Cycle 2
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
      5
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      10
    units
    Participants
description
Cmax of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured. DM1 is a semi-synthetic derivative of the ansamycin antibiotic, maytansine conjugated to the non-cleavable linker 4-\[N-maleimidomethyl\] cyclohexane-1-carboxylate conjugated to lysine residues in the antibody (MCC).
dispersion Type
Full Range
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
    All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    OG007
    title
    Dose Expansion: AMG 224 3 mg/kg
param Type
MEAN
population Description
The pharmacokinetic (PK) parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated.
reporting Status
POSTED
time Frame
AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, end of infusion (EOI), 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)
title
Maximum Observed Concentration (Cmax) of AMG 224 Conjugated Antibody, Total Anti-B-cell Maturation Antigen (Anti-BCMA) Antibody, and Total Unconjugated DM1
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice