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NCT02561962 · OUTCOME

Area Under the Concentration-time Curve (AUC) of AMG 224 Conjugated Antibody, Total 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: h*µg/mL
Interval / dispersion: Full Range
Time frame: AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycle 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)

What was measured

AUC from time zero to 3 weeks (AUC(3 weeks)) was determined for AMG 224 conjugated antibody and total anti-BCMA antibody, and AUC from time zero to 96 hours (AUC(0-96hr)) was determined for DM1.

Analysis population: The PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated. All participants included in the overall number of participants analyzed contributed data to this endpoint.

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

Group	Source count
Dose Exploration: AMG 224 Dose A	3
Dose Exploration: AMG 224 Dose B	3
Dose Exploration: AMG 224 Dose C	3
Dose Exploration: AMG 224 Dose D	3
Dose Exploration: AMG 224 Dose E	5
Dose Exploration: AMG 224 Dose F	6
Dose Exploration: AMG 224 Dose G	4
Dose Expansion: AMG 224 3 mg/kg	8

Reported measurements

AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 1

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	3
Dose Exploration: AMG 224 Dose B	3
Dose Exploration: AMG 224 Dose C	3
Dose Exploration: AMG 224 Dose D	3
Dose Exploration: AMG 224 Dose E	5
Dose Exploration: AMG 224 Dose F	5
Dose Exploration: AMG 224 Dose G	2
Dose Expansion: AMG 224 3 mg/kg	8

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	1850	Not reported	1240	2560	Not reported
Dose Exploration: AMG 224 Dose B	3450	Not reported	2870	4240	Not reported
Dose Exploration: AMG 224 Dose C	4520	Not reported	3910	4950	Not reported
Dose Exploration: AMG 224 Dose D	5260	Not reported	2750	7570	Not reported
Dose Exploration: AMG 224 Dose E	3710	Not reported	1590	4970	Not reported
Dose Exploration: AMG 224 Dose F	10400	Not reported	9040	14300	Not reported
Dose Exploration: AMG 224 Dose G	10500	Not reported	7060	14000	Not reported
Dose Expansion: AMG 224 3 mg/kg	9690	Not reported	5620	14000	Not reported

AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 2

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	3
Dose Exploration: AMG 224 Dose B	2
Dose Exploration: AMG 224 Dose C	3
Dose Exploration: AMG 224 Dose D	3
Dose Exploration: AMG 224 Dose E	3
Dose Exploration: AMG 224 Dose F	3
Dose Exploration: AMG 224 Dose G	1
Dose Expansion: AMG 224 3 mg/kg	7

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	2330	Not reported	1340	2900	Not reported
Dose Exploration: AMG 224 Dose B	3650	Not reported	3460	3840	Not reported
Dose Exploration: AMG 224 Dose C	6360	Not reported	5820	7250	Not reported
Dose Exploration: AMG 224 Dose D	7400	Not reported	4000	9640	Not reported
Dose Exploration: AMG 224 Dose E	7610	Not reported	4250	12400	Not reported
Dose Exploration: AMG 224 Dose F	14100	Not reported	13100	15100	Not reported
Dose Exploration: AMG 224 Dose G	23000	Not reported	23000	23000	Not reported
Dose Expansion: AMG 224 3 mg/kg	15500	Not reported	10100	20800	Not reported

AUC(3weeks): Total Anti-BCMA Antibody after Cycle 1

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	3
Dose Exploration: AMG 224 Dose B	3
Dose Exploration: AMG 224 Dose C	3
Dose Exploration: AMG 224 Dose D	3
Dose Exploration: AMG 224 Dose E	3
Dose Exploration: AMG 224 Dose F	5
Dose Exploration: AMG 224 Dose G	2
Dose Expansion: AMG 224 3 mg/kg	8

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	1990	Not reported	1300	2690	Not reported
Dose Exploration: AMG 224 Dose B	3850	Not reported	3300	4450	Not reported
Dose Exploration: AMG 224 Dose C	5120	Not reported	4540	5910	Not reported
Dose Exploration: AMG 224 Dose D	5870	Not reported	3160	8110	Not reported
Dose Exploration: AMG 224 Dose E	4220	Not reported	2200	5440	Not reported
Dose Exploration: AMG 224 Dose F	11300	Not reported	10400	12500	Not reported
Dose Exploration: AMG 224 Dose G	11200	Not reported	6140	16200	Not reported
Dose Expansion: AMG 224 3 mg/kg	8680	Not reported	6640	11400	Not reported

AUC(3weeks): Total Anti-BCMA Antibody after Cycle 2

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	3
Dose Exploration: AMG 224 Dose B	2
Dose Exploration: AMG 224 Dose C	3
Dose Exploration: AMG 224 Dose D	3
Dose Exploration: AMG 224 Dose E	3
Dose Exploration: AMG 224 Dose F	3
Dose Exploration: AMG 224 Dose G	1
Dose Expansion: AMG 224 3 mg/kg	7

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	2530	Not reported	1460	3310	Not reported
Dose Exploration: AMG 224 Dose B	4370	Not reported	4180	4560	Not reported
Dose Exploration: AMG 224 Dose C	8140	Not reported	7140	10100	Not reported
Dose Exploration: AMG 224 Dose D	9170	Not reported	4660	13200	Not reported
Dose Exploration: AMG 224 Dose E	9250	Not reported	4900	16100	Not reported
Dose Exploration: AMG 224 Dose F	18500	Not reported	17400	20500	Not reported
Dose Exploration: AMG 224 Dose G	24700	Not reported	24700	24700	Not reported
Dose Expansion: AMG 224 3 mg/kg	13000	Not reported	8880	18600	Not reported

AUC(0-96hr): DM1 after Cycle 1

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	0
Dose Exploration: AMG 224 Dose B	0
Dose Exploration: AMG 224 Dose C	0
Dose Exploration: AMG 224 Dose D	0
Dose Exploration: AMG 224 Dose E	1
Dose Exploration: AMG 224 Dose F	5
Dose Exploration: AMG 224 Dose G	3
Dose Expansion: AMG 224 3 mg/kg	4

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose E	0.0729	Not reported	0.0729	0.0729	Not reported
Dose Exploration: AMG 224 Dose F	0.0487	Not reported	0.0328	0.0597	Not reported
Dose Exploration: AMG 224 Dose G	0.0579	Not reported	0.0421	0.0668	Not reported
Dose Expansion: AMG 224 3 mg/kg	0.0646	Not reported	0.0426	0.0743	Not reported

AUC(0-96hr): DM1 after Cycle 2

Analysis denominator · Participants

Group	Source count
Dose Exploration: AMG 224 Dose A	0
Dose Exploration: AMG 224 Dose B	0
Dose Exploration: AMG 224 Dose C	0
Dose Exploration: AMG 224 Dose D	0
Dose Exploration: AMG 224 Dose E	1
Dose Exploration: AMG 224 Dose F	5
Dose Exploration: AMG 224 Dose G	1
Dose Expansion: AMG 224 3 mg/kg	7

Values in h*µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose E	0.0561	Not reported	0.0561	0.0561	Not reported
Dose Exploration: AMG 224 Dose F	0.0654	Not reported	0.0484	0.0770	Not reported
Dose Exploration: AMG 224 Dose G	0.0684	Not reported	0.0684	0.0684	Not reported
Dose Expansion: AMG 224 3 mg/kg	0.0688	Not reported	0.0588	0.0865	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1240
upper Limit
2560
value
1850
group Id
OG001
lower Limit
2870
upper Limit
4240
value
3450
group Id
OG002
lower Limit
3910
upper Limit
4950
value
4520
group Id
OG003
lower Limit
2750
upper Limit
7570
value
5260
group Id
OG004
lower Limit
1590
upper Limit
4970
value
3710
group Id
OG005
lower Limit
9040
upper Limit
14300
value
10400
group Id
OG006
lower Limit
7060
upper Limit
14000
value
10500
group Id
OG007
lower Limit
5620
upper Limit
14000
value
9690
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
5
group Id
OG005
value
5
group Id
OG006
value
2
group Id
OG007
value
8
units
Participants
title
AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 1
categories
measurements
group Id
OG000
lower Limit
1340
upper Limit
2900
value
2330
group Id
OG001
lower Limit
3460
upper Limit
3840
value
3650
group Id
OG002
lower Limit
5820
upper Limit
7250
value
6360
group Id
OG003
lower Limit
4000
upper Limit
9640
value
7400
group Id
OG004
lower Limit
4250
upper Limit
12400
value
7610
group Id
OG005
lower Limit
13100
upper Limit
15100
value
14100
group Id
OG006
lower Limit
23000
upper Limit
23000
value
23000
group Id
OG007
lower Limit
10100
upper Limit
20800
value
15500
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
1
group Id
OG007
value
7
units
Participants
title
AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 2
categories
measurements
group Id
OG000
lower Limit
1300
upper Limit
2690
value
1990
group Id
OG001
lower Limit
3300
upper Limit
4450
value
3850
group Id
OG002
lower Limit
4540
upper Limit
5910
value
5120
group Id
OG003
lower Limit
3160
upper Limit
8110
value
5870
group Id
OG004
lower Limit
2200
upper Limit
5440
value
4220
group Id
OG005
lower Limit
10400
upper Limit
12500
value
11300
group Id
OG006
lower Limit
6140
upper Limit
16200
value
11200
group Id
OG007
lower Limit
6640
upper Limit
11400
value
8680
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
5
group Id
OG006
value
2
group Id
OG007
value
8
units
Participants
title
AUC(3weeks): Total Anti-BCMA Antibody after Cycle 1
categories
measurements
group Id
OG000
lower Limit
1460
upper Limit
3310
value
2530
group Id
OG001
lower Limit
4180
upper Limit
4560
value
4370
group Id
OG002
lower Limit
7140
upper Limit
10100
value
8140
group Id
OG003
lower Limit
4660
upper Limit
13200
value
9170
group Id
OG004
lower Limit
4900
upper Limit
16100
value
9250
group Id
OG005
lower Limit
17400
upper Limit
20500
value
18500
group Id
OG006
lower Limit
24700
upper Limit
24700
value
24700
group Id
OG007
lower Limit
8880
upper Limit
18600
value
13000
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
1
group Id
OG007
value
7
units
Participants
title
AUC(3weeks): Total Anti-BCMA Antibody after Cycle 2
categories
measurements
group Id
OG004
lower Limit
0.0729
upper Limit
0.0729
value
0.0729
group Id
OG005
lower Limit
0.0328
upper Limit
0.0597
value
0.0487
group Id
OG006
lower Limit
0.0421
upper Limit
0.0668
value
0.0579
group Id
OG007
lower Limit
0.0426
upper Limit
0.0743
value
0.0646
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
5
group Id
OG006
value
3
group Id
OG007
value
4
units
Participants
title
AUC(0-96hr): DM1 after Cycle 1
categories
measurements
group Id
OG004
lower Limit
0.0561
upper Limit
0.0561
value
0.0561
group Id
OG005
lower Limit
0.0484
upper Limit
0.0770
value
0.0654
group Id
OG006
lower Limit
0.0684
upper Limit
0.0684
value
0.0684
group Id
OG007
lower Limit
0.0588
upper Limit
0.0865
value
0.0688
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
5
group Id
OG006
value
1
group Id
OG007
value
7
units
Participants
title
AUC(0-96hr): DM1 after Cycle 2

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
5
group Id
OG005
value
6
group Id
OG006
value
4
group Id
OG007
value
8
units
Participants

description

AUC from time zero to 3 weeks (AUC(3 weeks)) was determined for AMG 224 conjugated antibody and total anti-BCMA antibody, and AUC from time zero to 96 hours (AUC(0-96hr)) was determined for DM1.

dispersion Type

Full Range

groups

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
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
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
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
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
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
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
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 PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated. All participants included in the overall number of participants analyzed contributed data to this endpoint.

reporting Status

POSTED

time Frame

AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycle 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)

title

Area Under the Concentration-time Curve (AUC) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1

type

SECONDARY

unit Of Measure

h*µg/mL

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

Preserved source evidence · Not medical advice