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NCT02561962 · OUTCOME

Minimum Observed Concentration (Cmin) 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: 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 (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

Cmin of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured.

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.

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	5
Dose Expansion: AMG 224 3 mg/kg	10

Reported measurements

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 µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	1.45	Not reported	0.970	1.71	Not reported
Dose Exploration: AMG 224 Dose B	2.81	Not reported	2.11	4.05	Not reported
Dose Exploration: AMG 224 Dose C	4.54	Not reported	3.70	5.46	Not reported
Dose Exploration: AMG 224 Dose D	4.40	Not reported	1.69	8.80	Not reported
Dose Exploration: AMG 224 Dose E	3.51	Not reported	2.11	6.32	Not reported
Dose Exploration: AMG 224 Dose F	10.5	Not reported	5.75	18.2	Not reported
Dose Exploration: AMG 224 Dose G	9.29	Not reported	3.87	14.7	Not reported
Dose Expansion: AMG 224 3 mg/kg	10.6	Not reported	3.65	16.6	Not reported

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	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 µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	1.51	Not reported	0.811	1.93	Not reported
Dose Exploration: AMG 224 Dose B	3.06	Not reported	2.44	4.05	Not reported
Dose Exploration: AMG 224 Dose C	6.71	Not reported	5.97	7.99	Not reported
Dose Exploration: AMG 224 Dose D	5.91	Not reported	3.33	10.1	Not reported
Dose Exploration: AMG 224 Dose E	6.64	Not reported	1.91	12.0	Not reported
Dose Exploration: AMG 224 Dose F	15.2	Not reported	5.75	20.4	Not reported
Dose Exploration: AMG 224 Dose G	20.0	Not reported	3.87	36.2	Not reported
Dose Expansion: AMG 224 3 mg/kg	15.9	Not reported	4.68	27.7	Not reported

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 µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	1.70	Not reported	1.05	2.07	Not reported
Dose Exploration: AMG 224 Dose B	3.91	Not reported	2.56	5.83	Not reported
Dose Exploration: AMG 224 Dose C	6.69	Not reported	5.52	8.27	Not reported
Dose Exploration: AMG 224 Dose D	5.50	Not reported	2.78	9.87	Not reported
Dose Exploration: AMG 224 Dose E	4.86	Not reported	2.86	8.72	Not reported
Dose Exploration: AMG 224 Dose F	13.5	Not reported	8.14	17.5	Not reported
Dose Exploration: AMG 224 Dose G	10.9	Not reported	3.47	18.3	Not reported
Dose Expansion: AMG 224 3 mg/kg	9.47	Not reported	3.76	15.1	Not reported

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	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 µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	2.25	Not reported	1.25	2.78	Not reported
Dose Exploration: AMG 224 Dose B	4.62	Not reported	3.78	5.83	Not reported
Dose Exploration: AMG 224 Dose C	11.9	Not reported	10.2	14.7	Not reported
Dose Exploration: AMG 224 Dose D	10.1	Not reported	4.24	19.1	Not reported
Dose Exploration: AMG 224 Dose E	11.3	Not reported	3.72	21.0	Not reported
Dose Exploration: AMG 224 Dose F	21.8	Not reported	8.14	33.6	Not reported
Dose Exploration: AMG 224 Dose G	15.4	Not reported	3.47	27.4	Not reported
Dose Expansion: AMG 224 3 mg/kg	13.1	Not reported	4.56	23.7	Not reported

DM1 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	4
Dose Exploration: AMG 224 Dose F	6
Dose Exploration: AMG 224 Dose G	5
Dose Expansion: AMG 224 3 mg/kg	10

Values in µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose B	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose C	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose D	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose E	0.000160	Not reported	0.00	0.000341	Not reported
Dose Exploration: AMG 224 Dose F	0.000268	Not reported	0.00	0.000353	Not reported
Dose Exploration: AMG 224 Dose G	0.000206	Not reported	0.00	0.000408	Not reported
Dose Expansion: AMG 224 3 mg/kg	0.000189	Not reported	0.00	0.000694	Not reported

DM1 after Cycle 2

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	2
Dose Exploration: AMG 224 Dose F	5
Dose Exploration: AMG 224 Dose G	2
Dose Expansion: AMG 224 3 mg/kg	8

Values in µg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Dose Exploration: AMG 224 Dose A	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose B	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose C	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose D	0.00	Not reported	0.00	0.00	Not reported
Dose Exploration: AMG 224 Dose E	0.000150	Not reported	0.00	0.000300	Not reported
Dose Exploration: AMG 224 Dose F	0.000468	Not reported	0.000443	0.000535	Not reported
Dose Exploration: AMG 224 Dose G	0.000254	Not reported	0.00	0.000507	Not reported
Dose Expansion: AMG 224 3 mg/kg	0.000494	Not reported	0.000364	0.000796	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.970
upper Limit
1.71
value
1.45
group Id
OG001
lower Limit
2.11
upper Limit
4.05
value
2.81
group Id
OG002
lower Limit
3.70
upper Limit
5.46
value
4.54
group Id
OG003
lower Limit
1.69
upper Limit
8.80
value
4.40
group Id
OG004
lower Limit
2.11
upper Limit
6.32
value
3.51
group Id
OG005
lower Limit
5.75
upper Limit
18.2
value
10.5
group Id
OG006
lower Limit
3.87
upper Limit
14.7
value
9.29
group Id
OG007
lower Limit
3.65
upper Limit
16.6
value
10.6
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
AMG 224 Conjugated Antibody after Cycle 1
categories
measurements
group Id
OG000
lower Limit
0.811
upper Limit
1.93
value
1.51
group Id
OG001
lower Limit
2.44
upper Limit
4.05
value
3.06
group Id
OG002
lower Limit
5.97
upper Limit
7.99
value
6.71
group Id
OG003
lower Limit
3.33
upper Limit
10.1
value
5.91
group Id
OG004
lower Limit
1.91
upper Limit
12.0
value
6.64
group Id
OG005
lower Limit
5.75
upper Limit
20.4
value
15.2
group Id
OG006
lower Limit
3.87
upper Limit
36.2
value
20.0
group Id
OG007
lower Limit
4.68
upper Limit
27.7
value
15.9
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
AMG 224 Conjugated Antibody after Cycle 2
categories
measurements
group Id
OG000
lower Limit
1.05
upper Limit
2.07
value
1.70
group Id
OG001
lower Limit
2.56
upper Limit
5.83
value
3.91
group Id
OG002
lower Limit
5.52
upper Limit
8.27
value
6.69
group Id
OG003
lower Limit
2.78
upper Limit
9.87
value
5.50
group Id
OG004
lower Limit
2.86
upper Limit
8.72
value
4.86
group Id
OG005
lower Limit
8.14
upper Limit
17.5
value
13.5
group Id
OG006
lower Limit
3.47
upper Limit
18.3
value
10.9
group Id
OG007
lower Limit
3.76
upper Limit
15.1
value
9.47
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
Total Anti-BCMA Antibody after Cycle 1
categories
measurements
group Id
OG000
lower Limit
1.25
upper Limit
2.78
value
2.25
group Id
OG001
lower Limit
3.78
upper Limit
5.83
value
4.62
group Id
OG002
lower Limit
10.2
upper Limit
14.7
value
11.9
group Id
OG003
lower Limit
4.24
upper Limit
19.1
value
10.1
group Id
OG004
lower Limit
3.72
upper Limit
21.0
value
11.3
group Id
OG005
lower Limit
8.14
upper Limit
33.6
value
21.8
group Id
OG006
lower Limit
3.47
upper Limit
27.4
value
15.4
group Id
OG007
lower Limit
4.56
upper Limit
23.7
value
13.1
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
Total Anti-BCMA Antibody after Cycle 2
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG001
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG002
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG003
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG004
lower Limit
0.00
upper Limit
0.000341
value
0.000160
group Id
OG005
lower Limit
0.00
upper Limit
0.000353
value
0.000268
group Id
OG006
lower Limit
0.00
upper Limit
0.000408
value
0.000206
group Id
OG007
lower Limit
0.00
upper Limit
0.000694
value
0.000189
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
4
group Id
OG005
value
6
group Id
OG006
value
5
group Id
OG007
value
10
units
Participants
title
DM1 after Cycle 1
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG001
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG002
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG003
lower Limit
0.00
upper Limit
0.00
value
0.00
group Id
OG004
lower Limit
0.00
upper Limit
0.000300
value
0.000150
group Id
OG005
lower Limit
0.000443
upper Limit
0.000535
value
0.000468
group Id
OG006
lower Limit
0.00
upper Limit
0.000507
value
0.000254
group Id
OG007
lower Limit
0.000364
upper Limit
0.000796
value
0.000494
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
2
group Id
OG005
value
5
group Id
OG006
value
2
group Id
OG007
value
8
units
Participants
title
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
5
group Id
OG007
value
10
units
Participants

description

Cmin of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured.

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.

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 (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)

title

Minimum Observed Concentration (Cmin) of AMG 224 Conjugated Antibody, Total 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