TriangleNCT02561962 · OUTCOME
Clearance (CL) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mL/hr
- 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
CL of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was determined.
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 | 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
| 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 | 5 |
| Dose Expansion: AMG 224 3 mg/kg | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 17.7 | Not reported | 11.7 | 24.2 | Not reported |
| Dose Exploration: AMG 224 Dose B | 17.9 | Not reported | 14.2 | 20.9 | Not reported |
| Dose Exploration: AMG 224 Dose C | 20.1 | Not reported | 18.2 | 23.0 | Not reported |
| Dose Exploration: AMG 224 Dose D | 27.2 | Not reported | 15.8 | 43.7 | Not reported |
| Dose Exploration: AMG 224 Dose E | 47.0 | Not reported | 28.2 | 100 | Not reported |
| Dose Exploration: AMG 224 Dose F | 18.8 | Not reported | 13.3 | 21.0 | Not reported |
| Dose Exploration: AMG 224 Dose G | 26.0 | Not reported | 17.9 | 35.4 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 26.6 | Not reported | 15.1 | 42.7 | Not reported |
AMG 224 Conjugated Antibody after Cycle 2
| 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 | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 14.5 | Not reported | 10.3 | 22.3 | Not reported |
| Dose Exploration: AMG 224 Dose B | 15.9 | Not reported | 14.8 | 17.3 | Not reported |
| Dose Exploration: AMG 224 Dose C | 14.3 | Not reported | 12.4 | 15.5 | Not reported |
| Dose Exploration: AMG 224 Dose D | 18.8 | Not reported | 12.4 | 30.0 | Not reported |
| Dose Exploration: AMG 224 Dose E | 25.5 | Not reported | 12.9 | 37.7 | Not reported |
| Dose Exploration: AMG 224 Dose F | 13.7 | Not reported | 9.13 | 18.8 | Not reported |
| Dose Exploration: AMG 224 Dose G | 20.9 | Not reported | 10.9 | 30.9 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 16.1 | Not reported | 11.2 | 22.8 | Not reported |
Total Anti-BCMA Antibody after Cycle 1
| 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 | 5 |
| Dose Expansion: AMG 224 3 mg/kg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 16.5 | Not reported | 11.1 | 23.2 | Not reported |
| Dose Exploration: AMG 224 Dose B | 15.8 | Not reported | 13.5 | 18.2 | Not reported |
| Dose Exploration: AMG 224 Dose C | 17.8 | Not reported | 15.2 | 19.8 | Not reported |
| Dose Exploration: AMG 224 Dose D | 23.9 | Not reported | 14.8 | 38.0 | Not reported |
| Dose Exploration: AMG 224 Dose E | 40.5 | Not reported | 25.7 | 72.8 | Not reported |
| Dose Exploration: AMG 224 Dose F | 16.8 | Not reported | 15.2 | 18.3 | Not reported |
| Dose Exploration: AMG 224 Dose G | 24.6 | Not reported | 15.5 | 40.7 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 26.2 | Not reported | 12.9 | 34.6 | Not reported |
Total Anti-BCMA Antibody after Cycle 2
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 13.4 | Not reported | 9.07 | 20.5 | Not reported |
| Dose Exploration: AMG 224 Dose B | 13.4 | Not reported | 12.9 | 14.3 | Not reported |
| Dose Exploration: AMG 224 Dose C | 11.4 | Not reported | 8.92 | 12.6 | Not reported |
| Dose Exploration: AMG 224 Dose D | 15.8 | Not reported | 9.10 | 25.8 | Not reported |
| Dose Exploration: AMG 224 Dose E | 22.1 | Not reported | 9.94 | 32.6 | Not reported |
| Dose Exploration: AMG 224 Dose F | 11.4 | Not reported | 9.29 | 16.2 | Not reported |
| Dose Exploration: AMG 224 Dose G | 22.4 | Not reported | 10.1 | 34.6 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 18.6 | Not reported | 11.6 | 24.8 | Not reported |
DM1 after Cycle 1
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 0 |
| Dose Exploration: AMG 224 Dose B | 0 |
| Dose Exploration: AMG 224 Dose C | 2 |
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose C | 20800000 | Not reported | 20400000 | 21300000 | Not reported |
| Dose Exploration: AMG 224 Dose D | 53300000 | Not reported | 6310000 | 131000000 | Not reported |
| Dose Exploration: AMG 224 Dose E | 9310000 | Not reported | 2190000 | 24300000 | Not reported |
| Dose Exploration: AMG 224 Dose F | 4360000 | Not reported | 3180000 | 5790000 | Not reported |
| Dose Exploration: AMG 224 Dose G | 6100000 | Not reported | 3740000 | 9350000 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 5620000 | Not reported | 2160000 | 10600000 | Not reported |
DM1 after Cycle 2
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 0 |
| Dose Exploration: AMG 224 Dose B | 1 |
| 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 | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose B | 18700000 | Not reported | 18700000 | 18700000 | Not reported |
| Dose Exploration: AMG 224 Dose C | 69800000 | Not reported | 13500000 | 173000000 | Not reported |
| Dose Exploration: AMG 224 Dose D | 11300000 | Not reported | 5860000 | 21700000 | Not reported |
| Dose Exploration: AMG 224 Dose E | 5060000 | Not reported | 2850000 | 7270000 | Not reported |
| Dose Exploration: AMG 224 Dose F | 2990000 | Not reported | 2470000 | 3930000 | Not reported |
| Dose Exploration: AMG 224 Dose G | 5970000 | Not reported | 3660000 | 8290000 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 3480000 | Not reported | 2080000 | 4960000 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.7
- upper Limit
- 24.2
- value
- 17.7
- group Id
- OG001
- lower Limit
- 14.2
- upper Limit
- 20.9
- value
- 17.9
- group Id
- OG002
- lower Limit
- 18.2
- upper Limit
- 23.0
- value
- 20.1
- group Id
- OG003
- lower Limit
- 15.8
- upper Limit
- 43.7
- value
- 27.2
- group Id
- OG004
- lower Limit
- 28.2
- upper Limit
- 100
- value
- 47.0
- group Id
- OG005
- lower Limit
- 13.3
- upper Limit
- 21.0
- value
- 18.8
- group Id
- OG006
- lower Limit
- 17.9
- upper Limit
- 35.4
- value
- 26.0
- group Id
- OG007
- lower Limit
- 15.1
- upper Limit
- 42.7
- value
- 26.6
- 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
- 5
- group Id
- OG007
- value
- 10
- units
- Participants
- title
- AMG 224 Conjugated Antibody after Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 22.3
- value
- 14.5
- group Id
- OG001
- lower Limit
- 14.8
- upper Limit
- 17.3
- value
- 15.9
- group Id
- OG002
- lower Limit
- 12.4
- upper Limit
- 15.5
- value
- 14.3
- group Id
- OG003
- lower Limit
- 12.4
- upper Limit
- 30.0
- value
- 18.8
- group Id
- OG004
- lower Limit
- 12.9
- upper Limit
- 37.7
- value
- 25.5
- group Id
- OG005
- lower Limit
- 9.13
- upper Limit
- 18.8
- value
- 13.7
- group Id
- OG006
- lower Limit
- 10.9
- upper Limit
- 30.9
- value
- 20.9
- group Id
- OG007
- lower Limit
- 11.2
- upper Limit
- 22.8
- value
- 16.1
- 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
- 7
- units
- Participants
- title
- AMG 224 Conjugated Antibody after Cycle 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 23.2
- value
- 16.5
- group Id
- OG001
- lower Limit
- 13.5
- upper Limit
- 18.2
- value
- 15.8
- group Id
- OG002
- lower Limit
- 15.2
- upper Limit
- 19.8
- value
- 17.8
- group Id
- OG003
- lower Limit
- 14.8
- upper Limit
- 38.0
- value
- 23.9
- group Id
- OG004
- lower Limit
- 25.7
- upper Limit
- 72.8
- value
- 40.5
- group Id
- OG005
- lower Limit
- 15.2
- upper Limit
- 18.3
- value
- 16.8
- group Id
- OG006
- lower Limit
- 15.5
- upper Limit
- 40.7
- value
- 24.6
- group Id
- OG007
- lower Limit
- 12.9
- upper Limit
- 34.6
- value
- 26.2
- 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
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- Total Anti-BCMA Antibody after Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.07
- upper Limit
- 20.5
- value
- 13.4
- group Id
- OG001
- lower Limit
- 12.9
- upper Limit
- 14.3
- value
- 13.4
- group Id
- OG002
- lower Limit
- 8.92
- upper Limit
- 12.6
- value
- 11.4
- group Id
- OG003
- lower Limit
- 9.10
- upper Limit
- 25.8
- value
- 15.8
- group Id
- OG004
- lower Limit
- 9.94
- upper Limit
- 32.6
- value
- 22.1
- group Id
- OG005
- lower Limit
- 9.29
- upper Limit
- 16.2
- value
- 11.4
- group Id
- OG006
- lower Limit
- 10.1
- upper Limit
- 34.6
- value
- 22.4
- group Id
- OG007
- lower Limit
- 11.6
- upper Limit
- 24.8
- value
- 18.6
- 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
- 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
- OG002
- lower Limit
- 20400000
- upper Limit
- 21300000
- value
- 20800000
- group Id
- OG003
- lower Limit
- 6310000
- upper Limit
- 131000000
- value
- 53300000
- group Id
- OG004
- lower Limit
- 2190000
- upper Limit
- 24300000
- value
- 9310000
- group Id
- OG005
- lower Limit
- 3180000
- upper Limit
- 5790000
- value
- 4360000
- group Id
- OG006
- lower Limit
- 3740000
- upper Limit
- 9350000
- value
- 6100000
- group Id
- OG007
- lower Limit
- 2160000
- upper Limit
- 10600000
- value
- 5620000
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- 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
- title
- DM1 after Cycle 1
- categories
- measurements
- group Id
- OG001
- lower Limit
- 18700000
- upper Limit
- 18700000
- value
- 18700000
- group Id
- OG002
- lower Limit
- 13500000
- upper Limit
- 173000000
- value
- 69800000
- group Id
- OG003
- lower Limit
- 5860000
- upper Limit
- 21700000
- value
- 11300000
- group Id
- OG004
- lower Limit
- 2850000
- upper Limit
- 7270000
- value
- 5060000
- group Id
- OG005
- lower Limit
- 2470000
- upper Limit
- 3930000
- value
- 2990000
- group Id
- OG006
- lower Limit
- 3660000
- upper Limit
- 8290000
- value
- 5970000
- group Id
- OG007
- lower Limit
- 2080000
- upper Limit
- 4960000
- value
- 3480000
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- 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
- 7
- 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
- CL of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was determined.
- 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
- Clearance (CL) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
- type
- SECONDARY
- unit Of Measure
- mL/hr
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Preserved source evidence · Not medical advice