TriangleNCT02561962 · OUTCOME
Terminal Half-life (t1/2,z) 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
- MEDIAN
- Unit
- hours
- 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
The t1/2,z 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. 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 | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 3 |
| Dose Exploration: AMG 224 Dose B | 3 |
| Dose Exploration: AMG 224 Dose C | 1 |
| Dose Exploration: AMG 224 Dose D | 2 |
| Dose Exploration: AMG 224 Dose E | 5 |
| Dose Exploration: AMG 224 Dose F | 1 |
| Dose Exploration: AMG 224 Dose G | 2 |
| Dose Expansion: AMG 224 3 mg/kg | 6 |
Reported measurements
AMG 224 Conjugated Antibody after Cycle 1
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 2 |
| Dose Exploration: AMG 224 Dose B | 3 |
| Dose Exploration: AMG 224 Dose C | 1 |
| Dose Exploration: AMG 224 Dose D | 2 |
| Dose Exploration: AMG 224 Dose E | 3 |
| Dose Exploration: AMG 224 Dose F | 1 |
| Dose Exploration: AMG 224 Dose G | 2 |
| Dose Expansion: AMG 224 3 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 217 | Not reported | 217 | 218 | Not reported |
| Dose Exploration: AMG 224 Dose B | 218 | Not reported | 191 | 284 | Not reported |
| Dose Exploration: AMG 224 Dose C | 278 | Not reported | 278 | 278 | Not reported |
| Dose Exploration: AMG 224 Dose D | 196 | Not reported | 174 | 219 | Not reported |
| Dose Exploration: AMG 224 Dose E | 139 | Not reported | 135 | 160 | Not reported |
| Dose Exploration: AMG 224 Dose F | 189 | Not reported | 189 | 189 | Not reported |
| Dose Exploration: AMG 224 Dose G | 195 | Not reported | 192 | 198 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 199 | Not reported | 158 | 217 | 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 | 2 |
| Dose Exploration: AMG 224 Dose C | 0 |
| Dose Exploration: AMG 224 Dose D | 2 |
| Dose Exploration: AMG 224 Dose E | 3 |
| Dose Exploration: AMG 224 Dose F | 1 |
| Dose Exploration: AMG 224 Dose G | 1 |
| Dose Expansion: AMG 224 3 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 201 | Not reported | 194 | 215 | Not reported |
| Dose Exploration: AMG 224 Dose B | 221 | Not reported | 193 | 249 | Not reported |
| Dose Exploration: AMG 224 Dose D | 189 | Not reported | 159 | 220 | Not reported |
| Dose Exploration: AMG 224 Dose E | 243 | Not reported | 155 | 300 | Not reported |
| Dose Exploration: AMG 224 Dose F | 164 | Not reported | 164 | 164 | Not reported |
| Dose Exploration: AMG 224 Dose G | 179 | Not reported | 179 | 179 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 241 | Not reported | 174 | 280 | Not reported |
Total Anti-BCMA Antibody after Cycle 1
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 2 |
| Dose Exploration: AMG 224 Dose B | 1 |
| Dose Exploration: AMG 224 Dose C | 0 |
| Dose Exploration: AMG 224 Dose D | 2 |
| Dose Exploration: AMG 224 Dose E | 4 |
| Dose Exploration: AMG 224 Dose F | 1 |
| Dose Exploration: AMG 224 Dose G | 1 |
| Dose Expansion: AMG 224 3 mg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 234 | Not reported | 231 | 238 | Not reported |
| Dose Exploration: AMG 224 Dose B | 198 | Not reported | 198 | 198 | Not reported |
| Dose Exploration: AMG 224 Dose D | 242 | Not reported | 197 | 287 | Not reported |
| Dose Exploration: AMG 224 Dose E | 155 | Not reported | 51.0 | 189 | Not reported |
| Dose Exploration: AMG 224 Dose F | 238 | Not reported | 238 | 238 | Not reported |
| Dose Exploration: AMG 224 Dose G | 170 | Not reported | 170 | 170 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 194 | Not reported | 172 | 216 | 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 | 1 |
| Dose Exploration: AMG 224 Dose C | 0 |
| Dose Exploration: AMG 224 Dose D | 2 |
| Dose Exploration: AMG 224 Dose E | 1 |
| Dose Exploration: AMG 224 Dose F | 0 |
| Dose Exploration: AMG 224 Dose G | 1 |
| Dose Expansion: AMG 224 3 mg/kg | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 269 | Not reported | 250 | 277 | Not reported |
| Dose Exploration: AMG 224 Dose B | 255 | Not reported | 255 | 255 | Not reported |
| Dose Exploration: AMG 224 Dose D | 230 | Not reported | 211 | 249 | Not reported |
| Dose Exploration: AMG 224 Dose E | 351 | Not reported | 351 | 351 | Not reported |
| Dose Exploration: AMG 224 Dose G | 147 | Not reported | 147 | 147 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 199 | Not reported | 157 | 290 | 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 | 0 |
| Dose Exploration: AMG 224 Dose D | 0 |
| Dose Exploration: AMG 224 Dose E | 1 |
| Dose Exploration: AMG 224 Dose F | 1 |
| Dose Exploration: AMG 224 Dose G | 0 |
| Dose Expansion: AMG 224 3 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose E | 50.2 | Not reported | 50.2 | 50.2 | Not reported |
| Dose Exploration: AMG 224 Dose F | 52.1 | Not reported | 52.1 | 52.1 | Not reported |
| Dose Expansion: AMG 224 3 mg/kg | 48.8 | Not reported | 48.8 | 48.8 | Not reported |
DM1 after Cycle 2
| 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 | 0 |
| Dose Exploration: AMG 224 Dose F | 0 |
| Dose Exploration: AMG 224 Dose G | 0 |
| Dose Expansion: AMG 224 3 mg/kg | 0 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 217
- upper Limit
- 218
- value
- 217
- group Id
- OG001
- lower Limit
- 191
- upper Limit
- 284
- value
- 218
- group Id
- OG002
- lower Limit
- 278
- upper Limit
- 278
- value
- 278
- group Id
- OG003
- lower Limit
- 174
- upper Limit
- 219
- value
- 196
- group Id
- OG004
- lower Limit
- 135
- upper Limit
- 160
- value
- 139
- group Id
- OG005
- lower Limit
- 189
- upper Limit
- 189
- value
- 189
- group Id
- OG006
- lower Limit
- 192
- upper Limit
- 198
- value
- 195
- group Id
- OG007
- lower Limit
- 158
- upper Limit
- 217
- value
- 199
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- AMG 224 Conjugated Antibody after Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 194
- upper Limit
- 215
- value
- 201
- group Id
- OG001
- lower Limit
- 193
- upper Limit
- 249
- value
- 221
- group Id
- OG003
- lower Limit
- 159
- upper Limit
- 220
- value
- 189
- group Id
- OG004
- lower Limit
- 155
- upper Limit
- 300
- value
- 243
- group Id
- OG005
- lower Limit
- 164
- upper Limit
- 164
- value
- 164
- group Id
- OG006
- lower Limit
- 179
- upper Limit
- 179
- value
- 179
- group Id
- OG007
- lower Limit
- 174
- upper Limit
- 280
- value
- 241
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- AMG 224 Conjugated Antibody after Cycle 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 231
- upper Limit
- 238
- value
- 234
- group Id
- OG001
- lower Limit
- 198
- upper Limit
- 198
- value
- 198
- group Id
- OG003
- lower Limit
- 197
- upper Limit
- 287
- value
- 242
- group Id
- OG004
- lower Limit
- 51.0
- upper Limit
- 189
- value
- 155
- group Id
- OG005
- lower Limit
- 238
- upper Limit
- 238
- value
- 238
- group Id
- OG006
- lower Limit
- 170
- upper Limit
- 170
- value
- 170
- group Id
- OG007
- lower Limit
- 172
- upper Limit
- 216
- value
- 194
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- units
- Participants
- title
- Total Anti-BCMA Antibody after Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 250
- upper Limit
- 277
- value
- 269
- group Id
- OG001
- lower Limit
- 255
- upper Limit
- 255
- value
- 255
- group Id
- OG003
- lower Limit
- 211
- upper Limit
- 249
- value
- 230
- group Id
- OG004
- lower Limit
- 351
- upper Limit
- 351
- value
- 351
- group Id
- OG006
- lower Limit
- 147
- upper Limit
- 147
- value
- 147
- group Id
- OG007
- lower Limit
- 157
- upper Limit
- 290
- value
- 199
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 4
- units
- Participants
- title
- Total Anti-BCMA Antibody after Cycle 2
- categories
- measurements
- group Id
- OG004
- lower Limit
- 50.2
- upper Limit
- 50.2
- value
- 50.2
- group Id
- OG005
- lower Limit
- 52.1
- upper Limit
- 52.1
- value
- 52.1
- group Id
- OG007
- lower Limit
- 48.8
- upper Limit
- 48.8
- value
- 48.8
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- DM1 after Cycle 1
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- title
- DM1 after Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- The t1/2,z 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
- MEDIAN
- 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 (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)
- title
- Terminal Half-life (t1/2,z) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice