TriangleNCT02561962 · OUTCOME
Best Overall Response (BOR) According to International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
What was measured
BOR was the best observed post baseline disease response per IMWG-URC: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Minor Response (MR): 25-49% reduction of serum M-protein and 50-89% in 24-h urinary M-protein, exceeding 200 mg/24-h. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or Progressive Disease (PD). PD: ≥ 25% increase in serum or urine M-component, development of new or increased size of existing bone lesions or soft tissue plasmacytomas, hypercalcemia attributed to the plasma cell proliferative disorder.
Analysis population: Safety analysis set included all participants who received at least 1 dose of AMG 224.
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 Dose H + Prior CD38 Targeting Antibody Treatment
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion 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 | 6 |
| Dose Exploration: AMG 224 Dose F | 6 |
| Dose Exploration: AMG 224 Dose G | 5 |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 9 |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 2 |
Reported measurements
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
Unevaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- sCR
- categories
- measurements
- 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
- 1
- group Id
- OG008
- value
- 0
- title
- CR
- categories
- measurements
- 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
- group Id
- OG008
- value
- 1
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- PR
- categories
- measurements
- 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
- 1
- group Id
- OG008
- value
- 0
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- title
- Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- title
- Unevaluable
- 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
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- BOR was the best observed post baseline disease response per IMWG-URC: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Minor Response (MR): 25-49% reduction of serum M-protein and 50-89% in 24-h urinary M-protein, exceeding 200 mg/24-h. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or Progressive Disease (PD). PD: ≥ 25% increase in serum or urine M-component, development of new or increased size of existing bone lesions or soft tissue plasmacytomas, hypercalcemia attributed to the plasma cell proliferative disorder.
- 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
- Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG007
- title
- Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
- description
- Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG008
- title
- Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 dose of AMG 224.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
- title
- Best Overall Response (BOR) According to International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice