TriangleNCT02675452 · OUTCOME
Best Overall Response According to Revised International Working Group Uniform Response Criteria (IMWG-URC) for MM Participants (Parts 1A and 1B)
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 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
What was measured
A response consisted of any of the following, assessed according to the IMWG-URC: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hrs). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hrs urinary M-protein by ≥ 90% or to \< 200 mg/24-hours; MR: 25-49% reduction in serum M-protein and 50-89% reduction in 24-hr urinary M-protein (\>200 mg/24-hrs); SD: not meeting criteria for CR, VGPR, PR, or PD; PD: ≥ 25% increase in serum or urine M-component, BM plasma cell percentages.
Analysis population: The FAS included all participants who received at least 1 dose of AMG 176.
Groups in this outcome
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
| Group | Source count |
|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 3 |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3 |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 4 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 3 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 3 |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 2 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 4 |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 4 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 5 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5 |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 3 |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 3 |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 3 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 3 |
Reported measurements
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 3 | Not reported | Not reported | Not reported | Not reported |
No post-baseline response evaluation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | 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
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- 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
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- 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
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- VGPR
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- 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
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- MR
- 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
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 1
- title
- PD
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- No post-baseline response evaluation
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- A response consisted of any of the following, assessed according to the IMWG-URC: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hrs). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hrs urinary M-protein by ≥ 90% or to \< 200 mg/24-hours; MR: 25-49% reduction in serum M-protein and 50-89% reduction in 24-hr urinary M-protein (\>200 mg/24-hrs); SD: not meeting criteria for CR, VGPR, PR, or PD; PD: ≥ 25% increase in serum or urine M-component, BM plasma cell percentages.
- groups
- description
- Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG000
- title
- Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
- description
- Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG001
- title
- Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
- description
- Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG002
- title
- Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
- description
- Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG003
- title
- Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
- description
- Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG004
- title
- Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
- description
- Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG005
- title
- Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG006
- title
- Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG007
- title
- Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG008
- title
- Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG009
- title
- Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG010
- title
- Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG011
- title
- Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The FAS included all participants who received at least 1 dose of AMG 176.
- reporting Status
- POSTED
- time Frame
- Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
- title
- Best Overall Response According to Revised International Working Group Uniform Response Criteria (IMWG-URC) for MM Participants (Parts 1A and 1B)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice