TriangleNCT02939183 · OUTCOME
Best Overall Response (BOR) According to Revised 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 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
What was measured
BOR was the best response per IMWG-URC from best to worst: stringent complete response (sCR; complete response \[CR\], normal serum free light chain ratio, no clonal cells in bone marrow \[BM\]), CR (negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM), very good partial response (VGPR; serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein \[urine M-protein level \< 100 mg/24-h\]), partial response (PR; ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or \< 200 mg/24-h), minimal 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 CR, VGPR, PR or progressive disease \[PD\]), and 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: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
Groups in this outcome
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 3 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 6 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 7 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 8 |
Reported measurements
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
Unconfirmed response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
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- OG000
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- VGPR
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- 1
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- 1
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- group Id
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- 3
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 0
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- 0
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- value
- 2
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- 1
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- 0
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- 0
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- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 0
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- 4
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- OG002
- value
- 0
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- value
- 1
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- OG004
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- 0
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- OG007
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- 0
- title
- SD
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- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
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- 0
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- OG002
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- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
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- OG005
- value
- 0
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- 0
- group Id
- OG007
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- 0
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
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- 1
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- OG002
- value
- 0
- group Id
- OG003
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- 1
- group Id
- OG004
- value
- 1
- group Id
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- value
- 2
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- 0
- group Id
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- 1
- title
- Unconfirmed response
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
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- value
- 3
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- OG004
- value
- 7
- group Id
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- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 8
- units
- Participants
- description
- BOR was the best response per IMWG-URC from best to worst: stringent complete response (sCR; complete response \[CR\], normal serum free light chain ratio, no clonal cells in bone marrow \[BM\]), CR (negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM), very good partial response (VGPR; serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein \[urine M-protein level \< 100 mg/24-h\]), partial response (PR; ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or \< 200 mg/24-h), minimal 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 CR, VGPR, PR or progressive disease \[PD\]), and 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
- In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG000
- title
- Oprozomib IR 150 mg/Day + Dexamethsone
- description
- In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG001
- title
- Oprozomib GR 150 mg/Day + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG002
- title
- Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG003
- title
- Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG004
- title
- Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG005
- title
- Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG006
- title
- Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG007
- title
- Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
- title
- Best Overall Response (BOR) According to Revised 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