TriangleNCT01999335 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Disease response was assessed every 4 weeks for the first 18 months and then every 8 weeks for the remainder of study treatment; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
What was measured
ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria. PR: ≥ 50% reduction of serum M-protein and ≥90% reduction in urine M-protein or to \< 200 mg/24 hrs, or a ≥50% decrease in the difference between involved and uninvolved free light chain levels (dFLC). A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein \<100 mg/24 hrs. If disease measurable only by serum FLC (SFLC), ≥ 90% decrease in dFLC. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow (BM). Normal SFLC ratio if disease measurable only by SFLC. sCR: As for CR, and absence of clonal plasma cells in BM.
Analysis population: Participants who received at least 1 dose of any study drug
Groups in this outcome
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone | 3 |
| Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone | 1 |
| Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone | 7 |
| Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone | 10 |
| Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone | 100.0 | Not reported | 2.5 | 100.0 | Not reported |
| Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone | 85.7 | Not reported | 42.1 | 99.6 | Not reported |
| Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone | 60.0 | Not reported | 26.2 | 87.8 | Not reported |
| Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase | 60.0 | Not reported | 26.2 | 87.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG001
- lower Limit
- 2.5
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG002
- lower Limit
- 42.1
- upper Limit
- 99.6
- value
- 85.7
- group Id
- OG003
- lower Limit
- 26.2
- upper Limit
- 87.8
- value
- 60.0
- group Id
- OG004
- lower Limit
- 26.2
- upper Limit
- 87.8
- value
- 60.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 10
- units
- Participants
- description
- ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria. PR: ≥ 50% reduction of serum M-protein and ≥90% reduction in urine M-protein or to \< 200 mg/24 hrs, or a ≥50% decrease in the difference between involved and uninvolved free light chain levels (dFLC). A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein \<100 mg/24 hrs. If disease measurable only by serum FLC (SFLC), ≥ 90% decrease in dFLC. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow (BM). Normal SFLC ratio if disease measurable only by SFLC. sCR: As for CR, and absence of clonal plasma cells in BM.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
- description
- Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
- description
- Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG003
- title
- Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG004
- title
- Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
- param Type
- NUMBER
- population Description
- Participants who received at least 1 dose of any study drug
- reporting Status
- POSTED
- time Frame
- Disease response was assessed every 4 weeks for the first 18 months and then every 8 weeks for the remainder of study treatment; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice