TriangleNCT01881789 · 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 24 cycles then every 8 weeks until end of treatment; median duration of treatment at the analysis cutoff date of 18 July 2016 was 29.1, 12.4, 11.3, 66.6, 7.8 and 46.4 weeks in each 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 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 SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM).
Analysis population: All participants who received at least 1 dose of any study treatment
Groups in this outcome
Oprozomib 150 mg 5/14 + Lenalidomide + 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 180 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 210 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
Oprozomib 210 mg 2/7 + Lenalidomide + 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 240 mg 2/7 + Lenalidomide + 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 210 mg 2/7 + Cyclophosphamide + 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 oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first. After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.
| Group | Source count |
|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 7 |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 57.1 | Not reported | 18.4 | 90.1 | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 50.0 | Not reported | 1.3 | 98.7 | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG001
- lower Limit
- 18.4
- upper Limit
- 90.1
- value
- 57.1
- group Id
- OG002
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG003
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG004
- lower Limit
- 1.3
- upper Limit
- 98.7
- value
- 50.0
- group Id
- OG005
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- 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 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 SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. sCR: As for CR, and absence of clonal plasma cells in bone marrow (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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG000
- title
- Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 180 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG001
- title
- Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 210 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
- id
- OG002
- title
- Oprozomib 210 mg 5/14 + Lenalidomide + 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG003
- title
- Oprozomib 210 mg 2/7 + Lenalidomide + 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 lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG004
- title
- Oprozomib 240 mg 2/7 + Lenalidomide + 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 oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first. After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG005
- title
- Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of any study treatment
- reporting Status
- POSTED
- time Frame
- Disease response was assessed every 4 weeks for 24 cycles then every 8 weeks until end of treatment; median duration of treatment at the analysis cutoff date of 18 July 2016 was 29.1, 12.4, 11.3, 66.6, 7.8 and 46.4 weeks in each 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