TriangleNCT01999335 · OUTCOME
Clinical Benefit Rate (CBR)
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
Clinical benefit rate is defined as the percentage of participants with a best overall response of minimal response (MR) per modified European Group for Blood and Marrow Transplantation criteria, or PR, VGPR, CR, or sCR as determined by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). MR: * ≥ 25% but \< 49% reduction in serum M-protein and a 50 - 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg per 24 hours * If the serum and urine M-protein were not measurable, a decrease of 25 - 49% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. * For patients with nonsecretory myeloma only, 25 - 49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed * 25 - 49% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination)
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
- Clinical benefit rate is defined as the percentage of participants with a best overall response of minimal response (MR) per modified European Group for Blood and Marrow Transplantation criteria, or PR, VGPR, CR, or sCR as determined by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). MR: * ≥ 25% but \< 49% reduction in serum M-protein and a 50 - 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg per 24 hours * If the serum and urine M-protein were not measurable, a decrease of 25 - 49% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. * For patients with nonsecretory myeloma only, 25 - 49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed * 25 - 49% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination)
- 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
- Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice