TriangleNCT02579863 · OUTCOME
Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
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
- Up to approximately 30 months
What was measured
ORR was based on participants who achieved at least a partial response (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+partial response \[PR\]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. The data cutoff date was July 9, 2018.
Analysis population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab + Lenalidomide + Dexamethasone
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Lenolidomide + Dexamethasone
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
| Group | Source count |
|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 156 |
| Lenolidomide + Dexamethasone | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 74.4 | Not reported | 66.8 | 81.0 | Not reported |
| Lenolidomide + Dexamethasone | 68.8 | Not reported | 60.9 | 76.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.
- p Value
- 0.13102
- param Type
- Difference in % vs SOC
- param Value
- 5.8
- statistical Comment
- H0: difference in % =0 versus H1: difference in % \> 0.
- statistical Method
- One-sided p-value for testing
Complete source fields
- analyses
- ci Lower Limit
- -4.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.
- p Value
- 0.13102
- param Type
- Difference in % vs SOC
- param Value
- 5.8
- statistical Comment
- H0: difference in % =0 versus H1: difference in % \> 0.
- statistical Method
- One-sided p-value for testing
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.8
- upper Limit
- 81.0
- value
- 74.4
- group Id
- OG001
- lower Limit
- 60.9
- upper Limit
- 76.0
- value
- 68.8
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- ORR was based on participants who achieved at least a partial response (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+partial response \[PR\]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. The data cutoff date was July 9, 2018.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG000
- title
- Pembrolizumab + Lenalidomide + Dexamethasone
- description
- Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG001
- title
- Lenolidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 30 months
- title
- Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice