TriangleNCT03275285 · OUTCOME
Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
What was measured
Time (in months) from randomization to date of 1st PD documentation/death date, whichever is 1st. If PD \& death not observed before cut-off date/date of further anti-myeloma treatment initiation, PFS censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever was 1st. Progression/deaths occurring \>8 weeks after last disease assessment censored at earliest date of last disease assessment without evidence of progression before initiation of new anti-myeloma treatment \& cut-off date. PD (IMWG criteria): meeting any 1: Inc \>=25% in Serum M-component from nadir; serum M component inc \>=1 g/dL in 2 consecutive assessment, if starting M component \>=5 g/dL; and/or inc \>=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion \>1 cm short axis.
Analysis population: Analysis was performed on the ITT. Analysis was performed by Kaplan-Meier method.
Groups in this outcome
Carfilzomib + Dexamethasone (Kd)
Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
Isatuximab + Carfilzomib + Dexamethasone (IKd)
Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
| Group | Source count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) | 123 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 20.27 | Not reported | 15.770 | NA | Upper limit of the confidence interval could not be reached due to less number of participants with the events. |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | NA | Not reported | NA | NA | Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had PFS events. |
Source statistical analyses
- ci Lower Limit
- 0.317
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.2
- ci Upper Limit
- 0.948
- estimate Comment
- Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.
- group Description
- Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0016
- p Value Comment
- One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.548
- statistical Comment
- Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.
- statistical Method
- Stratified Log-Rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.317
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.2
- ci Upper Limit
- 0.948
- estimate Comment
- Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.
- group Description
- Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0016
- p Value Comment
- One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.548
- statistical Comment
- Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.
- statistical Method
- Stratified Log-Rank test
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval could not be reached due to less number of participants with the events.
- group Id
- OG000
- lower Limit
- 15.770
- upper Limit
- NA
- value
- 20.27
- comment
- Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had PFS events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- Time (in months) from randomization to date of 1st PD documentation/death date, whichever is 1st. If PD \& death not observed before cut-off date/date of further anti-myeloma treatment initiation, PFS censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever was 1st. Progression/deaths occurring \>8 weeks after last disease assessment censored at earliest date of last disease assessment without evidence of progression before initiation of new anti-myeloma treatment \& cut-off date. PD (IMWG criteria): meeting any 1: Inc \>=25% in Serum M-component from nadir; serum M component inc \>=1 g/dL in 2 consecutive assessment, if starting M component \>=5 g/dL; and/or inc \>=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion \>1 cm short axis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
- id
- OG000
- title
- Carfilzomib + Dexamethasone (Kd)
- description
- Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
- id
- OG001
- title
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- param Type
- MEDIAN
- population Description
- Analysis was performed on the ITT. Analysis was performed by Kaplan-Meier method.
- reporting Status
- POSTED
- time Frame
- From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
- title
- Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice