TriangleNCT03275285 · OUTCOME
Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
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 final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
What was measured
PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of \>= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>= 0.5 g/dL), serum M-protein increase \>=1 g/dL if lowest M component was \>=5 g/dL; urine M-component (absolute increase must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter short axis.
Analysis population: Analysis was performed on ITT population. 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: 208 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: 215 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) | 35.58 | Not reported | 24.049 | 40.509 | Not reported |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 47.18 | Not reported | 38.111 | NA | Upper limit of confidence interval could not be calculated because not enough participants with PFS2 events. |
Source statistical analyses
- ci Lower Limit
- 0.496
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.941
- estimate Comment
- Stratification was done on the 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
- \[Not specified\]
- group Ids
- OG000
- OG001
- non Inferiority Comment
- \[Not specified\]
- non Inferiority Type
- SUPERIORITY
- param Type
- [Stratified Hazard Ratio]
- param Value
- 0.683
Complete source fields
- analyses
- ci Lower Limit
- 0.496
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.941
- estimate Comment
- Stratification was done on the 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
- \[Not specified\]
- group Ids
- OG000
- OG001
- non Inferiority Comment
- \[Not specified\]
- non Inferiority Type
- SUPERIORITY
- param Type
- [Stratified Hazard Ratio]
- param Value
- 0.683
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.049
- upper Limit
- 40.509
- value
- 35.58
- comment
- Upper limit of confidence interval could not be calculated because not enough participants with PFS2 events.
- group Id
- OG001
- lower Limit
- 38.111
- upper Limit
- NA
- value
- 47.18
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of \>= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>= 0.5 g/dL), serum M-protein increase \>=1 g/dL if lowest M component was \>=5 g/dL; urine M-component (absolute increase must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter 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: 208 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: 215 weeks).
- id
- OG001
- title
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
- reporting Status
- POSTED
- time Frame
- From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
- title
- Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice