TriangleNCT03275285 · OUTCOME
Time to Progression (TTP): 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
TTP was defined as time in months from randomization to the date of first documentation of PD (as determined by the IRC). If progression was not observed before the analysis cut-off date or the date of initiation of further anti-myeloma treatment, TTP was censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. As per IMWG criteria, PD was defined for participants with inc of \>= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute inc must be \>= 0.5 g/dL), serum M-protein inc \>=1 g/dL if the lowest M component was \>=5 g/dL; urine M-component (the absolute inc must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of a previous lesion \>1 centimeter in 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: 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 | 16.986 | NA | Upper limit of the confidence interval could not be reached due to less number of participants with the progression event. |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | NA | Not reported | NA | NA | Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants with the progression event. |
Source statistical analyses
- ci Lower Limit
- 0.324
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.757
- 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 Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Stratified Hazard Ratio
- param Value
- 0.495
Complete source fields
- analyses
- ci Lower Limit
- 0.324
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.757
- 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 Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Stratified Hazard Ratio
- param Value
- 0.495
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval could not be reached due to less number of participants with the progression event.
- group Id
- OG000
- lower Limit
- 16.986
- upper Limit
- NA
- value
- 20.27
- comment
- Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants with the progression event.
- 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
- TTP was defined as time in months from randomization to the date of first documentation of PD (as determined by the IRC). If progression was not observed before the analysis cut-off date or the date of initiation of further anti-myeloma treatment, TTP was censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. As per IMWG criteria, PD was defined for participants with inc of \>= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute inc must be \>= 0.5 g/dL), serum M-protein inc \>=1 g/dL if the lowest M component was \>=5 g/dL; urine M-component (the absolute inc must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of a previous lesion \>1 centimeter in 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 ITT population. 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
- Time to Progression (TTP): Primary Analysis
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice