TriangleNCT03275285 · OUTCOME
Time to Best Response: 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 to best response was defined as time (in months) from randomization to the date of first occurrence of IRC determined as best overall response (PR or better) that is subsequently confirmed. In absence of response, participants were censored at earliest date of last valid disease assessment before disease progression/death, date of last valid disease assessment before initiation of further anti-myeloma treatment (if any)/ analysis cut-off date, whichever was 1st. PR (IMWG criteria) was defined as \>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>=90% or to \<200 mg/24 h. In addition to above listed criteria, if present at baseline, a \>=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. Best Overall Response was defined as the best response, using the IRC's assessment of response, from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date, whichever occurs 1st.
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) | 3.78 | Not reported | 2.858 | 4.172 | Not reported |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 4.60 | Not reported | 3.811 | 5.257 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.740
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.233
- 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
- 0.955
Complete source fields
- analyses
- ci Lower Limit
- 0.740
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.233
- 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
- 0.955
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.858
- upper Limit
- 4.172
- value
- 3.78
- group Id
- OG001
- lower Limit
- 3.811
- upper Limit
- 5.257
- value
- 4.60
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- Time to best response was defined as time (in months) from randomization to the date of first occurrence of IRC determined as best overall response (PR or better) that is subsequently confirmed. In absence of response, participants were censored at earliest date of last valid disease assessment before disease progression/death, date of last valid disease assessment before initiation of further anti-myeloma treatment (if any)/ analysis cut-off date, whichever was 1st. PR (IMWG criteria) was defined as \>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>=90% or to \<200 mg/24 h. In addition to above listed criteria, if present at baseline, a \>=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. Best Overall Response was defined as the best response, using the IRC's assessment of response, from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date, whichever occurs 1st.
- 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 Best Response: Primary Analysis
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice