TriangleNCT05932290 · OUTCOME
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW 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
- C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
What was measured
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.
Analysis population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. IPTW analysis: eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "N" are different from participant and baseline section. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.
Groups in this outcome
C1071003 Cohort A
Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.
RWD: Flatiron Health
Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database were included. This arm served as external control arm.
| Group | Source count |
|---|---|
| C1071003 Cohort A | 113 |
| RWD: Flatiron Health | 150 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| C1071003 Cohort A | NA | Not reported | NA | NA | Median and 95% CI was not estimated because of insufficient number of participants with the event. |
| RWD: Flatiron Health | 2.79 | Not reported | 1.87 | 5.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI was not estimated because of insufficient number of participants with the event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 1.87
- upper Limit
- 5.59
- value
- 2.79
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 150
- units
- Participants
- description
- PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.
- id
- OG000
- title
- C1071003 Cohort A
- description
- Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database were included. This arm served as external control arm.
- id
- OG001
- title
- RWD: Flatiron Health
- param Type
- MEDIAN
- population Description
- Eligible participants whose data was retrieved and was used in this retrospective cohort study. IPTW analysis: eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "N" are different from participant and baseline section. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.
- reporting Status
- POSTED
- time Frame
- C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
- title
- PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice