TriangleNCT05565391 · OUTCOME
Objective Response Rate (ORR)-Unweighted Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)
What was measured
ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was PR or better (at least VGPR+PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.
Analysis population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included.
Groups in this outcome
Study C1071003 Cohort A
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
COTA Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
| Group | Source count |
|---|---|
| Study C1071003 Cohort A | 123 |
| COTA Cohort | 233 |
| Flatiron Health Cohort | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Study C1071003 Cohort A | 61.0 | Not reported | 51.8 | 69.6 | Not reported |
| COTA Cohort | 31.3 | Not reported | 25.4 | 37.7 | Not reported |
| Flatiron Health Cohort | 30.3 | Not reported | 23.1 | 38.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.47
- estimate Comment
- Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Risk Ratio (RR)
- param Value
- 1.95
- statistical Method
- Log-binomial regression model
- ci Lower Limit
- 1.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.67
- estimate Comment
- Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Risk Ratio (RR)
- param Value
- 2.01
- statistical Method
- Log-binomial regression model
Complete source fields
- analyses
- ci Lower Limit
- 1.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.47
- estimate Comment
- Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Risk Ratio (RR)
- param Value
- 1.95
- statistical Method
- Log-binomial regression model
- ci Lower Limit
- 1.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.67
- estimate Comment
- Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- <.0001
- param Type
- Risk Ratio (RR)
- param Value
- 2.01
- statistical Method
- Log-binomial regression model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.8
- upper Limit
- 69.6
- value
- 61.0
- group Id
- OG001
- lower Limit
- 25.4
- upper Limit
- 37.7
- value
- 31.3
- group Id
- OG002
- lower Limit
- 23.1
- upper Limit
- 38.2
- value
- 30.3
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 233
- group Id
- OG002
- value
- 152
- units
- Participants
- description
- ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was PR or better (at least VGPR+PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
- id
- OG000
- title
- Study C1071003 Cohort A
- description
- Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
- id
- OG001
- title
- COTA Cohort
- description
- Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
- id
- OG002
- title
- Flatiron Health Cohort
- param Type
- NUMBER
- population Description
- Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included.
- reporting Status
- POSTED
- time Frame
- From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)
- title
- Objective Response Rate (ORR)-Unweighted Analysis
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice