TriangleNCT04798586 · OUTCOME
Time to Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment)
What was measured
TTR was defined for participants with confirmed objective response (sCR,CR,VGPR and PR) as the time from first date of study intervention to the date of first documentation of objective response. sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine,disappearance of soft tissue plasmacytoma, \<5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum and urine M-protein level \<100mg/24h.PR:\>=50% reduction in serum M-protein and reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h.If serum and urine M-protein unmeasurable,VGPR \& PR: \>=90%,\>=50% decrease in difference respectively between involved and uninvolved sFLC levels,if present at baseline,\>=90%, \>=50% reduction in soft tissue plasmacytomas' size.
Analysis population: SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Groups in this outcome
Elranatamab
Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
| Group | Source count |
|---|---|
| Elranatamab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elranatamab | 1.396 | Not reported | 1.18 | 1.61 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.18
- upper Limit
- 1.61
- value
- 1.396
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- TTR was defined for participants with confirmed objective response (sCR,CR,VGPR and PR) as the time from first date of study intervention to the date of first documentation of objective response. sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine,disappearance of soft tissue plasmacytoma, \<5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum and urine M-protein level \<100mg/24h.PR:\>=50% reduction in serum M-protein and reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h.If serum and urine M-protein unmeasurable,VGPR \& PR: \>=90%,\>=50% decrease in difference respectively between involved and uninvolved sFLC levels,if present at baseline,\>=90%, \>=50% reduction in soft tissue plasmacytomas' size.
- dispersion Type
- Full Range
- groups
- description
- Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
- id
- OG000
- title
- Elranatamab
- param Type
- MEDIAN
- population Description
- SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment)
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice