TriangleNCT04798586 · OUTCOME
Objective Response Rate (ORR): Percentage of Participants With Objective Response
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 date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment)
What was measured
ORR:% of participants with best overall response; confirmed stringent complete response(sCR),CR, very good partial response(VGPR) or PR per International Myeloma Working Group criteria.sCR: CR\& normal serum free light chain(sFLC)ratio \&absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum \&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 \& 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. If serum \& urine M-protein unmeasurable,VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& 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.
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 | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elranatamab | 50.0 | Not reported | 6.8 | 93.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.8
- upper Limit
- 93.2
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- units
- Participants
- description
- ORR:% of participants with best overall response; confirmed stringent complete response(sCR),CR, very good partial response(VGPR) or PR per International Myeloma Working Group criteria.sCR: CR\& normal serum free light chain(sFLC)ratio \&absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum \&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 \& 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. If serum \& urine M-protein unmeasurable,VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline,\>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- SAS included all enrolled participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment)
- title
- Objective Response Rate (ORR): Percentage of Participants With Objective Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice