TriangleNCT04649359 · OUTCOME
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
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 (up to approximately 16 months)
What was measured
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. 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 disease measurable 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 M-protein \& 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 were 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: Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention.
Groups in this outcome
Cohort A
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
| Group | Source count |
|---|---|
| Cohort A | 123 |
| Cohort B | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 61.0 | Not reported | 51.8 | 69.6 | Not reported |
| Cohort B | 34.4 | Not reported | 22.9 | 47.3 | Not reported |
Source statistical analyses
- group Description
- Null hypothesis of ORR by BICR for cohort A was 30%.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Exact binominal
- group Description
- Null hypothesis of ORR by BICR for cohort B was 15%.
- group Ids
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Exact binominal
Complete source fields
- analyses
- group Description
- Null hypothesis of ORR by BICR for cohort A was 30%.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Exact binominal
- group Description
- Null hypothesis of ORR by BICR for cohort B was 15%.
- group Ids
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Exact binominal
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.8
- upper Limit
- 69.6
- value
- 61.0
- group Id
- OG001
- lower Limit
- 22.9
- upper Limit
- 47.3
- value
- 34.4
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 64
- units
- Participants
- description
- ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. 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 disease measurable 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 M-protein \& 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 were 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
- BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
- id
- OG000
- title
- Cohort A
- description
- BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
- id
- OG001
- title
- Cohort B
- param Type
- NUMBER
- population Description
- Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one 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 (up to approximately 16 months)
- title
- Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice