TriangleNCT03582033 · OUTCOME
ORR as Per the IMWG Uniform Response Criteria: Part D
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 the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
What was measured
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Groups in this outcome
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
| Group | Source count |
|---|---|
| Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | 80 | Not reported | 28.4 | 99.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.4
- upper Limit
- 99.5
- value
- 80
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG000
- title
- Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
- param Type
- NUMBER
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
- title
- ORR as Per the IMWG Uniform Response Criteria: Part D
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice