TriangleNCT03582033 · OUTCOME
ORR as Per the IMWG Uniform Response Criteria: Part B
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 34 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 or \>= 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 B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, 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 B: SEA-BCMA 1600mg | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: SEA-BCMA 1600mg | 20 | Not reported | 5.7 | 43.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- 43.7
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 20
- 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 or \>= 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 as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, 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 B: SEA-BCMA 1600mg
- 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 34 months)
- title
- ORR as Per the IMWG Uniform Response Criteria: Part B
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice