TriangleNCT03582033 · OUTCOME
DOR as Per the IMWG Uniform Response Criteria: Part C
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 the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
What was measured
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal 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 \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone | 2 |
| Part C: SEA-BCMA 800mg and Dexamethasone | 2 |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: SEA-BCMA 1600mg and Dexamethasone | NA | Not reported | 4.6 | 35.7 | Median could not be calculated due to insufficient number of participants with events. |
| Part C: SEA-BCMA 800mg and Dexamethasone | NA | Not reported | 1.9 | 22.6 | Median could not be calculated due to insufficient number of participants with events. |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 6.5 | Not reported | 6.5 | 6.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median could not be calculated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 35.7
- value
- NA
- comment
- Median could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 22.6
- value
- NA
- group Id
- OG002
- lower Limit
- 6.5
- upper Limit
- 6.5
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal 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 \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
- dispersion Type
- Full Range
- groups
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone
- description
- Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG001
- title
- Part C: SEA-BCMA 800mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG002
- title
- Part C: SEA-BCMA 1600 mg and Dexamethasone
- param Type
- MEDIAN
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
- title
- DOR as Per the IMWG Uniform Response Criteria: Part C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice