TriangleNCT04776018 · OUTCOME
Phase 2: DOR Based on IMWG Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 24 months
What was measured
DOR was defined as a time from date of first documentation of a PR or better to the date of first documentation of PD based on IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM. PR: \>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \<200 mg/24 h; If the serum and urine M-protein were unmeasurable, a \>50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was \>30%. In addition to the above listed criteria, if present at baseline, a \>50% reduction in the size of soft tissue plasmacytomas is also required.
Analysis population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.
Groups in this outcome
Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
| Group | Source count |
|---|---|
| Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- DOR was defined as a time from date of first documentation of a PR or better to the date of first documentation of PD based on IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM. PR: \>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \<200 mg/24 h; If the serum and urine M-protein were unmeasurable, a \>50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was \>30%. In addition to the above listed criteria, if present at baseline, a \>50% reduction in the size of soft tissue plasmacytomas is also required.
- groups
- description
- Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
- id
- OG000
- title
- Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
- population Description
- The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Phase 2: DOR Based on IMWG Criteria
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice