TriangleNCT03215030 · OUTCOME
Part 3: Objective Response Rate (ORR) by Investigator Assessment
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
- Up to 20.5 months in Part 3
What was measured
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. Percentages were rounded off to the nearest decimal.
Analysis population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
Groups in this outcome
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 71 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 75 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 32.4 | Not reported | 21.76 | 44.55 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 41.3 | Not reported | 30.08 | 53.30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.76
- upper Limit
- 44.55
- value
- 32.4
- group Id
- OG001
- lower Limit
- 30.08
- upper Limit
- 53.30
- value
- 41.3
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. Percentages were rounded off to the nearest decimal.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG000
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG001
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- NUMBER
- population Description
- The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
- reporting Status
- POSTED
- time Frame
- Up to 20.5 months in Part 3
- title
- Part 3: Objective Response Rate (ORR) by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice