TriangleNCT03215030 · OUTCOME
Parts 1, 2, and 3: Duration of Response (DOR)
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
- Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
What was measured
DOR was defined as the time from the date of first documentation of response PR or better (sCR + CR + VGPR + PR) to the time of disease progression or death, whichever occurs first. 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.
Analysis population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analyses.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
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 1 (Dose Escalation) Schedule A | 3 |
| Part 1 (Dose Escalation) Schedule B | 0 |
| Part 1 (Dose Escalation) Schedule C | 0 |
| Part 1 (Dose Escalation) Schedule D | 2 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 0 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 0 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 7 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 3 |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 6 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 2.1 | Not reported | 2.0 | 12.0 | Not reported |
| Part 1 (Dose Escalation) Schedule D | 7.4 | Not reported | 2.8 | 24.8 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 24.4 | Not reported | 1.0 | 39.7 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 10.3 | Not reported | 1.0 | 17.6 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | NA | Not reported | 2.07 | 13.57 | Median was not reached. |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 9.2 | Not reported | 0.76 | 16.82 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 12.0
- value
- 2.1
- group Id
- OG003
- lower Limit
- 2.8
- upper Limit
- 24.8
- value
- 7.4
- group Id
- OG006
- lower Limit
- 1.0
- upper Limit
- 39.7
- value
- 24.4
- group Id
- OG007
- lower Limit
- 1.0
- upper Limit
- 17.6
- value
- 10.3
- comment
- Median was not reached.
- group Id
- OG008
- lower Limit
- 2.07
- upper Limit
- 13.57
- value
- NA
- group Id
- OG009
- lower Limit
- 0.76
- upper Limit
- 16.82
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 13
- units
- Participants
- description
- DOR was defined as the time from the date of first documentation of response PR or better (sCR + CR + VGPR + PR) to the time of disease progression or death, whichever occurs first. 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.
- dispersion Type
- Full Range
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule D
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG004
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG005
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG006
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG007
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG008
- 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
- OG009
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- MEDIAN
- population Description
- The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
- title
- Parts 1, 2, and 3: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice