TriangleNCT03215030 · OUTCOME
Parts 1 and 2: Time to Response
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
What was measured
Time to response was defined as the time from first dose to the date of first documentation of response (PR or better \[sCR + CR + VGPR + PR\]) 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.
| 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 | 5 |
| 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 | 12 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 1.15 | Not reported | 1.0 | 3.0 | Not reported |
| Part 1 (Dose Escalation) Schedule D | 1.87 | Not reported | 0.9 | 3.7 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 1.07 | Not reported | 0.8 | 5.8 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 1.08 | Not reported | 1.0 | 10.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 3.0
- value
- 1.15
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 3.7
- value
- 1.87
- group Id
- OG006
- lower Limit
- 0.8
- upper Limit
- 5.8
- value
- 1.07
- group Id
- OG007
- lower Limit
- 1.0
- upper Limit
- 10.0
- value
- 1.08
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 8
- units
- Participants
- description
- Time to response was defined as the time from first dose to the date of first documentation of response (PR or better \[sCR + CR + VGPR + PR\]) 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
- 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
- title
- Parts 1 and 2: Time to Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice