TriangleNCT03215030 · OUTCOME
Parts 1, 2, and 3: Progression Free Survival (PFS)
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
PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Analysis population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analysis.
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 | 15 |
| Part 1 (Dose Escalation) Schedule B | 7 |
| Part 1 (Dose Escalation) Schedule C | 6 |
| Part 1 (Dose Escalation) Schedule D | 15 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 7 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 2 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 18 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 13 |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 43 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 2.6 | Not reported | 0.0 | 13.1 | Not reported |
| Part 1 (Dose Escalation) Schedule B | 1.5 | Not reported | 0.2 | 5.4 | Not reported |
| Part 1 (Dose Escalation) Schedule C | 1.4 | Not reported | 0.1 | 6.2 | Not reported |
| Part 1 (Dose Escalation) Schedule D | 3.6 | Not reported | 0.0 | 26.5 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 1.1 | Not reported | 0.5 | 2.3 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 1.4 | Not reported | 0.7 | 1.4 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 8.0 | Not reported | 0.0 | 40.4 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 3.4 | Not reported | 0.0 | 22.7 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 4.1 | Not reported | 0.03 | 15.44 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 5.3 | Not reported | 0.03 | 19.81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 13.1
- value
- 2.6
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- 5.4
- value
- 1.5
- group Id
- OG002
- lower Limit
- 0.1
- upper Limit
- 6.2
- value
- 1.4
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 26.5
- value
- 3.6
- group Id
- OG004
- lower Limit
- 0.5
- upper Limit
- 2.3
- value
- 1.1
- group Id
- OG005
- lower Limit
- 0.7
- upper Limit
- 1.4
- value
- 1.4
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 40.4
- value
- 8.0
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 22.7
- value
- 3.4
- group Id
- OG008
- lower Limit
- 0.03
- upper Limit
- 15.44
- value
- 4.1
- group Id
- OG009
- lower Limit
- 0.03
- upper Limit
- 19.81
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 13
- group Id
- OG008
- value
- 43
- group Id
- OG009
- value
- 44
- units
- Participants
- description
- PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
- 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. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analysis.
- 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: Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice