TriangleNCT03215030 · OUTCOME
Parts 1 and 2: Clinical Benefit Rate (CBR)
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 54.3 months in Part 1; Up to 34.7 months in Part 2
What was measured
The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment 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. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
Analysis population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. 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.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A | 19 |
| Part 1 (Dose Escalation) Schedule B | 8 |
| Part 1 (Dose Escalation) Schedule C | 7 |
| Part 1 (Dose Escalation) Schedule D | 21 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 8 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 25 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 15.8 | Not reported | 3.38 | 39.58 | Not reported |
| Part 1 (Dose Escalation) Schedule B | 0 | Not reported | 0.00 | 36.94 | Not reported |
| Part 1 (Dose Escalation) Schedule C | 0 | Not reported | 0.00 | 40.96 | Not reported |
| Part 1 (Dose Escalation) Schedule D | 38.1 | Not reported | 18.11 | 61.56 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 0 | Not reported | 0.00 | 36.94 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 0 | Not reported | 0.00 | 70.76 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 52.0 | Not reported | 31.31 | 72.20 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 32.0 | Not reported | 14.95 | 53.50 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.38
- upper Limit
- 39.58
- value
- 15.8
- group Id
- OG001
- lower Limit
- 0.00
- upper Limit
- 36.94
- value
- 0
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 40.96
- value
- 0
- group Id
- OG003
- lower Limit
- 18.11
- upper Limit
- 61.56
- value
- 38.1
- group Id
- OG004
- lower Limit
- 0.00
- upper Limit
- 36.94
- value
- 0
- group Id
- OG005
- lower Limit
- 0.00
- upper Limit
- 70.76
- value
- 0
- group Id
- OG006
- lower Limit
- 31.31
- upper Limit
- 72.20
- value
- 52.0
- group Id
- OG007
- lower Limit
- 14.95
- upper Limit
- 53.50
- value
- 32.0
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 25
- group Id
- OG007
- value
- 25
- units
- Participants
- description
- The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment 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. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. 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
- title
- Parts 1 and 2: Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice