TriangleNCT03215030 · OUTCOME
Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 20.5 months in Part 3
What was measured
MRD negativity rate at a sensitivity of 10\^-5 was defined as participants who were MRD negative at a sensitivity of 10\^-5 in participants achieving suspected complete response (CR). CR was defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria was required.
Analysis population: The Intent-to-Treat (ITT) Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
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 | 1 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- MRD negativity rate at a sensitivity of 10\^-5 was defined as participants who were MRD negative at a sensitivity of 10\^-5 in participants achieving suspected complete response (CR). CR was defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria was required.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The Intent-to-Treat (ITT) Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
- reporting Status
- POSTED
- time Frame
- Up to 20.5 months in Part 3
- title
- Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice