TriangleNCT05556616 · OUTCOME
Groups 2 and 3: Disease Control Rate (DCR)
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 16.7 months
What was measured
DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
Analysis population: The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here.
Groups in this outcome
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
| Group | Source count |
|---|---|
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 4 |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 4 |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 75.0 | Not reported | 19.41 | 99.37 | Not reported |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 50.0 | Not reported | 6.76 | 93.24 | Not reported |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 66.7 | Not reported | 9.43 | 99.16 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.41
- upper Limit
- 99.37
- value
- 75.0
- group Id
- OG001
- lower Limit
- 6.76
- upper Limit
- 93.24
- value
- 50.0
- group Id
- OG002
- lower Limit
- 9.43
- upper Limit
- 99.16
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
- id
- OG000
- title
- Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
- description
- Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
- id
- OG001
- title
- Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
- description
- Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
- id
- OG002
- title
- Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
- param Type
- NUMBER
- population Description
- The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here.
- reporting Status
- POSTED
- time Frame
- Up to 16.7 months
- title
- Groups 2 and 3: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice