TriangleNCT05556616 · OUTCOME
Overall Response Rate (ORR)
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
ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of 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 criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
Analysis population: Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline \& at least 1 post-baseline efficacy evaluation.
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 | 0 | Not reported | 0.00 | 60.24 | Not reported |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 50 | Not reported | 6.76 | 93.24 | Not reported |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 33.3 | Not reported | 0.84 | 90.57 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 60.24
- value
- 0
- group Id
- OG001
- lower Limit
- 6.76
- upper Limit
- 93.24
- value
- 50
- group Id
- OG002
- lower Limit
- 0.84
- upper Limit
- 90.57
- value
- 33.3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of 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 criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
- 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
- Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline \& at least 1 post-baseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Up to 16.7 months
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice