TriangleNCT03871829 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to 3 years and 7 months
What was measured
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Analysis population: ITT analysis set included all participants who were randomized in the study. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Groups in this outcome
Arm A: Carfilzomib+Dexamethasone (Kd)
Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
Arm B: Dara-SC in Combination With Kd (DKd)
Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
| Group | Source count |
|---|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 12 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | NA | Not reported | 25.40 | NA | Mean and upper limit of 90% CI were not estimable due to insufficient number of events. |
| Arm B: Dara-SC in Combination With Kd (DKd) | NA | Not reported | 27.10 | NA | Mean and upper limit of 90% CI were not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Mean and upper limit of 90% CI were not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 25.40
- upper Limit
- NA
- value
- NA
- comment
- Mean and upper limit of 90% CI were not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 27.10
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
- id
- OG000
- title
- Arm A: Carfilzomib+Dexamethasone (Kd)
- description
- Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
- id
- OG001
- title
- Arm B: Dara-SC in Combination With Kd (DKd)
- param Type
- MEDIAN
- population Description
- ITT analysis set included all participants who were randomized in the study. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 3 years and 7 months
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice