TriangleNCT03871829 · OUTCOME
Percentage of Participants Achieving Complete Response (CR) or Better
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
- 90% Confidence Interval
- Time frame
- Up to 3 years and 7 months
What was measured
Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and \<5% PCs in bone marrow.
Analysis population: The response-evaluable analysis set included participants who had confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit.
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) | 39 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 25.6 | Not reported | 14.6 | 39.6 | Not reported |
| Arm B: Dara-SC in Combination With Kd (DKd) | 12.2 | Not reported | 4.9 | 23.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.6
- upper Limit
- 39.6
- value
- 25.6
- group Id
- OG001
- lower Limit
- 4.9
- upper Limit
- 23.9
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and \<5% PCs in bone marrow.
- 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
- NUMBER
- population Description
- The response-evaluable analysis set included participants who had confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit.
- reporting Status
- POSTED
- time Frame
- Up to 3 years and 7 months
- title
- Percentage of Participants Achieving Complete Response (CR) or Better
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice