TriangleNCT03412565 · OUTCOME
D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From baseline up to 2 years 7 months
What was measured
DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Analysis population: Analysis population included number of responders (partial response or better) in each cohort. This secondary outcome measure was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts.
Groups in this outcome
D + Bortezomib + Melphalan + Prednisone (D-VMP)
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
| Group | Source count |
|---|---|
| D + Bortezomib + Melphalan + Prednisone (D-VMP) | 60 |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 61 |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 56 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| D + Bortezomib + Melphalan + Prednisone (D-VMP) | NA | Not reported | NA | NA | Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events. |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | NA | Not reported | NA | NA | Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events. |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | NA | Not reported | NA | NA | Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 56
- units
- Participants
- description
- DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
- dispersion Type
- Full Range
- groups
- description
- Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.
- id
- OG000
- title
- D + Bortezomib + Melphalan + Prednisone (D-VMP)
- description
- Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
- id
- OG001
- title
- Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
- description
- Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
- id
- OG002
- title
- Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
- param Type
- MEDIAN
- population Description
- Analysis population included number of responders (partial response or better) in each cohort. This secondary outcome measure was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts.
- reporting Status
- POSTED
- time Frame
- From baseline up to 2 years 7 months
- title
- D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice