TriangleNCT03412565 · OUTCOME
D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
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 2 years and 3 months
What was measured
MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.
Analysis population: All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only.
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) | 67 |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 65 |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 66 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| D + Bortezomib + Melphalan + Prednisone (D-VMP) | 25.4 | Not reported | 16.9 | 35.6 | Not reported |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 21.5 | Not reported | 13.5 | 31.6 | Not reported |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 27.3 | Not reported | 18.4 | 37.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.9
- upper Limit
- 35.6
- value
- 25.4
- group Id
- OG001
- lower Limit
- 13.5
- upper Limit
- 31.6
- value
- 21.5
- group Id
- OG002
- lower Limit
- 18.4
- upper Limit
- 37.7
- value
- 27.3
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 66
- units
- Participants
- description
- MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.
- dispersion Type
- 90% Confidence Interval
- 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
- NUMBER
- population Description
- All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only.
- reporting Status
- POSTED
- time Frame
- Up to 2 years and 3 months
- title
- D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice