TriangleNCT03412565 · OUTCOME
Percentage of Participants With Anti-rHuPH20 Antibodies
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
- Not reported
- Time frame
- For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
What was measured
Percentage of participants with antibodies to rHuPH20 were reported.
Analysis population: Immunogenicity-evaluable analysis set for rHuPH20 is defined as all participants who received at least one dose of daratumumab SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of daratumumab SC).
Groups in this outcome
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
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 |
|---|---|
| Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 66 |
| D + Bortezomib + Melphalan + Prednisone (D-VMP) | 64 |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 62 |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 6.1 | Not reported | Not reported | Not reported | Not reported |
| D + Bortezomib + Melphalan + Prednisone (D-VMP) | 3.1 | Not reported | Not reported | Not reported | Not reported |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 4.8 | Not reported | Not reported | Not reported | Not reported |
| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 4.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6.1
- group Id
- OG001
- value
- 3.1
- group Id
- OG002
- value
- 4.8
- group Id
- OG003
- value
- 4.7
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 64
- units
- Participants
- description
- Percentage of participants with antibodies to rHuPH20 were reported.
- groups
- description
- Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
- id
- OG000
- title
- Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
- 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
- OG001
- 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
- OG002
- 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
- OG003
- title
- Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
- param Type
- NUMBER
- population Description
- Immunogenicity-evaluable analysis set for rHuPH20 is defined as all participants who received at least one dose of daratumumab SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of daratumumab SC).
- reporting Status
- POSTED
- time Frame
- For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
- title
- Percentage of Participants With Anti-rHuPH20 Antibodies
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice