TriangleNCT02335983 · OUTCOME
Change From Baseline in Bilirubin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- µmol/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Cycle 2 day 1
Analysis population: Participants in the safety analysis set with available data at each time point.
Groups in this outcome
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
| Group | Source count |
|---|---|
| RRMM Dose-evaluation: Carfilzomib 56 mg/m² | 10 |
| RRMM Dose-evaluation: Carfilzomib 70 mg/m² | 12 |
| RRMM Dose-expansion: Carfilzomib 70 mg/m² | 34 |
| NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² | 8 |
| NDMM Dose-expansion: Carfilzomib 70 mg/m² | 9 |
| NDMM Dose-expansion: Carfilzomib 56 mg/m² | 33 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| RRMM Dose-evaluation: Carfilzomib 56 mg/m² | 10 |
| RRMM Dose-evaluation: Carfilzomib 70 mg/m² | 12 |
| RRMM Dose-expansion: Carfilzomib 70 mg/m² | 34 |
| NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² | 8 |
| NDMM Dose-expansion: Carfilzomib 70 mg/m² | 9 |
| NDMM Dose-expansion: Carfilzomib 56 mg/m² | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose-evaluation: Carfilzomib 56 mg/m² | 8.55 | 3.78 | Not reported | Not reported | Not reported |
| RRMM Dose-evaluation: Carfilzomib 70 mg/m² | 9.98 | 4.72 | Not reported | Not reported | Not reported |
| RRMM Dose-expansion: Carfilzomib 70 mg/m² | 9.10 | 4.76 | Not reported | Not reported | Not reported |
| NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² | 10.26 | 4.38 | Not reported | Not reported | Not reported |
| NDMM Dose-expansion: Carfilzomib 70 mg/m² | 6.84 | 4.01 | Not reported | Not reported | Not reported |
| NDMM Dose-expansion: Carfilzomib 56 mg/m² | 7.16 | 3.29 | Not reported | Not reported | Not reported |
Change from Baseline to Cycle 2 Day 1
| Group | Source count |
|---|---|
| RRMM Dose-evaluation: Carfilzomib 56 mg/m² | 10 |
| RRMM Dose-evaluation: Carfilzomib 70 mg/m² | 12 |
| RRMM Dose-expansion: Carfilzomib 70 mg/m² | 32 |
| NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² | 8 |
| NDMM Dose-expansion: Carfilzomib 70 mg/m² | 7 |
| NDMM Dose-expansion: Carfilzomib 56 mg/m² | 31 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose-evaluation: Carfilzomib 56 mg/m² | 0.86 | 3.25 | Not reported | Not reported | Not reported |
| RRMM Dose-evaluation: Carfilzomib 70 mg/m² | 1.00 | 3.68 | Not reported | Not reported | Not reported |
| RRMM Dose-expansion: Carfilzomib 70 mg/m² | 1.34 | 3.52 | Not reported | Not reported | Not reported |
| NDMM Dose-evaluation: Carfilzomib 56/70 mg/m² | 3.42 | 5.56 | Not reported | Not reported | Not reported |
| NDMM Dose-expansion: Carfilzomib 70 mg/m² | 0.49 | 2.91 | Not reported | Not reported | Not reported |
| NDMM Dose-expansion: Carfilzomib 56 mg/m² | 1.21 | 3.10 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.78
- value
- 8.55
- group Id
- OG001
- spread
- 4.72
- value
- 9.98
- group Id
- OG002
- spread
- 4.76
- value
- 9.10
- group Id
- OG003
- spread
- 4.38
- value
- 10.26
- group Id
- OG004
- spread
- 4.01
- value
- 6.84
- group Id
- OG005
- spread
- 3.29
- value
- 7.16
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 32
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 3.25
- value
- 0.86
- group Id
- OG001
- spread
- 3.68
- value
- 1.00
- group Id
- OG002
- spread
- 3.52
- value
- 1.34
- group Id
- OG003
- spread
- 5.56
- value
- 3.42
- group Id
- OG004
- spread
- 2.91
- value
- 0.49
- group Id
- OG005
- spread
- 3.10
- value
- 1.21
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 31
- units
- Participants
- title
- Change from Baseline to Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 33
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG000
- title
- RRMM Dose-evaluation: Carfilzomib 56 mg/m²
- description
- Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG001
- title
- RRMM Dose-evaluation: Carfilzomib 70 mg/m²
- description
- Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG002
- title
- RRMM Dose-expansion: Carfilzomib 70 mg/m²
- description
- Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG003
- title
- NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
- description
- Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG004
- title
- NDMM Dose-expansion: Carfilzomib 70 mg/m²
- description
- Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
- id
- OG005
- title
- NDMM Dose-expansion: Carfilzomib 56 mg/m²
- param Type
- MEAN
- population Description
- Participants in the safety analysis set with available data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline and Cycle 2 day 1
- title
- Change From Baseline in Bilirubin
- type
- PRIMARY
- unit Of Measure
- µmol/L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice