TriangleNCT02685826 · OUTCOME
Durvalumab (DURVA) Serum Pharmacokinetic (PK) Parameters in Cycle 1: Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-last)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*µg/L
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1
What was measured
Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100\*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.
Analysis population: The PK Population included participants who received \>=1 dose of study treatment and had \>=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.
Groups in this outcome
Cohort A: High Risk, TNE
High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
Cohort B: >=65 Years Old, TNE
\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
Cohort C: High Risk, Post-transplant
High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Cohort A: High Risk, TNE | 23 |
| Cohort B: >=65 Years Old, TNE | 10 |
| Cohort C: High Risk, Post-transplant | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: High Risk, TNE | 3535033.014 | 39.8 | Not reported | Not reported | Not reported |
| Cohort B: >=65 Years Old, TNE | 3582905.960 | 21.0 | Not reported | Not reported | Not reported |
| Cohort C: High Risk, Post-transplant | 4026520.655 | 39.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.8
- value
- 3535033.014
- group Id
- OG001
- spread
- 21.0
- value
- 3582905.960
- group Id
- OG002
- spread
- 39.1
- value
- 4026520.655
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 20
- units
- Participants
- description
- Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100\*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- Cohort A: High Risk, TNE
- description
- \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
- id
- OG001
- title
- Cohort B: >=65 Years Old, TNE
- description
- High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG002
- title
- Cohort C: High Risk, Post-transplant
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK Population included participants who received \>=1 dose of study treatment and had \>=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.
- reporting Status
- POSTED
- time Frame
- pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1
- title
- Durvalumab (DURVA) Serum Pharmacokinetic (PK) Parameters in Cycle 1: Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-last)
- type
- SECONDARY
- unit Of Measure
- day*µg/L
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Preserved source evidence · Not medical advice