TriangleNCT02685826 · OUTCOME
Lenalidomide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 15: Time to Maximum Observed Concentration (Tmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose
What was measured
Time to maximum observed concentration of Lenalidomide (LEN) after multiple doses on day 15 obtained from the observed concentration versus time data
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 | 18 |
| Cohort B: >=65 Years Old, TNE | 9 |
| Cohort C: High Risk, Post-transplant | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: High Risk, TNE | 2.000 | Not reported | 1.00 | 8.00 | Not reported |
| Cohort B: >=65 Years Old, TNE | 1.000 | Not reported | 0.55 | 2.00 | Not reported |
| Cohort C: High Risk, Post-transplant | 1.042 | Not reported | 0.47 | 4.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 8.00
- value
- 2.000
- group Id
- OG001
- lower Limit
- 0.55
- upper Limit
- 2.00
- value
- 1.000
- group Id
- OG002
- lower Limit
- 0.47
- upper Limit
- 4.00
- value
- 1.042
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 16
- units
- Participants
- description
- Time to maximum observed concentration of Lenalidomide (LEN) after multiple doses on day 15 obtained from the observed concentration versus time data
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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
- Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose
- title
- Lenalidomide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 15: Time to Maximum Observed Concentration (Tmax)
- type
- SECONDARY
- unit Of Measure
- hour
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Preserved source evidence · Not medical advice