TriangleNCT01241292 · OUTCOME
Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- µg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
What was measured
The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.
Analysis population: All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.
Groups in this outcome
Elotuzumab 10 mg/kg
Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
Elotuzumab 20 mg/kg
Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
| Group | Source count |
|---|---|
| Elotuzumab 10 mg/kg | 3 |
| Elotuzumab 20 mg/kg | 3 |
Reported measurements
Cycle 1 Day 1 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 173 | 9 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 376 | 14 | Not reported | Not reported | Not reported |
Cycle 1 Day 8 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 237 | 19 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 549 | 18 | Not reported | Not reported | Not reported |
Cycle 1 Day 15 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 297 | 10 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 652 | 21 | Not reported | Not reported | Not reported |
Cycle 1 Day 22 (n=3,2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 234 | 14 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 724 | 45 | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 240 | 28 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 671 | 51 | Not reported | Not reported | Not reported |
Cycle 2 Day 22 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 270 | 32 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 844 | 26 | Not reported | Not reported | Not reported |
Cycle 3 Day 1 (n=3,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg | 286 | 32 | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg | 972 | 32 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9
- value
- 173
- group Id
- OG001
- spread
- 14
- value
- 376
- title
- Cycle 1 Day 1 (n=3,3)
- categories
- measurements
- group Id
- OG000
- spread
- 19
- value
- 237
- group Id
- OG001
- spread
- 18
- value
- 549
- title
- Cycle 1 Day 8 (n=3,3)
- categories
- measurements
- group Id
- OG000
- spread
- 10
- value
- 297
- group Id
- OG001
- spread
- 21
- value
- 652
- title
- Cycle 1 Day 15 (n=3,3)
- categories
- measurements
- group Id
- OG000
- spread
- 14
- value
- 234
- group Id
- OG001
- spread
- 45
- value
- 724
- title
- Cycle 1 Day 22 (n=3,2)
- categories
- measurements
- group Id
- OG000
- spread
- 28
- value
- 240
- group Id
- OG001
- spread
- 51
- value
- 671
- title
- Cycle 2 Day 1 (n=3,3)
- categories
- measurements
- group Id
- OG000
- spread
- 32
- value
- 270
- group Id
- OG001
- spread
- 26
- value
- 844
- title
- Cycle 2 Day 22 (n=3,3)
- categories
- measurements
- group Id
- OG000
- spread
- 32
- value
- 286
- group Id
- OG001
- spread
- 32
- value
- 972
- title
- Cycle 3 Day 1 (n=3,3)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
- id
- OG000
- title
- Elotuzumab 10 mg/kg
- description
- Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).
- id
- OG001
- title
- Elotuzumab 20 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.
- reporting Status
- POSTED
- time Frame
- Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
- title
- Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3
- type
- SECONDARY
- unit Of Measure
- µg/mL
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Preserved source evidence · Not medical advice