NCT01881789 · OUTCOME
Plasma Oprozomib Concentration
Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma · Source last updated 2022-11-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 day 1 at 1 to 2.5 hours and 2.75 to 5 hours after end of infusion (EOI) and cycle 3 day 1 at predose and 1 to 2.5 hours and 2.75 to 5 hours after EOI.
What was measured
Plasma samples for oprozomib concentration assays were only collected for participants in the 5/14 dosing schedule groups.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry.
Analysis population: Participants in the 5/14 dosing schedule groups with available concentration data
Groups in this outcome
Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
|---|
Reported measurements
Cycle 1 day 1, 1 - 2.5 hours post EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 497 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 632 | 657 | Not reported | Not reported | Not reported |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 697 | 435 | Not reported | Not reported | Not reported |
|---|
Cycle 1 day 1, 2.75 - 5 hours post EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 299 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 15.8 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 78.0 | 48.9 | Not reported | Not reported | Not reported |
|---|
Cycle 3 day 1, predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 1 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 142 | 285 | Not reported | Not reported | Not reported |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 0.0 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
Cycle 3 day 1, 1 - 2.5 hours post EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 1 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 111 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 175 | 303 | Not reported | Not reported | Not reported |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 178 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
Cycle 3 day 1, 2.75 - 5 hours post EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 1 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2.00 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 255 | 323 | Not reported | Not reported | Not reported |
|---|
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 69.1 | NA | Not reported | Not reported | Standard deviation not calculated when N ≤ 2 |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG000
- spread
- NA
- value
- 497
- group Id
- OG001
- spread
- 657
- value
- 632
- group Id
- OG002
- spread
- 435
- value
- 697
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- Cycle 1 day 1, 1 - 2.5 hours post EOI
- categories
- measurements
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG000
- spread
- NA
- value
- 299
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG001
- spread
- NA
- value
- 15.8
- group Id
- OG002
- spread
- 48.9
- value
- 78.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- Cycle 1 day 1, 2.75 - 5 hours post EOI
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- spread
- 285
- value
- 142
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG002
- spread
- NA
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Cycle 3 day 1, predose
- categories
- measurements
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG000
- spread
- NA
- value
- 111
- group Id
- OG001
- spread
- 303
- value
- 175
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG002
- spread
- NA
- value
- 178
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Cycle 3 day 1, 1 - 2.5 hours post EOI
- categories
- measurements
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG000
- spread
- NA
- value
- 2.00
- group Id
- OG001
- spread
- 323
- value
- 255
- comment
- Standard deviation not calculated when N ≤ 2
- group Id
- OG002
- spread
- NA
- value
- 69.1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Cycle 3 day 1, 2.75 - 5 hours post EOI
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Plasma samples for oprozomib concentration assays were only collected for participants in the 5/14 dosing schedule groups.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG000
- title
- Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG001
- title
- Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
- id
- OG002
- title
- Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone
- param Type
- MEAN
- population Description
- Participants in the 5/14 dosing schedule groups with available concentration data
- reporting Status
- POSTED
- time Frame
- Cycle 1 day 1 at 1 to 2.5 hours and 2.75 to 5 hours after end of infusion (EOI) and cycle 3 day 1 at predose and 1 to 2.5 hours and 2.75 to 5 hours after EOI.
- title
- Plasma Oprozomib Concentration
- type
- SECONDARY
- unit Of Measure
- ng/mL
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