NCT02412878 · OUTCOME
Plasma Carfilzomib Concentration During Cycle 2
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma · Source last updated 2022-09-23
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 2 day 1 predose, 15 minutes after the start of infusion (once-weekly carfilzomib only), end of infusion, and 30 minutes after the end of infusion
What was measured
Concentrations of carfilzomib in plasma were measured using a validated assay method. The lower limit of quantification was 0.100 ng/mL.
Analysis population: Participants at a subset of sites who participated in the sparse pharmacokinetic sampling, with available data at each time point.
Groups in this outcome
Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
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 |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 36 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 55 |
|---|
Reported measurements
Predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 36 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 55 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 36.2 | 162 | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 203 | 1380 | Not reported | Not reported | Not reported |
|---|
15 minutes after start of infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 0 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 46 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 1370 | 1410 | Not reported | Not reported | Not reported |
|---|
End of infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 10 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 51 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 1640 | 1900 | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 1130 | 928 | Not reported | Not reported | Not reported |
|---|
30 minutes after end of infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 27 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 46 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 104 | 293 | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 480 | 2300 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 162
- value
- 36.2
- group Id
- OG001
- spread
- 1380
- value
- 203
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 55
- units
- Participants
- title
- Predose
- categories
- measurements
- group Id
- OG001
- spread
- 1410
- value
- 1370
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 46
- units
- Participants
- title
- 15 minutes after start of infusion
- categories
- measurements
- group Id
- OG000
- spread
- 1900
- value
- 1640
- group Id
- OG001
- spread
- 928
- value
- 1130
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 51
- units
- Participants
- title
- End of infusion
- categories
- measurements
- group Id
- OG000
- spread
- 293
- value
- 104
- group Id
- OG001
- spread
- 2300
- value
- 480
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 46
- units
- Participants
- title
- 30 minutes after end of infusion
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Concentrations of carfilzomib in plasma were measured using a validated assay method. The lower limit of quantification was 0.100 ng/mL.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG000
- title
- Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
- description
- Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG001
- title
- Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
- param Type
- MEAN
- population Description
- Participants at a subset of sites who participated in the sparse pharmacokinetic sampling, with available data at each time point.
- reporting Status
- POSTED
- time Frame
- Cycle 2 day 1 predose, 15 minutes after the start of infusion (once-weekly carfilzomib only), end of infusion, and 30 minutes after the end of infusion
- title
- Plasma Carfilzomib Concentration During Cycle 2
- type
- SECONDARY
- unit Of Measure
- ng/mL
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