NCT03859427 · OUTCOME
Change From Baseline in EORTC QLQ-C30 Role Functioning Scale
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-08-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)
What was measured
The QLQ-C30 role function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the role functioning score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.
Analysis population: The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint.
Groups in this outcome
Twice-weekly KRd 20/27 mg/m^2
Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
Once-weekly KRd 20/56 mg/m^2
Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
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 KRd 20/27 mg/m^2 | 226 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 228 |
|---|
Reported measurements
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 186 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 182 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -4.30 | 26.16 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | -2.47 | 24.81 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 181 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 177 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -2.67 | 25.77 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | -3.11 | 24.32 | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 162 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 161 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -3.29 | 26.19 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 1.76 | 24.34 | Not reported | Not reported | Not reported |
|---|
Cycle 9 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 152 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 148 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -0.88 | 23.24 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 2.70 | 24.90 | Not reported | Not reported | Not reported |
|---|
Cycle 12 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 134 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 132 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -0.25 | 23.21 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 1.64 | 28.97 | Not reported | Not reported | Not reported |
|---|
Safety Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | 146 |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 145 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly KRd 20/27 mg/m^2 | -2.28 | 24.73 | Not reported | Not reported | Not reported |
|---|
| Once-weekly KRd 20/56 mg/m^2 | 3.68 | 26.24 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -1.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.72
- estimate Comment
- Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 1.73
Complete source fields
- analyses
- ci Lower Limit
- -1.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.72
- estimate Comment
- Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 1.73
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.16
- value
- -4.30
- group Id
- OG001
- spread
- 24.81
- value
- -2.47
- denoms
- counts
- group Id
- OG000
- value
- 186
- group Id
- OG001
- value
- 182
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 25.77
- value
- -2.67
- group Id
- OG001
- spread
- 24.32
- value
- -3.11
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 177
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 26.19
- value
- -3.29
- group Id
- OG001
- spread
- 24.34
- value
- 1.76
- denoms
- counts
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 23.24
- value
- -0.88
- group Id
- OG001
- spread
- 24.90
- value
- 2.70
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 148
- units
- Participants
- title
- Cycle 9 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 23.21
- value
- -0.25
- group Id
- OG001
- spread
- 28.97
- value
- 1.64
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 132
- units
- Participants
- title
- Cycle 12 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 24.73
- value
- -2.28
- group Id
- OG001
- spread
- 26.24
- value
- 3.68
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 145
- units
- Participants
- title
- Safety Follow-up
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- The QLQ-C30 role function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the role functioning score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.
- dispersion Type
- Standard Deviation
- groups
- description
- Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG000
- title
- Twice-weekly KRd 20/27 mg/m^2
- description
- Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG001
- title
- Once-weekly KRd 20/56 mg/m^2
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint.
- reporting Status
- POSTED
- time Frame
- Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)
- title
- Change From Baseline in EORTC QLQ-C30 Role Functioning Scale
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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