NCT01080391 · OUTCOME
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma · Source last updated 2022-09-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
What was measured
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Analysis population: ITT analysis set participants with a baseline value.
Groups in this outcome
Lenalidomide and Dexamethasone (Rd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
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 |
|---|
| Lenalidomide and Dexamethasone (Rd) | 367 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 375 |
|---|
Reported measurements
Cycle 1 Day 1 (Baseline)
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and Dexamethasone (Rd) | 367 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 375 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and Dexamethasone (Rd) | 58.1 | 21.7 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 58.3 | 21.7 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and Dexamethasone (Rd) | 334 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 356 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and Dexamethasone (Rd) | 56.8 | 19.4 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 59.9 | 20.4 | Not reported | Not reported | Not reported |
|---|
Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and Dexamethasone (Rd) | 284 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 326 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and Dexamethasone (Rd) | 58.9 | 19.7 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 62.5 | 20.1 | Not reported | Not reported | Not reported |
|---|
Cycle 12, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and Dexamethasone (Rd) | 212 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 255 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and Dexamethasone (Rd) | 57.3 | 19.7 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 62.7 | 19.6 | Not reported | Not reported | Not reported |
|---|
Cycle 18, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and Dexamethasone (Rd) | 147 |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 226 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and Dexamethasone (Rd) | 59.9 | 18.8 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 64.3 | 19.2 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.7
- value
- 58.1
- group Id
- OG001
- spread
- 21.7
- value
- 58.3
- denoms
- counts
- group Id
- OG000
- value
- 367
- group Id
- OG001
- value
- 375
- units
- Participants
- title
- Cycle 1 Day 1 (Baseline)
- categories
- measurements
- group Id
- OG000
- spread
- 19.4
- value
- 56.8
- group Id
- OG001
- spread
- 20.4
- value
- 59.9
- denoms
- counts
- group Id
- OG000
- value
- 334
- group Id
- OG001
- value
- 356
- units
- Participants
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.7
- value
- 58.9
- group Id
- OG001
- spread
- 20.1
- value
- 62.5
- denoms
- counts
- group Id
- OG000
- value
- 284
- group Id
- OG001
- value
- 326
- units
- Participants
- title
- Cycle 6, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.7
- value
- 57.3
- group Id
- OG001
- spread
- 19.6
- value
- 62.7
- denoms
- counts
- group Id
- OG000
- value
- 212
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Cycle 12, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 18.8
- value
- 59.9
- group Id
- OG001
- spread
- 19.2
- value
- 64.3
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 226
- units
- Participants
- title
- Cycle 18, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 367
- group Id
- OG001
- value
- 375
- units
- Participants
- description
- Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
- id
- OG000
- title
- Lenalidomide and Dexamethasone (Rd)
- description
- Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
- id
- OG001
- title
- Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
- param Type
- MEAN
- population Description
- ITT analysis set participants with a baseline value.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
- title
- Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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