NCT01818752 · OUTCOME
European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma · Source last updated 2019-08-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
What was measured
The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.
Analysis population: Intent-to treat population with available data at each time point.
Groups in this outcome
Bortezomib, Melphalan, Prednisone
Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Carfilzomib, Melphalan, Prednisone
Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
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 |
|---|
| Bortezomib, Melphalan, Prednisone | 477 |
|---|
| Carfilzomib, Melphalan, Prednisone | 478 |
|---|
Reported measurements
Baseline (n = 425, 425)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 53.3 | 21.9 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 53.9 | 22.5 | Not reported | Not reported | Not reported |
|---|
Week 6 (n = 412, 407)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 56.2 | 19.5 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 61.1 | 19.6 | Not reported | Not reported | Not reported |
|---|
Week 12 (n = 376, 389)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 55.3 | 19.8 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 62.4 | 17.7 | Not reported | Not reported | Not reported |
|---|
Week 18 (n = 341, 369)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 55.7 | 18.8 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 63.2 | 17.4 | Not reported | Not reported | Not reported |
|---|
Week 24 (n = 320, 345)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 57.3 | 17.6 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 63.3 | 17.1 | Not reported | Not reported | Not reported |
|---|
Week 30 (n = 298, 317)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 61.6 | 17.8 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 63.0 | 17.8 | Not reported | Not reported | Not reported |
|---|
Week 36 (n = 285, 308)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 61.9 | 17.5 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 64.0 | 18.1 | Not reported | Not reported | Not reported |
|---|
Week 42 (n = 275, 288)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 63.3 | 17.7 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 65.0 | 18.1 | Not reported | Not reported | Not reported |
|---|
Week 48 (n = 261, 265)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 62.9 | 18.4 | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 65.1 | 17.1 | 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
- 3.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.51
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.773
- group Description
- Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.0001
- p Value Comment
- Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.
- param Type
- Least squares mean difference
- param Value
- 4.99
- statistical Method
- Mixed Effects Model for Repeated Measure
Complete source fields
- analyses
- ci Lower Limit
- 3.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.51
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.773
- group Description
- Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.0001
- p Value Comment
- Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.
- param Type
- Least squares mean difference
- param Value
- 4.99
- statistical Method
- Mixed Effects Model for Repeated Measure
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.9
- value
- 53.3
- group Id
- OG001
- spread
- 22.5
- value
- 53.9
- title
- Baseline (n = 425, 425)
- categories
- measurements
- group Id
- OG000
- spread
- 19.5
- value
- 56.2
- group Id
- OG001
- spread
- 19.6
- value
- 61.1
- title
- Week 6 (n = 412, 407)
- categories
- measurements
- group Id
- OG000
- spread
- 19.8
- value
- 55.3
- group Id
- OG001
- spread
- 17.7
- value
- 62.4
- title
- Week 12 (n = 376, 389)
- categories
- measurements
- group Id
- OG000
- spread
- 18.8
- value
- 55.7
- group Id
- OG001
- spread
- 17.4
- value
- 63.2
- title
- Week 18 (n = 341, 369)
- categories
- measurements
- group Id
- OG000
- spread
- 17.6
- value
- 57.3
- group Id
- OG001
- spread
- 17.1
- value
- 63.3
- title
- Week 24 (n = 320, 345)
- categories
- measurements
- group Id
- OG000
- spread
- 17.8
- value
- 61.6
- group Id
- OG001
- spread
- 17.8
- value
- 63.0
- title
- Week 30 (n = 298, 317)
- categories
- measurements
- group Id
- OG000
- spread
- 17.5
- value
- 61.9
- group Id
- OG001
- spread
- 18.1
- value
- 64.0
- title
- Week 36 (n = 285, 308)
- categories
- measurements
- group Id
- OG000
- spread
- 17.7
- value
- 63.3
- group Id
- OG001
- spread
- 18.1
- value
- 65.0
- title
- Week 42 (n = 275, 288)
- categories
- measurements
- group Id
- OG000
- spread
- 18.4
- value
- 62.9
- group Id
- OG001
- spread
- 17.1
- value
- 65.1
- title
- Week 48 (n = 261, 265)
- denoms
- counts
- group Id
- OG000
- value
- 477
- group Id
- OG001
- value
- 478
- units
- Participants
- description
- The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG000
- title
- Bortezomib, Melphalan, Prednisone
- description
- Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG001
- title
- Carfilzomib, Melphalan, Prednisone
- param Type
- MEAN
- population Description
- Intent-to treat population with available data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
- title
- European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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