NCT01564537 · OUTCOME
Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)
A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10
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, EOT and follow-up (up to approximately 97 months)
What was measured
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning.
Analysis population: ITT population included all randomized participants. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.
Groups in this outcome
Ixazomib+ Lenalidomide + Dexamethasone
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
Placebo + Lenalidomide + Dexamethasone
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
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 |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 354 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 359 |
|---|
Reported measurements
Disease Symptoms: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 354 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 359 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 29.71 | 20.850 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | 30.41 | 23.072 | Not reported | Not reported | Not reported |
|---|
Disease Symptoms: EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 248 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 255 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | -2.35 | 20.752 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | -2.58 | 21.372 | Not reported | Not reported | Not reported |
|---|
Disease Symptoms: Last Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 1 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 0 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 1.11 | NA | Not reported | Not reported | The SD was not estimable due to single participant with event. |
|---|
Side Effects of Treatment: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 354 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 359 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 17.23 | 14.289 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | 17.97 | 14.682 | Not reported | Not reported | Not reported |
|---|
Side Effects of Treatment: EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 249 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 255 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 4.52 | 14.435 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | 4.43 | 13.955 | Not reported | Not reported | Not reported |
|---|
Side Effects of Treatment: Last Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 0 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 1 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Lenalidomide + Dexamethasone | 37.04 | NA | Not reported | Not reported | The SD was not estimable due to single participant with event. |
|---|
Body Image: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 353 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 359 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 78.00 | 29.259 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | 79.48 | 27.233 | Not reported | Not reported | Not reported |
|---|
Body Image: EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 245 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 254 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | -0.27 | 29.102 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | -5.38 | 29.368 | Not reported | Not reported | Not reported |
|---|
Body Image: Last Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 0 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 1 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Lenalidomide + Dexamethasone | -33.3 | NA | Not reported | Not reported | The SD was not estimable due to single participant with event. |
|---|
Future Perspective: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 353 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 359 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 56.99 | 25.170 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | 60.26 | 25.064 | Not reported | Not reported | Not reported |
|---|
Future Perspective: EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 248 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 255 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 2.76 | 22.90 | Not reported | Not reported | Not reported |
|---|
| Placebo + Lenalidomide + Dexamethasone | -2.75 | 22.842 | Not reported | Not reported | Not reported |
|---|
Future Perspective: Last Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 0 |
|---|
| Placebo + Lenalidomide + Dexamethasone | 1 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Lenalidomide + Dexamethasone | -11.11 | NA | Not reported | Not reported | The SD was not estimable due to single participant with event. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.850
- value
- 29.71
- group Id
- OG001
- spread
- 23.072
- value
- 30.41
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 359
- units
- Participants
- title
- Disease Symptoms: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 20.752
- value
- -2.35
- group Id
- OG001
- spread
- 21.372
- value
- -2.58
- denoms
- counts
- group Id
- OG000
- value
- 248
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Disease Symptoms: EOT
- categories
- measurements
- comment
- The SD was not estimable due to single participant with event.
- group Id
- OG000
- spread
- NA
- value
- 1.11
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Disease Symptoms: Last Follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 14.289
- value
- 17.23
- group Id
- OG001
- spread
- 14.682
- value
- 17.97
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 359
- units
- Participants
- title
- Side Effects of Treatment: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 14.435
- value
- 4.52
- group Id
- OG001
- spread
- 13.955
- value
- 4.43
- denoms
- counts
- group Id
- OG000
- value
- 249
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Side Effects of Treatment: EOT
- categories
- measurements
- comment
- The SD was not estimable due to single participant with event.
- group Id
- OG001
- spread
- NA
- value
- 37.04
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Side Effects of Treatment: Last Follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 29.259
- value
- 78.00
- group Id
- OG001
- spread
- 27.233
- value
- 79.48
- denoms
- counts
- group Id
- OG000
- value
- 353
- group Id
- OG001
- value
- 359
- units
- Participants
- title
- Body Image: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 29.102
- value
- -0.27
- group Id
- OG001
- spread
- 29.368
- value
- -5.38
- denoms
- counts
- group Id
- OG000
- value
- 245
- group Id
- OG001
- value
- 254
- units
- Participants
- title
- Body Image: EOT
- categories
- measurements
- comment
- The SD was not estimable due to single participant with event.
- group Id
- OG001
- spread
- NA
- value
- -33.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Body Image: Last Follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 25.170
- value
- 56.99
- group Id
- OG001
- spread
- 25.064
- value
- 60.26
- denoms
- counts
- group Id
- OG000
- value
- 353
- group Id
- OG001
- value
- 359
- units
- Participants
- title
- Future Perspective: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 22.90
- value
- 2.76
- group Id
- OG001
- spread
- 22.842
- value
- -2.75
- denoms
- counts
- group Id
- OG000
- value
- 248
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Future Perspective: EOT
- categories
- measurements
- comment
- The SD was not estimable due to single participant with event.
- group Id
- OG001
- spread
- NA
- value
- -11.11
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Future Perspective: Last Follow-up
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 359
- units
- Participants
- description
- The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning.
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
- id
- OG000
- title
- Ixazomib+ Lenalidomide + Dexamethasone
- description
- Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
- id
- OG001
- title
- Placebo + Lenalidomide + Dexamethasone
- param Type
- MEAN
- population Description
- ITT population included all randomized participants. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline, EOT and follow-up (up to approximately 97 months)
- title
- Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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