NCT03416374 · OUTCOME
Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27
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 and End of Treatment (Up to 23 cycles for VRd Group, Up to 32 cycles for KRd and Overall Group, each cycle was of 28 days)
What was measured
EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.
Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
Groups in this outcome
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
[Overall]; Combination Therapy + Ixazomib Therapy
Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
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 |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 39 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 45 |
|---|
Reported measurements
Disease Symptoms: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 39 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 45 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 24.07 | 21.564 | Not reported | Not reported | Not reported |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 19.23 | 16.756 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 19.88 | 17.266 | Not reported | Not reported | Not reported |
|---|
Disease Symptoms: Cycle 23
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 1 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 7 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 | NA | Not reported | Not reported | Number of participants analyzed was one. |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 4.63 | 7.384 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 3.97 | 6.964 | Not reported | Not reported | Not reported |
|---|
Disease Symptoms: Cycle 32
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 2 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 2 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 2.78 | 3.928 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 2.78 | 3.928 | Not reported | Not reported | Not reported |
|---|
Side-Effects of Treatment: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 39 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 45 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 16.67 | 12.776 | Not reported | Not reported | Not reported |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 16.60 | 14.464 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 16.61 | 14.115 | Not reported | Not reported | Not reported |
|---|
Side-Effects of Treatment: Cycle 23
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 1 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 7 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 3.70 | NA | Not reported | Not reported | Number of participants analyzed was one. |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 16.05 | 3.825 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 14.29 | 5.828 | Not reported | Not reported | Not reported |
|---|
Side-Effects of Treatment: Cycle 32
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 2 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 2 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 18.52 | 15.713 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 18.52 | 15.713 | Not reported | Not reported | Not reported |
|---|
Body Image: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 39 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 45 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 44.44 | 45.542 | Not reported | Not reported | Not reported |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 23.08 | 26.660 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 25.93 | 30.058 | Not reported | Not reported | Not reported |
|---|
Body Image: Cycle 23
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 1 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 7 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 | NA | Not reported | Not reported | Number of participants analyzed was one. |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 16.67 | 18.257 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 14.29 | 17.817 | Not reported | Not reported | Not reported |
|---|
Body Image: Cycle 32
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 2 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 2 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 16.67 | 23.570 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 16.67 | 23.570 | Not reported | Not reported | Not reported |
|---|
Future Perspective: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 39 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 45 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 66.67 | 37.185 | Not reported | Not reported | Not reported |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 44.16 | 24.114 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 47.16 | 26.817 | Not reported | Not reported | Not reported |
|---|
Future Perspective: Cycle 23
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 1 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 6 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 7 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 11.11 | NA | Not reported | Not reported | Number of participants analyzed was one. |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 35.19 | 8.364 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 31.75 | 11.878 | Not reported | Not reported | Not reported |
|---|
Future Perspective: Cycle 32
Analysis denominator · Participants
| Group | Source count |
|---|
| [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy | 0 |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 2 |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 2 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy | 27.78 | 7.857 | Not reported | Not reported | Not reported |
|---|
| [Overall]; Combination Therapy + Ixazomib Therapy | 27.78 | 7.857 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.564
- value
- 24.07
- group Id
- OG001
- spread
- 16.756
- value
- 19.23
- group Id
- OG002
- spread
- 17.266
- value
- 19.88
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 45
- units
- Participants
- title
- Disease Symptoms: Baseline
- categories
- measurements
- comment
- Number of participants analyzed was one.
- group Id
- OG000
- spread
- NA
- value
- 0
- group Id
- OG001
- spread
- 7.384
- value
- 4.63
- group Id
- OG002
- spread
- 6.964
- value
- 3.97
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Disease Symptoms: Cycle 23
- categories
- measurements
- group Id
- OG001
- spread
- 3.928
- value
- 2.78
- group Id
- OG002
- spread
- 3.928
- value
- 2.78
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Disease Symptoms: Cycle 32
- categories
- measurements
- group Id
- OG000
- spread
- 12.776
- value
- 16.67
- group Id
- OG001
- spread
- 14.464
- value
- 16.60
- group Id
- OG002
- spread
- 14.115
- value
- 16.61
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 45
- units
- Participants
- title
- Side-Effects of Treatment: Baseline
- categories
- measurements
- comment
- Number of participants analyzed was one.
- group Id
- OG000
- spread
- NA
- value
- 3.70
- group Id
- OG001
- spread
- 3.825
- value
- 16.05
- group Id
- OG002
- spread
- 5.828
- value
- 14.29
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Side-Effects of Treatment: Cycle 23
- categories
- measurements
- group Id
- OG001
- spread
- 15.713
- value
- 18.52
- group Id
- OG002
- spread
- 15.713
- value
- 18.52
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Side-Effects of Treatment: Cycle 32
- categories
- measurements
- group Id
- OG000
- spread
- 45.542
- value
- 44.44
- group Id
- OG001
- spread
- 26.660
- value
- 23.08
- group Id
- OG002
- spread
- 30.058
- value
- 25.93
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 45
- units
- Participants
- title
- Body Image: Baseline
- categories
- measurements
- comment
- Number of participants analyzed was one.
- group Id
- OG000
- spread
- NA
- value
- 0
- group Id
- OG001
- spread
- 18.257
- value
- 16.67
- group Id
- OG002
- spread
- 17.817
- value
- 14.29
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Body Image: Cycle 23
- categories
- measurements
- group Id
- OG001
- spread
- 23.570
- value
- 16.67
- group Id
- OG002
- spread
- 23.570
- value
- 16.67
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Body Image: Cycle 32
- categories
- measurements
- group Id
- OG000
- spread
- 37.185
- value
- 66.67
- group Id
- OG001
- spread
- 24.114
- value
- 44.16
- group Id
- OG002
- spread
- 26.817
- value
- 47.16
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 45
- units
- Participants
- title
- Future Perspective: Baseline
- categories
- measurements
- comment
- Number of participants analyzed was one.
- group Id
- OG000
- spread
- NA
- value
- 11.11
- group Id
- OG001
- spread
- 8.364
- value
- 35.19
- group Id
- OG002
- spread
- 11.878
- value
- 31.75
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Future Perspective: Cycle 23
- categories
- measurements
- group Id
- OG001
- spread
- 7.857
- value
- 27.78
- group Id
- OG002
- spread
- 7.857
- value
- 27.78
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Future Perspective: Cycle 32
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 45
- units
- Participants
- description
- EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.
- dispersion Type
- Standard Deviation
- groups
- description
- Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
- id
- OG000
- title
- [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
- description
- Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
- id
- OG001
- title
- [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
- description
- Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
- id
- OG002
- title
- [Overall]; Combination Therapy + Ixazomib Therapy
- param Type
- MEAN
- population Description
- Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
- reporting Status
- POSTED
- time Frame
- Baseline and End of Treatment (Up to 23 cycles for VRd Group, Up to 32 cycles for KRd and Overall Group, each cycle was of 28 days)
- title
- Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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