TriangleNCT03512353 · OUTCOME
Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment
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
- Baseline (cycle 1 day 1) and cycles 2 - 6
What was measured
EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'. The QLQ-MY20 includes four domains (Disease Symptoms, Side-effects of Treatment, Body Image and Future Perspective). Domain scores are calculated as averages and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement. Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.
Analysis population: Enrolled participants who completed 12 cycles of treatment
Groups in this outcome
Carfilzomib Plus Dexamethasone
Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
| Group | Source count |
|---|---|
| Carfilzomib Plus Dexamethasone | 3 |
Reported measurements
Disease Symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | -13.2 | 16.4 | Not reported | Not reported | Not reported |
Side-effects of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 10.6 | 6.8 | Not reported | Not reported | Not reported |
Body Image
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | -2.8 | 4.8 | Not reported | Not reported | Not reported |
Future Perspective
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 6.1 | 25.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.4
- value
- -13.2
- title
- Disease Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 6.8
- value
- 10.6
- title
- Side-effects of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 4.8
- value
- -2.8
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- spread
- 25.3
- value
- 6.1
- title
- Future Perspective
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'. The QLQ-MY20 includes four domains (Disease Symptoms, Side-effects of Treatment, Body Image and Future Perspective). Domain scores are calculated as averages and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement. Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
- id
- OG000
- title
- Carfilzomib Plus Dexamethasone
- param Type
- MEAN
- population Description
- Enrolled participants who completed 12 cycles of treatment
- reporting Status
- POSTED
- time Frame
- Baseline (cycle 1 day 1) and cycles 2 - 6
- title
- Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice