TriangleNCT03512353 · OUTCOME
Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 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
- Cycle 7 day 1 and cycles 8 - 12
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 treatments 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 was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 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 | 8.2 | 7.6 | Not reported | Not reported | Not reported |
Side-effects of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | -3.8 | 3.8 | Not reported | Not reported | Not reported |
Body Image
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | -17.8 | 20.4 | Not reported | Not reported | Not reported |
Future Perspective
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 3.0 | 7.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.6
- value
- 8.2
- title
- Disease Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 3.8
- value
- -3.8
- title
- Side-effects of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 20.4
- value
- -17.8
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- spread
- 7.1
- value
- 3.0
- 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 treatments 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 was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 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
- Cycle 7 day 1 and cycles 8 - 12
- title
- Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 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