TriangleNCT03215030 · OUTCOME
Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
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, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)
What was measured
EORTC QLQ-MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image).
Analysis population: The PRO Analysis Set included all participants with a baseline and at least one post-baseline measurement of any PRO measure (EORTC QLQ-MY20 or EQ-5D-5L). Overall number of participants analyzed is the number of participants with data available for analyses.
Groups in this outcome
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 7 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 6 |
Reported measurements
Disease Symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | -7.9 | 22.63 | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | -7.4 | 10.93 | Not reported | Not reported | Not reported |
Side Effects of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 4.7 | 11.62 | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 7.0 | 5.45 | Not reported | Not reported | Not reported |
Body Image
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 4.8 | 35.63 | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 0.0 | 21.06 | Not reported | Not reported | Not reported |
Future Perspective
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 11.1 | 9.06 | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 7.4 | 34.92 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.63
- value
- -7.9
- group Id
- OG001
- spread
- 10.93
- value
- -7.4
- title
- Disease Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 11.62
- value
- 4.7
- group Id
- OG001
- spread
- 5.45
- value
- 7.0
- title
- Side Effects of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 35.63
- value
- 4.8
- group Id
- OG001
- spread
- 21.06
- value
- 0.0
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- spread
- 9.06
- value
- 11.1
- group Id
- OG001
- spread
- 34.92
- value
- 7.4
- title
- Future Perspective
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- EORTC QLQ-MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG000
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG001
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- MEAN
- population Description
- The PRO Analysis Set included all participants with a baseline and at least one post-baseline measurement of any PRO measure (EORTC QLQ-MY20 or EQ-5D-5L). Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)
- title
- Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice