NCT01311687 · OUTCOME
Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
What was measured
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom).
Analysis population: PRO population with available data at Baseline and each time point.
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
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 |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 289 |
|---|
| High-Dose Dexamethasone | 144 |
|---|
Reported measurements
Cycle 2, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 218 |
|---|
| High-Dose Dexamethasone | 99 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 2.71 | 13.90 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 2.61 | 13.34 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 180 |
|---|
| High-Dose Dexamethasone | 55 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 3.26 | 13.72 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 5.35 | 12.27 | Not reported | Not reported | Not reported |
|---|
Cycle 4, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 161 |
|---|
| High-Dose Dexamethasone | 37 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 3.73 | 14.47 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 7.46 | 11.61 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 135 |
|---|
| High-Dose Dexamethasone | 30 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 4.74 | 14.45 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 6.89 | 10.32 | Not reported | Not reported | Not reported |
|---|
Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 115 |
|---|
| High-Dose Dexamethasone | 21 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 4.55 | 15.76 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 7.30 | 9.35 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.90
- value
- 2.71
- group Id
- OG001
- spread
- 13.34
- value
- 2.61
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 99
- units
- Participants
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 13.72
- value
- 3.26
- group Id
- OG001
- spread
- 12.27
- value
- 5.35
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 55
- units
- Participants
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 14.47
- value
- 3.73
- group Id
- OG001
- spread
- 11.61
- value
- 7.46
- denoms
- counts
- group Id
- OG000
- value
- 161
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 14.45
- value
- 4.74
- group Id
- OG001
- spread
- 10.32
- value
- 6.89
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 30
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 15.76
- value
- 4.55
- group Id
- OG001
- spread
- 9.35
- value
- 7.30
- denoms
- counts
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Cycle 6, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 144
- units
- Participants
- description
- The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
- id
- OG001
- title
- High-Dose Dexamethasone
- param Type
- MEAN
- population Description
- PRO population with available data at Baseline and each time point.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
- title
- Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle