NCT01311687 · OUTCOME
Time to First Worsening of Quality of Life (QOL) Domains
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
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed on Day 1 of the first 6 treatment cycles.
What was measured
Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale.
Analysis population: PRO population
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
Global Health Status
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 71 | Not reported | 60 | 92 | Not reported |
|---|
| High-Dose Dexamethasone | 57 | Not reported | 36 | 91 | Not reported |
|---|
Physical Functioning
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 128 | Not reported | 92 | 225 | Not reported |
|---|
| High-Dose Dexamethasone | 67 | Not reported | 57 | 106 | Not reported |
|---|
Emotional Functioning
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 146 | Not reported | 120 | 259 | Not reported |
|---|
| High-Dose Dexamethasone | 85 | Not reported | 57 | 124 | Not reported |
|---|
Fatigue
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 58 | Not reported | 57 | 85 | Not reported |
|---|
| High-Dose Dexamethasone | 57 | Not reported | 46 | 67 | Not reported |
|---|
Pain
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 92 | Not reported | 86 | 147 | Not reported |
|---|
| High-Dose Dexamethasone | 85 | Not reported | 62 | 337 | Not reported |
|---|
Disease Symptoms
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 127 | Not reported | 92 | 155 | Not reported |
|---|
| High-Dose Dexamethasone | 106 | Not reported | 67 | 141 | Not reported |
|---|
Side Effects of Treatment
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 90 | Not reported | 78 | 123 | Not reported |
|---|
| High-Dose Dexamethasone | 85 | Not reported | 58 | 113 | Not reported |
|---|
Health Utility
Values in days · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 225 | Not reported | 123 | 338 | Not reported |
|---|
| High-Dose Dexamethasone | 162 | Not reported | 85 | NA | Could not be calculated due to a low number of events |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60
- upper Limit
- 92
- value
- 71
- group Id
- OG001
- lower Limit
- 36
- upper Limit
- 91
- value
- 57
- title
- Global Health Status
- categories
- measurements
- group Id
- OG000
- lower Limit
- 92
- upper Limit
- 225
- value
- 128
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 106
- value
- 67
- title
- Physical Functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 120
- upper Limit
- 259
- value
- 146
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 124
- value
- 85
- title
- Emotional Functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57
- upper Limit
- 85
- value
- 58
- group Id
- OG001
- lower Limit
- 46
- upper Limit
- 67
- value
- 57
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- lower Limit
- 86
- upper Limit
- 147
- value
- 92
- group Id
- OG001
- lower Limit
- 62
- upper Limit
- 337
- value
- 85
- title
- Pain
- categories
- measurements
- group Id
- OG000
- lower Limit
- 92
- upper Limit
- 155
- value
- 127
- group Id
- OG001
- lower Limit
- 67
- upper Limit
- 141
- value
- 106
- title
- Disease Symptoms
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78
- upper Limit
- 123
- value
- 90
- group Id
- OG001
- lower Limit
- 58
- upper Limit
- 113
- value
- 85
- title
- Side Effects of Treatment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 123
- upper Limit
- 338
- value
- 225
- comment
- Could not be calculated due to a low number of events
- group Id
- OG001
- lower Limit
- 85
- upper Limit
- NA
- value
- 162
- title
- Health Utility
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 144
- units
- Participants
- description
- Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- PRO population
- reporting Status
- POSTED
- time Frame
- Assessed on Day 1 of the first 6 treatment cycles.
- title
- Time to First Worsening of Quality of Life (QOL) Domains
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice
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