NCT02990338 · OUTCOME
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17
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, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
What was measured
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
Analysis population: Analysis was performed on safety population evaluable for health state utility index. Here, 'Number analyzed' = participants with available data for each specified category.
Groups in this outcome
Pd (Pomalidomide + Dexamethasone)
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
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 |
|---|
| Pd (Pomalidomide + Dexamethasone) | 134 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 140 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 134 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 138 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 0.70 | 0.24 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.71 | 0.21 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 109 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 125 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -0.01 | 0.22 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -0.01 | 0.22 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 69 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 101 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 0.02 | 0.22 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -0.00 | 0.20 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 55 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 82 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -0.03 | 0.27 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -0.01 | 0.15 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 10 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -0.02 | 0.19 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -0.01 | 0.23 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.24
- value
- 0.70
- group Id
- OG001
- spread
- 0.21
- value
- 0.71
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.22
- value
- -0.01
- group Id
- OG001
- spread
- 0.22
- value
- -0.01
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 125
- units
- Participants
- title
- Day 1: Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 0.22
- value
- 0.02
- group Id
- OG001
- spread
- 0.20
- value
- -0.00
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 101
- units
- Participants
- title
- Day 1: Cycle 6
- categories
- measurements
- group Id
- OG000
- spread
- 0.27
- value
- -0.03
- group Id
- OG001
- spread
- 0.15
- value
- -0.01
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 82
- units
- Participants
- title
- Day 1: Cycle 9
- categories
- measurements
- group Id
- OG000
- spread
- 0.19
- value
- -0.02
- group Id
- OG001
- spread
- 0.23
- value
- -0.01
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Day 1: Cycle 17
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
- id
- OG000
- title
- Pd (Pomalidomide + Dexamethasone)
- description
- Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
- id
- OG001
- title
- IPd (Isatuximab + Pomalidomide + Dexamethasone)
- param Type
- MEAN
- population Description
- Analysis was performed on safety population evaluable for health state utility index. Here, 'Number analyzed' = participants with available data for each specified category.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
- title
- Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value
- type
- SECONDARY
- unit Of Measure
- score on a scale
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