NCT02990338 · OUTCOME
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)
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
- centimeter
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
What was measured
EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Analysis population: Analysis was performed on safety population evaluable for visual analogue scale. 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 centimeter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 65.38 | 19.31 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 66.62 | 19.32 | 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 centimeter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 0.26 | 17.37 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.92 | 19.41 | 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 centimeter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 2.49 | 18.83 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 1.19 | 17.70 | 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 centimeter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 4.42 | 19.78 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 1.96 | 16.60 | 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 centimeter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -1.70 | 12.39 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -3.00 | 12.58 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.31
- value
- 65.38
- group Id
- OG001
- spread
- 19.32
- value
- 66.62
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 17.37
- value
- 0.26
- group Id
- OG001
- spread
- 19.41
- value
- 0.92
- 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
- 18.83
- value
- 2.49
- group Id
- OG001
- spread
- 17.70
- value
- 1.19
- 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
- 19.78
- value
- 4.42
- group Id
- OG001
- spread
- 16.60
- value
- 1.96
- 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
- 12.39
- value
- -1.70
- group Id
- OG001
- spread
- 12.58
- value
- -3.00
- 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
- EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable 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 visual analogue scale. 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, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)
- type
- SECONDARY
- unit Of Measure
- centimeter
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Preserved source evidence · Not medical advice
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