NCT02990338 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score
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
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL
Analysis population: Analysis was performed on safety population evaluable for disease symptoms. 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) | 130 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 137 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 130 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 135 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 24.91 | 20.67 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 24.12 | 20.54 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 107 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 121 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -3.79 | 16.09 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -2.07 | 17.51 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 68 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 101 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -4.08 | 17.95 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -3.30 | 16.01 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 55 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 81 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -2.83 | 15.04 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -4.66 | 13.73 | 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) | -3.33 | 15.54 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.00 | 21.40 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.67
- value
- 24.91
- group Id
- OG001
- spread
- 20.54
- value
- 24.12
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 135
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 16.09
- value
- -3.79
- group Id
- OG001
- spread
- 17.51
- value
- -2.07
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 121
- units
- Participants
- title
- Day 1: Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 17.95
- value
- -4.08
- group Id
- OG001
- spread
- 16.01
- value
- -3.30
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 101
- units
- Participants
- title
- Day 1: Cycle 6
- categories
- measurements
- group Id
- OG000
- spread
- 15.04
- value
- -2.83
- group Id
- OG001
- spread
- 13.73
- value
- -4.66
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 81
- units
- Participants
- title
- Day 1: Cycle 9
- categories
- measurements
- group Id
- OG000
- spread
- 15.54
- value
- -3.33
- group Id
- OG001
- spread
- 21.40
- value
- 0.00
- 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
- 130
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL
- 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 disease symptoms. 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 Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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