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): Side Effects of Treatment 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. Side effects of treatment domain is one of the four domain scores. Side effects of treatment 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 side effects and lower HRQL and lower scores = less side effects and better HRQL.
Analysis population: Analysis was performed on safety population evaluable for side effects of treatment. 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) | 17.49 | 15.25 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 15.60 | 11.63 | 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) | 1.69 | 11.54 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 2.61 | 13.39 | 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) | -0.13 | 15.10 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 2.11 | 11.78 | 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) | 1.43 | 14.66 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 3.14 | 11.88 | 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) | -2.93 | 15.94 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 3.02 | 15.72 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.25
- value
- 17.49
- group Id
- OG001
- spread
- 11.63
- value
- 15.60
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 135
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 11.54
- value
- 1.69
- group Id
- OG001
- spread
- 13.39
- value
- 2.61
- 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
- 15.10
- value
- -0.13
- group Id
- OG001
- spread
- 11.78
- value
- 2.11
- 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
- 14.66
- value
- 1.43
- group Id
- OG001
- spread
- 11.88
- value
- 3.14
- 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
- 15.94
- value
- -2.93
- group Id
- OG001
- spread
- 15.72
- value
- 3.02
- 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. Side effects of treatment domain is one of the four domain scores. Side effects of treatment 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 side effects and lower HRQL and lower scores = less side effects and better 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 side effects of treatment. 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): Side Effects of Treatment 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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