NCT02990338 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) 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-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Analysis population: Analysis was performed on safety population evaluable for global health status. 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) | 139 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 134 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 137 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 61.19 | 20.64 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 60.10 | 20.02 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 109 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 123 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -1.45 | 21.03 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -1.22 | 22.42 | Not reported | Not reported | Not reported |
|---|
Day 1: Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Pd (Pomalidomide + Dexamethasone) | 69 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 102 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | -0.12 | 22.26 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -0.16 | 18.28 | 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) | 1.06 | 19.97 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.41 | 20.99 | 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) | -9.17 | 24.36 | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | -1.92 | 19.29 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.64
- value
- 61.19
- group Id
- OG001
- spread
- 20.02
- value
- 60.10
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 137
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 21.03
- value
- -1.45
- group Id
- OG001
- spread
- 22.42
- value
- -1.22
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 123
- units
- Participants
- title
- Day 1: Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 22.26
- value
- -0.12
- group Id
- OG001
- spread
- 18.28
- value
- -0.16
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 102
- units
- Participants
- title
- Day 1: Cycle 6
- categories
- measurements
- group Id
- OG000
- spread
- 19.97
- value
- 1.06
- group Id
- OG001
- spread
- 20.99
- value
- 0.41
- 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
- 24.36
- value
- -9.17
- group Id
- OG001
- spread
- 19.29
- value
- -1.92
- 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
- 139
- units
- Participants
- description
- EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
- 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 global health status. 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 Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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