Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants
Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17
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 (BL) (Day 1 of Cycle 1), Day 1 of Cycle 13 (Up to 1 year)
What was measured
EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
Analysis population: Participants from the Safety Population, defined as all participants who received at least 1 dose of any study drug, with data available for analysis.
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Global Health Status/QoL, Change from BL; Cycle 13
categories
measurements
group Id
OG000
spread
35.675
value
14.17
group Id
OG001
spread
20.640
value
17.97
title
Physical functioning, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
43.127
value
8.33
group Id
OG001
spread
35.441
value
6.52
title
Role functioning, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
27.837
value
11.34
group Id
OG001
spread
15.977
value
2.54
title
Emotional functioning, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
22.877
value
2.78
group Id
OG001
spread
14.058
value
-7.25
title
Cognitive functioning, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
39.921
value
9.03
group Id
OG001
spread
29.914
value
-11.59
title
Social functioning, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
35.307
value
-10.88
group Id
OG001
spread
30.473
value
-6.76
title
Fatigue, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
26.228
value
-4.86
group Id
OG001
spread
19.603
value
-4.35
title
Nausea/Vomiting, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
52.628
value
-13.89
group Id
OG001
spread
39.443
value
-10.87
title
Pain, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
37.644
value
-11.11
group Id
OG001
spread
40.147
value
-7.25
title
Dyspnea, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
46.104
value
-16.67
group Id
OG001
spread
35.441
value
-10.14
title
Insomnia, Change from BL at Cycle 13
categories
measurements
group Id
OG000
spread
42.822
value
-18.06
group Id
OG001
spread
24.529
value
-7.25
title
Appetite Loss, Change from BL at Cycle 13
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
23
units
Participants
description
EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
dispersion Type
Standard Deviation
groups
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Participants from the Safety Population, defined as all participants who received at least 1 dose of any study drug, with data available for analysis.
reporting Status
POSTED
time Frame
Baseline (BL) (Day 1 of Cycle 1), Day 1 of Cycle 13 (Up to 1 year)
title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants
Triangle