Trial Outcomes & Findings for Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study) (NCT NCT03188536)

NCT ID: NCT03188536

Last Updated: 2020-10-12

Results Overview

Sociodemographic variables included age(in years), sex(male or female), body mass index(BMI), residence(rural or urban), educational level(illiterate,no studies(can only read/write),primary studies,secondary studies,higher studies), work status(unemployed,active employment,temporarily/ permanently disabled, retired, other), cohabitation(lives-alone,with relatives,alone with help from a caregiver), need for financial assistance (yes/no), degree of dependence(independent,dependent:grade I-requires help to perform activities of daily living \[ADL\] at least once a day,grade II-needs help to perform ADLs 2 or 3 times a day or grade III-needs help to perform ADLs several times a day), healthy habits (high\[jogging;climbing;cycling;swimming;sports;intensive work;moving \>20 kg loads\], moderate\[walking;dancing;domestic chores;sports with children,walking house pets;general construction work;moving \<20 kg loads\] physical activity or inactive, smoking habit (yes/no), alcohol use (yes/no).

Recruitment status

COMPLETED

Target enrollment

282 participants

Primary outcome timeframe

Day 1

Results posted on

2020-10-12

Participant Flow

Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019.

Participants with a diagnosis of multiple myeloma with symptomatic relapse and/or refractory disease were observed to collect the retrospective data on Day 1.

Participant milestones

Participant milestones
Measure
Multiple Myeloma (MM) Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Overall Study
STARTED
282
Overall Study
COMPLETED
276
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Multiple Myeloma (MM) Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Overall Study
No relapse/refractoriness(last 6 months)
5
Overall Study
Not participated/met inclusion criteria
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Age, Continuous
67.4 years
STANDARD_DEVIATION 10.5 • n=276 Participants
Sex: Female, Male
Female
129 Participants
n=276 Participants
Sex: Female, Male
Male
147 Participants
n=276 Participants
Region of Enrollment
Spain
276 Participants
n=276 Participants
Body Mass Index (BMI)
27.5 Kg/m^2
STANDARD_DEVIATION 5.1 • n=276 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Percentages were rounded off.

Sociodemographic variables included age(in years), sex(male or female), body mass index(BMI), residence(rural or urban), educational level(illiterate,no studies(can only read/write),primary studies,secondary studies,higher studies), work status(unemployed,active employment,temporarily/ permanently disabled, retired, other), cohabitation(lives-alone,with relatives,alone with help from a caregiver), need for financial assistance (yes/no), degree of dependence(independent,dependent:grade I-requires help to perform activities of daily living \[ADL\] at least once a day,grade II-needs help to perform ADLs 2 or 3 times a day or grade III-needs help to perform ADLs several times a day), healthy habits (high\[jogging;climbing;cycling;swimming;sports;intensive work;moving \>20 kg loads\], moderate\[walking;dancing;domestic chores;sports with children,walking house pets;general construction work;moving \<20 kg loads\] physical activity or inactive, smoking habit (yes/no), alcohol use (yes/no).

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Age, Adults (27-90 years)
100 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Sex, Male
53.3 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Sex, Female
46.7 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
BMI, 15 to 52 kg/m^2
100 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Area of Residence, Rural
24.3 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Area of Residence, Urban
75.7 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Educational level, Illiteracy
0.7 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Educational level, No Studies (just read/write)
10.4 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Educational level, Primary studies
43.3 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Educational level, Secondary studies
34.1 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Educational level, Higher studies
11.5 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Work Status, Unemployed
5.5 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Work Status, Active
5.1 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Work Status, Temporary/permanent disability
20.0 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Work Status, Retired
65.1 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Work Status, Other
4.4 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Cohabitation status, Living Alone
12.4 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Cohabitation status, Living with Relatives
85.8 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Cohabitation, Living Alone with Assistance
1.8 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Need of Financial Support, No
93.8 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Level of Dependence, Independent
71.3 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Level of Dependence, Grade I
14.5 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Level of Dependence, Grade II
12.7 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Level of Dependence, Grade III
1.5 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Physical Activity, High
1.8 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Physical Activity, Moderate
45.8 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Physical Activity, Inactive
52.4 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Current smoking habit, Yes
3.6 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Current smoking habit, No
96.4 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Alcohol Use, Yes
6.5 percentage of participants
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Alcohol Use, No
93.5 percentage of participants

PRIMARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Participants are repeated for multiple CRAB signs and cytogenic abnormalities. Percentages were rounded off.

Clinical variables at Diagnosis included age,MM type(heavy/light chain/Bence-Jones protein), international staging system(ISS),disease stage(I:low risk,β2-Microglobulin\<3.5mg/L and albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-Microglobulin≥5.5mg/L),calcium,renal insufficiency,anemia or bone lesions(CRAB) signs(serum calcium\>0.25mmol/L upper limit of normal,renal failure-creatinine clearance\<40mL/min/serum creatinine\>117μmol/L, anemia:reduction of hemoglobin(Hb)\>2g/dL below lower limit of normal or Hb\<10g/dL,bone lesions 1/more osteolytic lesion,cytogenetic abnormalities(t\[4;14\],t\[11;14\],t\[14;16\],t\[14;20\],t\[6;14\],trisomies,d\[17p\],g\[1q\]/others), risk according to cytogenetic profile(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), eastern cooperative oncology group(ECOG) status (0:fully active,1:restricted physical activity,2:ambulatory,unable to carry out any work,3:capable of limited selfcare,4:completely disabled,5:dead).

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Age, Adults (27-90 years)
100 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Heavy chain, IgA
24.1 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Heavy chain, IgD
1.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Heavy chain, IgG
56.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Heavy chain, IgM
0.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Heavy chain, No Heavy Chain
16.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Light Chain, No Light Chain
3.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Light Chain, Kappa
59.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Light Chain, Lambda
37.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
MM Type, Bence Jones Protein, Yes
53.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ISS Disease Stage I
28.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ISS Disease Stage II
28.1 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ISS Disease Stage III
43.1 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
CRAB Signs, None
12.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
CRAB Signs, Some, Increase in blood calcium levels
12.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
CRAB Signs, Some, Renal failure
18.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
CRAB Signs, Some, Anemia
52.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
CRAB Signs, Some, Bone lesions
76.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, t (4;14)
11.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, t (11;14)
14.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, t (14;16)
1.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, Trisomies
3.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, d (17p)
17.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, g (1q)
21.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Cytogenetic abnormalities, Other
66.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Risk, High
19.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Risk, Standard
12.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Risk, Intermediate
23.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Risk, Other
44.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ECOG Status, 0
29.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ECOG Status, 1
41.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ECOG Status, 2
22.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
ECOG Status, 3
6.2 percentage of participants

PRIMARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Participants are repeated across multiple categories. Percentages were rounded off.

Clinical variables include date of latest symptomatic relapse and/or refractory episode, ISS disease stage, CRAB signs, other clinical variables (plasmacytomas: medullary or extramedullary, diffuse osteopenia, fractures, neurological symptoms, infections, concomitant diseases like diabetes, neuropathy, chronic obstructive pulmonary disease (COPD), cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders, cytogenetic abnormalities, risk according to cytogenetic profile at relapse(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), treatment started after latest symptomatic relapse and/or refractory episode.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
DoublePI Therapy+Steroids/Alkylating Agent,>=4Line
6.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Relapse Within 6 Months of Last Relapse
61.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I
37.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II
35.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III
27.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None
25.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some-Increase in blood calcium levels
9.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some-Renal Failure
20.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some-Anemia
43.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some-Bone lesions
65.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, t(4;14)
11.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, t(11;14)
8.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, t(14;16)
5.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, Trisomies
4.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, d (17p)
19.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, g (1q)
27.96 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Cytogenetic Abnormalities, other
64.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Risk, High
38.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard
12.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Risk, Intermediate
49.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Diffuse osteopathy
15.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Fractures
15.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Neurological symptoms
8.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Infections
15.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Diabetes
24.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Neuropathy
20.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Nephropathy
15.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidity, COPD
11.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Cardiovascular disease
48.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Liver failure
1.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities,Psychiatric or Neurological Disorder
14.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Other secondary disorders
45.7 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma
15.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma
15.6 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Anti-CD38 mAb Monotherapy, Second Line
0.9 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Anti-CD38 mAb Monotherapy, Third Line
13.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Anti-CD38 mAb Monotherapy, Fourth Line or Later
20.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Double PI Therapy+Steroids/Alkylating Agent,2 Line
9.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Double PI therapy+Steroids/Alkylating Agent,3 Line
10.3 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous transplant, Second Line
2.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous transplant, Third Line
7.0 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous transplant, Fourth Line or Later
1.2 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Allogeneic transplant, Second Line
0.8 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Allogeneic transplant, Third Line
1.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Allogeneic transplant, Fourth Line or Later
2.4 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous or Allogeneic Transplant, Second Line
2.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous or Allogeneic Transplant, Third Line
8.5 percentage of participants
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Autologous or Allogeneic Transplant, >=4 Lines
3.5 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Percentages were rounded off.

Clinical and Sociodemographic variables categorized by treatment selection(immunomodulators\[IMiDs\],proteasome inhibitor\[PI\]+IMiDs,PI,monoclonal antibodies\[mAb\]): Age,sex(male/female),prior treatment lines(0,1,2,3 or more),prior relapses(0,1,2,3 or more),ISS disease stage(I:low risk,β2-Microglobulin\<3.5mg/L,albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-Microglobulin≥5.5mg/L),CRAB signs(serum calcium\>0.25mmol/L upper limit of normal,renal failure-creatinine clearance\<40mL/min/serum creatinine\>117μmol/L,anemia:reduction of hemoglobin(Hb)\>2g/dL below lower limit of normal or Hb\<10g/dL,bone lesions 1/more osteolytic lesion),risk according to cytogenetic profile(standard:trisomies,t\[11;14\];t\[6;14\];high:d\[17p\],t\[14;16\],t\[14;20\],other),other clinical variables:medullary/extramedullary plasmacytomas,osteopenia,fractures,neurological symptoms,infections,concomitant diseases:diabetes, neuropathy, COPD, cardiovascular disease, liver failure, psychiatric, neurological disorders.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Age, 38-85 years, IMiDs
100 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Age, 43-76 years, PI + IMiDs
100 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Age, 47-84 years, PI
100 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Age, 39-80 years, mAb
100 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Age, 53-90 years, Other
100 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Male, IMiDs
49.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Female, IMiDs
50.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Male, PI + IMiDs
61.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Female, PI + IMiDs
38.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Male, PI
47.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Female, PI
52.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Male, mAb
55.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Female, mAb
44.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Male, Other
57.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Sex, Female, Other
42.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 1, IMiDs
50.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 2, IMiDs
28.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 3 or more, IMiDs
21.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 1, PI + IMiDs
63.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 2, PI + IMiDs
16.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 3 or more, PI + IMiDs
20.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 1, PI
44.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 2, PI
35.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 3 or more, PI
20.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 1, mAb
26.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 2, mAb
29.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 3 or more, mAb
44.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 1, Other
11.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 2, Other
26.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Prior lines of treatment, 3 or more, Other
61.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 0, IMiDs
43.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 1, IMiDs
31.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 2, IMiDs
12.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 3 and more, IMiDs
12.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 0, PI + IMiDs
49.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 1, PI + IMiDs
36.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 2, PI + IMiDs
2.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 3 or more, PI + IMiDs
12.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 0, PI
47.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 1, PI
32.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 2, PI
2.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 3 or more, PI
17.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 0, mAb
27.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 1, mAb
26.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 2, mAb
18.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 3 or more, mAb
27.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 0, Other
11.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 1, Other
26.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 2, Other
23.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Number of prior relapses, 3 or more, Other
38.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I, IMiDs
38.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II, IMiDs
38.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III, IMiDs
23.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I, PI + IMiDs
51.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II, PI + IMiDs
28.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III, PI + IMiDs
20.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I, PI
20.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II, PI
54.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III, PI
25.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I, mAb
40.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II, mAb
32.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III, mAb
28.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage I, Other
23.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage II, Other
23.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
ISS Disease Stage III, Other
52.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None, IMiDs
29.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some, IMiDs
70.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None, PI + IMiDs
14.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some, PI + IMiDs
85.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None, PI
20.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some, PI
79.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None, mAb
31.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some, mAb
68.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, None, Other
23.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
CRAB Signs, Some, Other
76.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, None, IMiDs
41.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Some, IMiDs
58.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, None, PI + IMiDs
49.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Some, PI + IMiDs
51.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, None, PI
35.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Some, PI
64.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, None, mAb
32.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Some, mAb
67.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, None, Other
23.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Comorbidities, Some, Other
76.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, High, IMiDs
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard, IMiDs
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, High, PI + IMiDs
41.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard, PI + IMiDs
58.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, High, PI
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard, PI
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, High, mAb
60.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard, mAb
40.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, High, Other
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Risk, Standard, Other
50.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, Yes, IMiDs
15.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, No, IMiDs
84.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, Yes, PI + IMiDs
25.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, No, PI + IMiDs
75.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, Yes, PI
14.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, No, PI
85.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, Yes, mAb
8.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, No, mAb
91.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, Yes, Other
16.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Medullary Plasmacytoma, No, Other
84.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, Yes, IMiDs
12.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, No, IMiDs
87.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, Yes, PI + IMiDs
33.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, No, PI + IMiDs
66.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, Yes, PI
11.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, No, PI
88.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, Yes, mAb
6.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, No, mAb
93.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, Yes, Other
24.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Extramedullary Plasmacytoma, No, Other
76.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, Yes, IMiDs
23.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, No, IMiDs
76.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, Yes, PI + IMiDs
6.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, No, PI + IMiDs
93.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, Yes, PI
8.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, No, PI
91.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, Yes, mAb
13.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, No, mAb
86.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, Yes, Other
23.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Osteopenia, No, Other
76.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, Yes, IMiDs
15.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, No, IMiDs
84.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, Yes, PI + IMiDs
18.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, No, PI + IMiDs
81.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, Yes, PI
11.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, No, PI
88.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, Yes, mAb
14.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, No, mAb
85.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, Yes, Other
15.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Fractures, No, Other
84.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, Yes, IMiDs
10.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, No, IMiDs
89.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, Yes, PI + IMiDs
10.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, No, PI + IMiDs
89.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, Yes, PI
5.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, No, PI
94.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, Yes, mAb
1.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, No, mAb
98.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, Yes, Other
11.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Neurological Symptoms, No, Other
88.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, Yes, IMiDs
5.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, No, IMiDs
94.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, Yes, PI + IMiDs
8.2 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, No, PI + IMiDs
91.8 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, Yes, PI
5.9 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, No, PI
94.1 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, Yes, mAb
0.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, No, mAb
100.0 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, Yes, Other
7.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
MM Related Neurological Symptoms, No, Other
92.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, Yes, IMiDs
14.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, No, IMiDs
85.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, Yes, PI + IMiDs
20.4 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, No, PI + IMiDs
79.6 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, Yes, PI
14.7 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, No, PI
85.3 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, Yes, mAb
11.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, No, mAb
88.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, Yes, Other
11.5 percentage of participants
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Infections, No, Other
88.5 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.

The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale with a recall period of the previous week. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=273 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
53.5 score on a scale
Standard Deviation 23.9

SECONDARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.

The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=273 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Future perspective
58.4 score on scale
Standard Deviation 27.7
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Body image
72.9 score on scale
Standard Deviation 34.4
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Symptoms of the disease
30.7 score on scale
Standard Deviation 23.2
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Adverse effects of the treatment
25.4 score on scale
Standard Deviation 17.2

SECONDARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category.

The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. Spanish Translated Version of EORTC Multiple Myeloma Module included 4 factors, each factor corresponds to questions related to the particular component of the scale. Factor I indicate symptoms. Factor II indicates future perspectives. Factor III indicate adverse effects of the treatment. Factor IV indicates adverse effects of the treatment and body image. Each of these factors were used for the clinical validity of the scale.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Future perspective, Factors I-II
60.3 score on a scale
Standard Deviation 28.2
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Future perspective, Factors III
53.9 score on a scale
Standard Deviation 24.9
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Body image, Factors I-II
73.9 score on a scale
Standard Deviation 35.5
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Body image, Factors III
73.0 score on a scale
Standard Deviation 32.7
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Symptoms of the disease, Factors I-II
31.9 score on a scale
Standard Deviation 23.6
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Symptoms of the disease, Factors III
27.3 score on a scale
Standard Deviation 22.1
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Adverse effects of the treatment, Factors I-II
24.3 score on a scale
Standard Deviation 16.9
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Adverse effects of the treatment, Factors III
29.0 score on a scale
Standard Deviation 17.5

SECONDARY outcome

Timeframe: Day 1

Population: All participants eligible for analyses were included.

Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.

Outcome measures

Outcome measures
Measure
Multiple Myeloma (MM) Participants
n=276 Participants
Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Percentage of Participants With Health Care Resource Utilization (HU)
Consultation with the primary care physician
21.7 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Admitted at some healthcare service
56.2 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Admitted to Hospital
59.4 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Used ambulance to attend to the hospital
7.0 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Used their own transport
67.8 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Consultation with the oncologist
2.5 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Consultation with the psychologist
3.6 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Attended psychologist
60 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Attended hematologist
89.1 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Required some test
82.2 percentage of participants
Percentage of Participants With Health Care Resource Utilization (HU)
Had undergone X-ray test
43.2 percentage of participants

Adverse Events

Multiple Myeloma (MM) Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Results disclosure agreements

  • Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
  • Publication restrictions are in place

Restriction type: OTHER