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Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)

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ClinicalTrials.gov Identifier: NCT03188536
Recruitment Status : Completed
First Posted : June 15, 2017
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Multiple Myeloma
Intervention Other: No Intervention
Enrollment 282
Recruitment Details Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019.
Pre-assignment Details Participants with a diagnosis of multiple myeloma with symptomatic relapse and/or refractory disease were observed to collect the retrospective data on Day 1.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 282
Completed 276
Not Completed 6
Reason Not Completed
No relapse/refractoriness(last 6 months)             5
Not participated/met inclusion criteria             1
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description 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 Number of Baseline Participants 276
Hide Baseline Analysis Population Description
All participants eligible for analyses were included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 276 participants
67.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants
Female
129
  46.7%
Male
147
  53.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Spain Number Analyzed 276 participants
276
 100.0%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 276 participants
27.5  (5.1)
[1]
Measure Description: BMI=Weight (kg)/Height(m)^2.
1.Primary Outcome
Title Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Hide Description 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).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of participants
Age, Adults (27-90 years) Number Analyzed 276 participants
100
Sex, Male Number Analyzed 276 participants
53.3
Sex, Female Number Analyzed 276 participants
46.7
BMI, 15 to 52 kg/m^2 Number Analyzed 276 participants
100
Area of Residence, Rural Number Analyzed 276 participants
24.3
Area of Residence, Urban Number Analyzed 276 participants
75.7
Educational level, Illiteracy Number Analyzed 270 participants
0.7
Educational level, No Studies (just read/write) Number Analyzed 270 participants
10.4
Educational level, Primary studies Number Analyzed 270 participants
43.3
Educational level, Secondary studies Number Analyzed 270 participants
34.1
Educational level, Higher studies Number Analyzed 270 participants
11.5
Work Status, Unemployed Number Analyzed 275 participants
5.5
Work Status, Active Number Analyzed 275 participants
5.1
Work Status, Temporary/permanent disability Number Analyzed 275 participants
20.0
Work Status, Retired Number Analyzed 275 participants
65.1
Work Status, Other Number Analyzed 275 participants
4.4
Cohabitation status, Living Alone Number Analyzed 274 participants
12.4
Cohabitation status, Living with Relatives Number Analyzed 274 participants
85.8
Cohabitation, Living Alone with Assistance Number Analyzed 274 participants
1.8
Need of Financial Support, No Number Analyzed 274 participants
93.8
Level of Dependence, Independent Number Analyzed 275 participants
71.3
Level of Dependence, Grade I Number Analyzed 275 participants
14.5
Level of Dependence, Grade II Number Analyzed 275 participants
12.7
Level of Dependence, Grade III Number Analyzed 275 participants
1.5
Physical Activity, High Number Analyzed 275 participants
1.8
Physical Activity, Moderate Number Analyzed 275 participants
45.8
Physical Activity, Inactive Number Analyzed 275 participants
52.4
Current smoking habit, Yes Number Analyzed 276 participants
3.6
Current smoking habit, No Number Analyzed 276 participants
96.4
Alcohol Use, Yes Number Analyzed 276 participants
6.5
Alcohol Use, No Number Analyzed 276 participants
93.5
2.Primary Outcome
Title Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Hide Description 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).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of participants
Age, Adults (27-90 years) Number Analyzed 276 participants
100
MM Type, Heavy chain, IgA Number Analyzed 266 participants
24.1
MM Type, Heavy chain, IgD Number Analyzed 266 participants
1.9
MM Type, Heavy chain, IgG Number Analyzed 266 participants
56.8
MM Type, Heavy chain, IgM Number Analyzed 266 participants
0.8
MM Type, Heavy chain, No Heavy Chain Number Analyzed 266 participants
16.5
MM Type, Light Chain, No Light Chain Number Analyzed 276 participants
3.3
MM Type, Light Chain, Kappa Number Analyzed 276 participants
59.8
MM Type, Light Chain, Lambda Number Analyzed 276 participants
37.0
MM Type, Bence Jones Protein, Yes Number Analyzed 235 participants
53.6
ISS Disease Stage I Number Analyzed 267 participants
28.8
ISS Disease Stage II Number Analyzed 267 participants
28.1
ISS Disease Stage III Number Analyzed 267 participants
43.1
CRAB Signs, None Number Analyzed 276 participants
12.7
CRAB Signs, Some, Increase in blood calcium levels Number Analyzed 241 participants
12.0
CRAB Signs, Some, Renal failure Number Analyzed 241 participants
18.7
CRAB Signs, Some, Anemia Number Analyzed 241 participants
52.7
CRAB Signs, Some, Bone lesions Number Analyzed 241 participants
76.3
Cytogenetic abnormalities, t (4;14) Number Analyzed 106 participants
11.3
Cytogenetic abnormalities, t (11;14) Number Analyzed 106 participants
14.2
Cytogenetic abnormalities, t (14;16) Number Analyzed 106 participants
1.9
Cytogenetic abnormalities, Trisomies Number Analyzed 106 participants
3.8
Cytogenetic abnormalities, d (17p) Number Analyzed 106 participants
17.9
Cytogenetic abnormalities, g (1q) Number Analyzed 106 participants
21.7
Cytogenetic abnormalities, Other Number Analyzed 106 participants
66.0
Risk, High Number Analyzed 106 participants
19.8
Risk, Standard Number Analyzed 106 participants
12.3
Risk, Intermediate Number Analyzed 106 participants
23.6
Risk, Other Number Analyzed 106 participants
44.3
ECOG Status, 0 Number Analyzed 195 participants
29.7
ECOG Status, 1 Number Analyzed 195 participants
41.5
ECOG Status, 2 Number Analyzed 195 participants
22.6
ECOG Status, 3 Number Analyzed 195 participants
6.2
3.Primary Outcome
Title Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of participants
Relapse Within 6 Months of Last Relapse Number Analyzed 276 participants
61.6
ISS Disease Stage I Number Analyzed 211 participants
37.4
ISS Disease Stage II Number Analyzed 211 participants
35.5
ISS Disease Stage III Number Analyzed 211 participants
27.0
CRAB Signs, None Number Analyzed 276 participants
25.7
CRAB Signs, Some-Increase in blood calcium levels Number Analyzed 205 participants
9.3
CRAB Signs, Some-Renal Failure Number Analyzed 205 participants
20.5
CRAB Signs, Some-Anemia Number Analyzed 205 participants
43.9
CRAB Signs, Some-Bone lesions Number Analyzed 205 participants
65.9
Cytogenetic Abnormalities, t(4;14) Number Analyzed 87 participants
11.5
Cytogenetic Abnormalities, t(11;14) Number Analyzed 87 participants
8.0
Cytogenetic Abnormalities, t(14;16) Number Analyzed 87 participants
5.7
Cytogenetic Abnormalities, Trisomies Number Analyzed 87 participants
4.6
Cytogenetic Abnormalities, d (17p) Number Analyzed 87 participants
19.5
Cytogenetic Abnormalities, g (1q) Number Analyzed 87 participants
27.96
Cytogenetic Abnormalities, other Number Analyzed 87 participants
64.4
Risk, High Number Analyzed 49 participants
38.8
Risk, Standard Number Analyzed 49 participants
12.2
Risk, Intermediate Number Analyzed 49 participants
49.0
Diffuse osteopathy Number Analyzed 272 participants
15.4
Fractures Number Analyzed 276 participants
15.2
Neurological symptoms Number Analyzed 276 participants
8.0
Infections Number Analyzed 276 participants
15.2
Comorbidities, Diabetes Number Analyzed 175 participants
24.6
Comorbidities, Neuropathy Number Analyzed 175 participants
20.6
Comorbidities, Nephropathy Number Analyzed 175 participants
15.4
Comorbidity, COPD Number Analyzed 175 participants
11.4
Comorbidities, Cardiovascular disease Number Analyzed 175 participants
48.6
Comorbidities, Liver failure Number Analyzed 175 participants
1.7
Comorbidities,Psychiatric or Neurological Disorder Number Analyzed 175 participants
14.3
Comorbidities, Other secondary disorders Number Analyzed 175 participants
45.7
Medullary Plasmacytoma Number Analyzed 276 participants
15.3
Extramedullary Plasmacytoma Number Analyzed 276 participants
15.6
Anti-CD38 mAb Monotherapy, Second Line Number Analyzed 112 participants
0.9
Anti-CD38 mAb Monotherapy, Third Line Number Analyzed 68 participants
13.2
Anti-CD38 mAb Monotherapy, Fourth Line or Later Number Analyzed 79 participants
20.3
Double PI Therapy+Steroids/Alkylating Agent,2 Line Number Analyzed 112 participants
9.8
Double PI therapy+Steroids/Alkylating Agent,3 Line Number Analyzed 68 participants
10.3
DoublePI Therapy+Steroids/Alkylating Agent,>=4Line Number Analyzed 79 participants
6.3
Autologous transplant, Second Line Number Analyzed 119 participants
2.5
Autologous transplant, Third Line Number Analyzed 71 participants
7.0
Autologous transplant, Fourth Line or Later Number Analyzed 85 participants
1.2
Allogeneic transplant, Second Line Number Analyzed 119 participants
0.8
Allogeneic transplant, Third Line Number Analyzed 71 participants
1.4
Allogeneic transplant, Fourth Line or Later Number Analyzed 85 participants
2.4
Autologous or Allogeneic Transplant, Second Line Number Analyzed 119 participants
2.5
Autologous or Allogeneic Transplant, Third Line Number Analyzed 71 participants
8.5
Autologous or Allogeneic Transplant, >=4 Lines Number Analyzed 85 participants
3.5
4.Secondary Outcome
Title Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of participants
Age, 38-85 years, IMiDs Number Analyzed 89 participants
100
Age, 43-76 years, PI + IMiDs Number Analyzed 49 participants
100
Age, 47-84 years, PI Number Analyzed 34 participants
100
Age, 39-80 years, mAb Number Analyzed 61 participants
100
Age, 53-90 years, Other Number Analyzed 26 participants
100
Sex, Male, IMiDs Number Analyzed 89 participants
49.4
Sex, Female, IMiDs Number Analyzed 89 participants
50.6
Sex, Male, PI + IMiDs Number Analyzed 49 participants
61.2
Sex, Female, PI + IMiDs Number Analyzed 49 participants
38.8
Sex, Male, PI Number Analyzed 34 participants
47.1
Sex, Female, PI Number Analyzed 34 participants
52.9
Sex, Male, mAb Number Analyzed 61 participants
55.7
Sex, Female, mAb Number Analyzed 61 participants
44.3
Sex, Male, Other Number Analyzed 26 participants
57.7
Sex, Female, Other Number Analyzed 26 participants
42.3
Prior lines of treatment, 1, IMiDs Number Analyzed 89 participants
50.6
Prior lines of treatment, 2, IMiDs Number Analyzed 89 participants
28.1
Prior lines of treatment, 3 or more, IMiDs Number Analyzed 89 participants
21.3
Prior lines of treatment, 1, PI + IMiDs Number Analyzed 49 participants
63.3
Prior lines of treatment, 2, PI + IMiDs Number Analyzed 49 participants
16.3
Prior lines of treatment, 3 or more, PI + IMiDs Number Analyzed 49 participants
20.4
Prior lines of treatment, 1, PI Number Analyzed 34 participants
44.1
Prior lines of treatment, 2, PI Number Analyzed 34 participants
35.3
Prior lines of treatment, 3 or more, PI Number Analyzed 34 participants
20.6
Prior lines of treatment, 1, mAb Number Analyzed 61 participants
26.2
Prior lines of treatment, 2, mAb Number Analyzed 61 participants
29.5
Prior lines of treatment, 3 or more, mAb Number Analyzed 61 participants
44.3
Prior lines of treatment, 1, Other Number Analyzed 26 participants
11.5
Prior lines of treatment, 2, Other Number Analyzed 26 participants
26.9
Prior lines of treatment, 3 or more, Other Number Analyzed 26 participants
61.5
Number of prior relapses, 0, IMiDs Number Analyzed 89 participants
43.8
Number of prior relapses, 1, IMiDs Number Analyzed 89 participants
31.5
Number of prior relapses, 2, IMiDs Number Analyzed 89 participants
12.4
Number of prior relapses, 3 and more, IMiDs Number Analyzed 89 participants
12.4
Number of prior relapses, 0, PI + IMiDs Number Analyzed 49 participants
49.0
Number of prior relapses, 1, PI + IMiDs Number Analyzed 49 participants
36.7
Number of prior relapses, 2, PI + IMiDs Number Analyzed 49 participants
2.0
Number of prior relapses, 3 or more, PI + IMiDs Number Analyzed 49 participants
12.2
Number of prior relapses, 0, PI Number Analyzed 34 participants
47.1
Number of prior relapses, 1, PI Number Analyzed 34 participants
32.4
Number of prior relapses, 2, PI Number Analyzed 34 participants
2.9
Number of prior relapses, 3 or more, PI Number Analyzed 34 participants
17.6
Number of prior relapses, 0, mAb Number Analyzed 61 participants
27.9
Number of prior relapses, 1, mAb Number Analyzed 61 participants
26.2
Number of prior relapses, 2, mAb Number Analyzed 61 participants
18.0
Number of prior relapses, 3 or more, mAb Number Analyzed 61 participants
27.9
Number of prior relapses, 0, Other Number Analyzed 26 participants
11.5
Number of prior relapses, 1, Other Number Analyzed 26 participants
26.9
Number of prior relapses, 2, Other Number Analyzed 26 participants
23.1
Number of prior relapses, 3 or more, Other Number Analyzed 26 participants
38.5
ISS Disease Stage I, IMiDs Number Analyzed 65 participants
38.5
ISS Disease Stage II, IMiDs Number Analyzed 65 participants
38.5
ISS Disease Stage III, IMiDs Number Analyzed 65 participants
23.1
ISS Disease Stage I, PI + IMiDs Number Analyzed 39 participants
51.3
ISS Disease Stage II, PI + IMiDs Number Analyzed 39 participants
28.2
ISS Disease Stage III, PI + IMiDs Number Analyzed 39 participants
20.5
ISS Disease Stage I, PI Number Analyzed 24 participants
20.8
ISS Disease Stage II, PI Number Analyzed 24 participants
54.2
ISS Disease Stage III, PI Number Analyzed 24 participants
25.0
ISS Disease Stage I, mAb Number Analyzed 50 participants
40.0
ISS Disease Stage II, mAb Number Analyzed 50 participants
32.0
ISS Disease Stage III, mAb Number Analyzed 50 participants
28.0
ISS Disease Stage I, Other Number Analyzed 21 participants
23.8
ISS Disease Stage II, Other Number Analyzed 21 participants
23.8
ISS Disease Stage III, Other Number Analyzed 21 participants
52.4
CRAB Signs, None, IMiDs Number Analyzed 89 participants
29.2
CRAB Signs, Some, IMiDs Number Analyzed 89 participants
70.8
CRAB Signs, None, PI + IMiDs Number Analyzed 49 participants
14.3
CRAB Signs, Some, PI + IMiDs Number Analyzed 49 participants
85.7
CRAB Signs, None, PI Number Analyzed 34 participants
20.6
CRAB Signs, Some, PI Number Analyzed 34 participants
79.4
CRAB Signs, None, mAb Number Analyzed 61 participants
31.1
CRAB Signs, Some, mAb Number Analyzed 61 participants
68.9
CRAB Signs, None, Other Number Analyzed 26 participants
23.1
CRAB Signs, Some, Other Number Analyzed 26 participants
76.9
Comorbidities, None, IMiDs Number Analyzed 89 participants
41.6
Comorbidities, Some, IMiDs Number Analyzed 89 participants
58.4
Comorbidities, None, PI + IMiDs Number Analyzed 49 participants
49.0
Comorbidities, Some, PI + IMiDs Number Analyzed 49 participants
51.0
Comorbidities, None, PI Number Analyzed 34 participants
35.3
Comorbidities, Some, PI Number Analyzed 34 participants
64.7
Comorbidities, None, mAb Number Analyzed 61 participants
32.8
Comorbidities, Some, mAb Number Analyzed 61 participants
67.2
Comorbidities, None, Other Number Analyzed 26 participants
23.1
Comorbidities, Some, Other Number Analyzed 26 participants
76.9
Risk, High, IMiDs Number Analyzed 10 participants
50.0
Risk, Standard, IMiDs Number Analyzed 10 participants
50.0
Risk, High, PI + IMiDs Number Analyzed 12 participants
41.7
Risk, Standard, PI + IMiDs Number Analyzed 12 participants
58.3
Risk, High, PI Number Analyzed 4 participants
50.0
Risk, Standard, PI Number Analyzed 4 participants
50.0
Risk, High, mAb Number Analyzed 15 participants
60.0
Risk, Standard, mAb Number Analyzed 15 participants
40.0
Risk, High, Other Number Analyzed 4 participants
50.0
Risk, Standard, Other Number Analyzed 4 participants
50.0
Medullary Plasmacytoma, Yes, IMiDs Number Analyzed 84 participants
15.5
Medullary Plasmacytoma, No, IMiDs Number Analyzed 84 participants
84.5
Medullary Plasmacytoma, Yes, PI + IMiDs Number Analyzed 44 participants
25.0
Medullary Plasmacytoma, No, PI + IMiDs Number Analyzed 44 participants
75.0
Medullary Plasmacytoma, Yes, PI Number Analyzed 34 participants
14.7
Medullary Plasmacytoma, No, PI Number Analyzed 34 participants
85.3
Medullary Plasmacytoma, Yes, mAb Number Analyzed 58 participants
8.6
Medullary Plasmacytoma, No, mAb Number Analyzed 58 participants
91.4
Medullary Plasmacytoma, Yes, Other Number Analyzed 25 participants
16.0
Medullary Plasmacytoma, No, Other Number Analyzed 25 participants
84.0
Extramedullary Plasmacytoma, Yes, IMiDs Number Analyzed 86 participants
12.8
Extramedullary Plasmacytoma, No, IMiDs Number Analyzed 86 participants
87.2
Extramedullary Plasmacytoma, Yes, PI + IMiDs Number Analyzed 48 participants
33.3
Extramedullary Plasmacytoma, No, PI + IMiDs Number Analyzed 48 participants
66.7
Extramedullary Plasmacytoma, Yes, PI Number Analyzed 34 participants
11.8
Extramedullary Plasmacytoma, No, PI Number Analyzed 34 participants
88.2
Extramedullary Plasmacytoma, Yes, mAb Number Analyzed 60 participants
6.7
Extramedullary Plasmacytoma, No, mAb Number Analyzed 60 participants
93.3
Extramedullary Plasmacytoma, Yes, Other Number Analyzed 25 participants
24.0
Extramedullary Plasmacytoma, No, Other Number Analyzed 25 participants
76.0
Osteopenia, Yes, IMiDs Number Analyzed 88 participants
23.9
Osteopenia, No, IMiDs Number Analyzed 88 participants
76.1
Osteopenia, Yes, PI + IMiDs Number Analyzed 48 participants
6.3
Osteopenia, No, PI + IMiDs Number Analyzed 48 participants
93.8
Osteopenia, Yes, PI Number Analyzed 34 participants
8.8
Osteopenia, No, PI Number Analyzed 34 participants
91.2
Osteopenia, Yes, mAb Number Analyzed 60 participants
13.3
Osteopenia, No, mAb Number Analyzed 60 participants
86.7
Osteopenia, Yes, Other Number Analyzed 26 participants
23.1
Osteopenia, No, Other Number Analyzed 26 participants
76.9
Fractures, Yes, IMiDs Number Analyzed 89 participants
15.7
Fractures, No, IMiDs Number Analyzed 89 participants
84.3
Fractures, Yes, PI + IMiDs Number Analyzed 49 participants
18.4
Fractures, No, PI + IMiDs Number Analyzed 49 participants
81.6
Fractures, Yes, PI Number Analyzed 34 participants
11.8
Fractures, No, PI Number Analyzed 34 participants
88.2
Fractures, Yes, mAb Number Analyzed 61 participants
14.8
Fractures, No, mAb Number Analyzed 61 participants
85.2
Fractures, Yes, Other Number Analyzed 26 participants
15.4
Fractures, No, Other Number Analyzed 26 participants
84.6
Neurological Symptoms, Yes, IMiDs Number Analyzed 89 participants
10.1
Neurological Symptoms, No, IMiDs Number Analyzed 89 participants
89.9
Neurological Symptoms, Yes, PI + IMiDs Number Analyzed 49 participants
10.2
Neurological Symptoms, No, PI + IMiDs Number Analyzed 49 participants
89.8
Neurological Symptoms, Yes, PI Number Analyzed 34 participants
5.9
Neurological Symptoms, No, PI Number Analyzed 34 participants
94.1
Neurological Symptoms, Yes, mAb Number Analyzed 61 participants
1.6
Neurological Symptoms, No, mAb Number Analyzed 61 participants
98.4
Neurological Symptoms, Yes, Other Number Analyzed 26 participants
11.5
Neurological Symptoms, No, Other Number Analyzed 26 participants
88.5
MM Related Neurological Symptoms, Yes, IMiDs Number Analyzed 89 participants
5.6
MM Related Neurological Symptoms, No, IMiDs Number Analyzed 89 participants
94.4
MM Related Neurological Symptoms, Yes, PI + IMiDs Number Analyzed 49 participants
8.2
MM Related Neurological Symptoms, No, PI + IMiDs Number Analyzed 49 participants
91.8
MM Related Neurological Symptoms, Yes, PI Number Analyzed 34 participants
5.9
MM Related Neurological Symptoms, No, PI Number Analyzed 34 participants
94.1
MM Related Neurological Symptoms, Yes, mAb Number Analyzed 61 participants
0.0
MM Related Neurological Symptoms, No, mAb Number Analyzed 61 participants
100.0
MM Related Neurological Symptoms, Yes, Other Number Analyzed 26 participants
7.7
MM Related Neurological Symptoms, No, Other Number Analyzed 26 participants
92.3
Infections, Yes, IMiDs Number Analyzed 89 participants
14.6
Infections, No, IMiDs Number Analyzed 89 participants
85.4
Infections, Yes, PI + IMiDs Number Analyzed 49 participants
20.4
Infections, No, PI + IMiDs Number Analyzed 49 participants
79.6
Infections, Yes, PI Number Analyzed 34 participants
14.7
Infections, No, PI Number Analyzed 34 participants
85.3
Infections, Yes, mAb Number Analyzed 61 participants
11.5
Infections, No, mAb Number Analyzed 61 participants
88.5
Infections, Yes, Other Number Analyzed 26 participants
11.5
Infections, No, Other Number Analyzed 26 participants
88.5
5.Secondary Outcome
Title Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
Overall Number of Units Analyzed
Type of Units Analyzed: Variables
0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 273
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.5  (23.9)
7.Secondary Outcome
Title HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 273
Mean (Standard Deviation)
Unit of Measure: score on scale
Future perspective 58.4  (27.7)
Body image 72.9  (34.4)
Symptoms of the disease 30.7  (23.2)
Adverse effects of the treatment 25.4  (17.2)
8.Secondary Outcome
Title HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: score on a scale
Future perspective, Factors I-II Number Analyzed 142 participants
60.3  (28.2)
Future perspective, Factors III Number Analyzed 53 participants
53.9  (24.9)
Body image, Factors I-II Number Analyzed 142 participants
73.9  (35.5)
Body image, Factors III Number Analyzed 53 participants
73.0  (32.7)
Symptoms of the disease, Factors I-II Number Analyzed 142 participants
31.9  (23.6)
Symptoms of the disease, Factors III Number Analyzed 53 participants
27.3  (22.1)
Adverse effects of the treatment, Factors I-II Number Analyzed 142 participants
24.3  (16.9)
Adverse effects of the treatment, Factors III Number Analyzed 53 participants
29.0  (17.5)
9.Secondary Outcome
Title Percentage of Participants With Health Care Resource Utilization (HU)
Hide Description Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants eligible for analyses were included.
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description:
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 Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of participants
Admitted at some healthcare service 56.2
Admitted to Hospital 59.4
Used ambulance to attend to the hospital 7.0
Used their own transport 67.8
Consultation with the primary care physician 21.7
Consultation with the oncologist 2.5
Consultation with the psychologist 3.6
Attended psychologist 60
Attended hematologist 89.1
Required some test 82.2
Had undergone X-ray test 43.2
Time Frame From enrollment on 26 July 2017 to last date of assessment 30 January 2019 (Up to 1.5 years)
Adverse Event Reporting Description Data of adverse events or adverse drug reactions were not collected as part of the study database.
 
Arm/Group Title Multiple Myeloma (MM) Participants
Hide Arm/Group Description 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.
All-Cause Mortality
Multiple Myeloma (MM) Participants
Affected / at Risk (%)
Total   0/276 (0.00%) 
Hide Serious Adverse Events
Multiple Myeloma (MM) Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multiple Myeloma (MM) Participants
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03188536    
Other Study ID Numbers: RRMM-5012
TAK-MMR-2017-01 ( Registry Identifier: Spanish health authority )
First Submitted: June 12, 2017
First Posted: June 15, 2017
Results First Submitted: August 17, 2020
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020