Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
Study Details
Study Description
Brief Summary
The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Adult participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study.
The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected.
The study will enroll approximately 350 patients.
This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Multiple Myeloma (MM) Participants Adult participants with a diagnosis of MM who 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. |
Other: No Intervention
As it was an observational study, no intervention was administered in this study.
|
Outcome Measures
Primary Outcome Measures
- Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis [Day 1]
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).
- Percentage of MM Participants Categorized by Clinical Variables at Diagnosis [Day 1]
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).
- Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode [Day 1]
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.
Secondary Outcome Measures
- Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode [Day 1]
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.
- Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse [Day 1]
- Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 [Day 1]
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.
- HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score [Day 1]
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.
- HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) [Day 1]
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.
- Percentage of Participants With Health Care Resource Utilization (HU) [Day 1]
Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a diagnosis of MM and has received at least one previous treatment line.
-
Have experienced symptomatic relapse and/or refractory disease in the 6 months before the study.
-
Has continued in follow-up at the time of the study visit.
-
Is currently treated in the site who have clinical records available.
-
Is capable of understanding and completing the questions in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and EORTC Multiple Myeloma Module (QLQ-MY20) questionnaires.
Exclusion Criteria:
• Participants who do not agree to participate in the study or who do not give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H Universitario Puerta del Mar | Cadiz | Andalucia | Spain | 11009 |
| 2 | H Virgen de las Nieves | Granada | Andalucia | Spain | 18014 |
| 3 | Hospital Juan Ramon Jimenez | Huelva | Andalucia | Spain | 21005 |
| 4 | H Jerez | Jerez de la Frontera | Andalucia | Spain | 11408 |
| 5 | Hospital Costa del Sol | Marbella | Andalucia | Spain | 29603 |
| 6 | H. Nuestra Senora de Valme | Sevilla | Andalucia | Spain | 41014 |
| 7 | Hospital Clinico Universitario Lozano Blesa | Zaragoza | Aragon | Spain | 50009 |
| 8 | H Universitario de Cabuenes | Gijon | Asturias | Spain | 33394 |
| 9 | H U Canarias | San Cristobal de La Laguna | Canarias | Spain | 38320 |
| 10 | H Marques de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 11 | H U de Guadalajara | Guadalajara | Castilla La Mancha | Spain | 19002 |
| 12 | Complejo Hospitalario Toledo | Toledo | Castilla La Mancha | Spain | 45071 |
| 13 | Hospital de Burgos | Burgos | Castilla Y Leon | Spain | 9006 |
| 14 | Hospital de Leon | Leon | Castilla Y Leon | Spain | 24001 |
| 15 | Hospital de Salamanca | Salamanca | Castilla Y Leon | Spain | 37007 |
| 16 | Complejo Asistencial de Segovia | Segovia | Castilla Y Leon | Spain | 40002 |
| 17 | Hospital Clinico de Barcelona | Barcelona | Cataluna | Spain | 8036 |
| 18 | Hospital Doctor Trueta ICO Girona | Girona | Cataluna | Spain | 17007 |
| 19 | ICO Bellvitge | Hospitalet de Llobregat | Cataluna | Spain | 8908 |
| 20 | H Universitari de Tarragona Joan XXIII | Tarragona | Cataluna | Spain | 43005 |
| 21 | Hospital Lucus Agusti | Lugo | Galicia | Spain | 27003 |
| 22 | H Clinico Universitario de Santiago | Santiago de Compostela | Galicia | Spain | 15706 |
| 23 | H Son Espases | Palma | Islas Baleares | Spain | 7120 |
| 24 | Hospital Son Llatzer | Palma | Islas Baleares | Spain | 7198 |
| 25 | Complejo Hospitalario de Navarra | Pamplona | Navarra | Spain | 31008 |
| 26 | H de Donosti | Donostia | Pais Vasco | Spain | 20014 |
| 27 | Hospital de Txagorritxu | Vitoria-Gasteiz | Pais Vasco | Spain | 1009 |
| 28 | H Infanta Leonor | Madrid | Spain | 28031 | |
| 29 | H 12 de Octubre | Madrid | Spain | 28041 | |
| 30 | H Clinico de Valencia | Valencia | Spain | 46010 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Medical Monitor Clinical Science, Takeda
Study Documents (Full-Text)
More Information
Publications
None provided.- RRMM-5012
- TAK-MMR-2017-01
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019. |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Multiple Myeloma (MM) Participants |
|---|---|
| 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 Participants | 276 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
67.4
(10.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
129
46.7%
|
| Male |
147
53.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| Spain |
276
100%
|
| Body Mass Index (BMI) (Kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Kg/m^2] |
27.5
(5.1)
|
Outcome Measures
| Title | Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 276 |
| Age, Adults (27-90 years) |
100
36.2%
|
| Sex, Male |
53.3
19.3%
|
| Sex, Female |
46.7
16.9%
|
| BMI, 15 to 52 kg/m^2 |
100
36.2%
|
| Area of Residence, Rural |
24.3
8.8%
|
| Area of Residence, Urban |
75.7
27.4%
|
| Educational level, Illiteracy |
0.7
0.3%
|
| Educational level, No Studies (just read/write) |
10.4
3.8%
|
| Educational level, Primary studies |
43.3
15.7%
|
| Educational level, Secondary studies |
34.1
12.4%
|
| Educational level, Higher studies |
11.5
4.2%
|
| Work Status, Unemployed |
5.5
2%
|
| Work Status, Active |
5.1
1.8%
|
| Work Status, Temporary/permanent disability |
20.0
7.2%
|
| Work Status, Retired |
65.1
23.6%
|
| Work Status, Other |
4.4
1.6%
|
| Cohabitation status, Living Alone |
12.4
4.5%
|
| Cohabitation status, Living with Relatives |
85.8
31.1%
|
| Cohabitation, Living Alone with Assistance |
1.8
0.7%
|
| Need of Financial Support, No |
93.8
34%
|
| Level of Dependence, Independent |
71.3
25.8%
|
| Level of Dependence, Grade I |
14.5
5.3%
|
| Level of Dependence, Grade II |
12.7
4.6%
|
| Level of Dependence, Grade III |
1.5
0.5%
|
| Physical Activity, High |
1.8
0.7%
|
| Physical Activity, Moderate |
45.8
16.6%
|
| Physical Activity, Inactive |
52.4
19%
|
| Current smoking habit, Yes |
3.6
1.3%
|
| Current smoking habit, No |
96.4
34.9%
|
| Alcohol Use, Yes |
6.5
2.4%
|
| Alcohol Use, No |
93.5
33.9%
|
| Title | Percentage of MM Participants Categorized by Clinical Variables at Diagnosis |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 276 |
| Age, Adults (27-90 years) |
100
36.2%
|
| MM Type, Heavy chain, IgA |
24.1
8.7%
|
| MM Type, Heavy chain, IgD |
1.9
0.7%
|
| MM Type, Heavy chain, IgG |
56.8
20.6%
|
| MM Type, Heavy chain, IgM |
0.8
0.3%
|
| MM Type, Heavy chain, No Heavy Chain |
16.5
6%
|
| MM Type, Light Chain, No Light Chain |
3.3
1.2%
|
| MM Type, Light Chain, Kappa |
59.8
21.7%
|
| MM Type, Light Chain, Lambda |
37.0
13.4%
|
| MM Type, Bence Jones Protein, Yes |
53.6
19.4%
|
| ISS Disease Stage I |
28.8
10.4%
|
| ISS Disease Stage II |
28.1
10.2%
|
| ISS Disease Stage III |
43.1
15.6%
|
| CRAB Signs, None |
12.7
4.6%
|
| CRAB Signs, Some, Increase in blood calcium levels |
12.0
4.3%
|
| CRAB Signs, Some, Renal failure |
18.7
6.8%
|
| CRAB Signs, Some, Anemia |
52.7
19.1%
|
| CRAB Signs, Some, Bone lesions |
76.3
27.6%
|
| Cytogenetic abnormalities, t (4;14) |
11.3
4.1%
|
| Cytogenetic abnormalities, t (11;14) |
14.2
5.1%
|
| Cytogenetic abnormalities, t (14;16) |
1.9
0.7%
|
| Cytogenetic abnormalities, Trisomies |
3.8
1.4%
|
| Cytogenetic abnormalities, d (17p) |
17.9
6.5%
|
| Cytogenetic abnormalities, g (1q) |
21.7
7.9%
|
| Cytogenetic abnormalities, Other |
66.0
23.9%
|
| Risk, High |
19.8
7.2%
|
| Risk, Standard |
12.3
4.5%
|
| Risk, Intermediate |
23.6
8.6%
|
| Risk, Other |
44.3
16.1%
|
| ECOG Status, 0 |
29.7
10.8%
|
| ECOG Status, 1 |
41.5
15%
|
| ECOG Status, 2 |
22.6
8.2%
|
| ECOG Status, 3 |
6.2
2.2%
|
| Title | Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 276 |
| Relapse Within 6 Months of Last Relapse |
61.6
22.3%
|
| ISS Disease Stage I |
37.4
13.6%
|
| ISS Disease Stage II |
35.5
12.9%
|
| ISS Disease Stage III |
27.0
9.8%
|
| CRAB Signs, None |
25.7
9.3%
|
| CRAB Signs, Some-Increase in blood calcium levels |
9.3
3.4%
|
| CRAB Signs, Some-Renal Failure |
20.5
7.4%
|
| CRAB Signs, Some-Anemia |
43.9
15.9%
|
| CRAB Signs, Some-Bone lesions |
65.9
23.9%
|
| Cytogenetic Abnormalities, t(4;14) |
11.5
4.2%
|
| Cytogenetic Abnormalities, t(11;14) |
8.0
2.9%
|
| Cytogenetic Abnormalities, t(14;16) |
5.7
2.1%
|
| Cytogenetic Abnormalities, Trisomies |
4.6
1.7%
|
| Cytogenetic Abnormalities, d (17p) |
19.5
7.1%
|
| Cytogenetic Abnormalities, g (1q) |
27.96
10.1%
|
| Cytogenetic Abnormalities, other |
64.4
23.3%
|
| Risk, High |
38.8
14.1%
|
| Risk, Standard |
12.2
4.4%
|
| Risk, Intermediate |
49.0
17.8%
|
| Diffuse osteopathy |
15.4
5.6%
|
| Fractures |
15.2
5.5%
|
| Neurological symptoms |
8.0
2.9%
|
| Infections |
15.2
5.5%
|
| Comorbidities, Diabetes |
24.6
8.9%
|
| Comorbidities, Neuropathy |
20.6
7.5%
|
| Comorbidities, Nephropathy |
15.4
5.6%
|
| Comorbidity, COPD |
11.4
4.1%
|
| Comorbidities, Cardiovascular disease |
48.6
17.6%
|
| Comorbidities, Liver failure |
1.7
0.6%
|
| Comorbidities,Psychiatric or Neurological Disorder |
14.3
5.2%
|
| Comorbidities, Other secondary disorders |
45.7
16.6%
|
| Medullary Plasmacytoma |
15.3
5.5%
|
| Extramedullary Plasmacytoma |
15.6
5.7%
|
| Anti-CD38 mAb Monotherapy, Second Line |
0.9
0.3%
|
| Anti-CD38 mAb Monotherapy, Third Line |
13.2
4.8%
|
| Anti-CD38 mAb Monotherapy, Fourth Line or Later |
20.3
7.4%
|
| Double PI Therapy+Steroids/Alkylating Agent,2 Line |
9.8
3.6%
|
| Double PI therapy+Steroids/Alkylating Agent,3 Line |
10.3
3.7%
|
| DoublePI Therapy+Steroids/Alkylating Agent,>=4Line |
6.3
2.3%
|
| Autologous transplant, Second Line |
2.5
0.9%
|
| Autologous transplant, Third Line |
7.0
2.5%
|
| Autologous transplant, Fourth Line or Later |
1.2
0.4%
|
| Allogeneic transplant, Second Line |
0.8
0.3%
|
| Allogeneic transplant, Third Line |
1.4
0.5%
|
| Allogeneic transplant, Fourth Line or Later |
2.4
0.9%
|
| Autologous or Allogeneic Transplant, Second Line |
2.5
0.9%
|
| Autologous or Allogeneic Transplant, Third Line |
8.5
3.1%
|
| Autologous or Allogeneic Transplant, >=4 Lines |
3.5
1.3%
|
| Title | Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 276 |
| Age, 38-85 years, IMiDs |
100
36.2%
|
| Age, 43-76 years, PI + IMiDs |
100
36.2%
|
| Age, 47-84 years, PI |
100
36.2%
|
| Age, 39-80 years, mAb |
100
36.2%
|
| Age, 53-90 years, Other |
100
36.2%
|
| Sex, Male, IMiDs |
49.4
17.9%
|
| Sex, Female, IMiDs |
50.6
18.3%
|
| Sex, Male, PI + IMiDs |
61.2
22.2%
|
| Sex, Female, PI + IMiDs |
38.8
14.1%
|
| Sex, Male, PI |
47.1
17.1%
|
| Sex, Female, PI |
52.9
19.2%
|
| Sex, Male, mAb |
55.7
20.2%
|
| Sex, Female, mAb |
44.3
16.1%
|
| Sex, Male, Other |
57.7
20.9%
|
| Sex, Female, Other |
42.3
15.3%
|
| Prior lines of treatment, 1, IMiDs |
50.6
18.3%
|
| Prior lines of treatment, 2, IMiDs |
28.1
10.2%
|
| Prior lines of treatment, 3 or more, IMiDs |
21.3
7.7%
|
| Prior lines of treatment, 1, PI + IMiDs |
63.3
22.9%
|
| Prior lines of treatment, 2, PI + IMiDs |
16.3
5.9%
|
| Prior lines of treatment, 3 or more, PI + IMiDs |
20.4
7.4%
|
| Prior lines of treatment, 1, PI |
44.1
16%
|
| Prior lines of treatment, 2, PI |
35.3
12.8%
|
| Prior lines of treatment, 3 or more, PI |
20.6
7.5%
|
| Prior lines of treatment, 1, mAb |
26.2
9.5%
|
| Prior lines of treatment, 2, mAb |
29.5
10.7%
|
| Prior lines of treatment, 3 or more, mAb |
44.3
16.1%
|
| Prior lines of treatment, 1, Other |
11.5
4.2%
|
| Prior lines of treatment, 2, Other |
26.9
9.7%
|
| Prior lines of treatment, 3 or more, Other |
61.5
22.3%
|
| Number of prior relapses, 0, IMiDs |
43.8
15.9%
|
| Number of prior relapses, 1, IMiDs |
31.5
11.4%
|
| Number of prior relapses, 2, IMiDs |
12.4
4.5%
|
| Number of prior relapses, 3 and more, IMiDs |
12.4
4.5%
|
| Number of prior relapses, 0, PI + IMiDs |
49.0
17.8%
|
| Number of prior relapses, 1, PI + IMiDs |
36.7
13.3%
|
| Number of prior relapses, 2, PI + IMiDs |
2.0
0.7%
|
| Number of prior relapses, 3 or more, PI + IMiDs |
12.2
4.4%
|
| Number of prior relapses, 0, PI |
47.1
17.1%
|
| Number of prior relapses, 1, PI |
32.4
11.7%
|
| Number of prior relapses, 2, PI |
2.9
1.1%
|
| Number of prior relapses, 3 or more, PI |
17.6
6.4%
|
| Number of prior relapses, 0, mAb |
27.9
10.1%
|
| Number of prior relapses, 1, mAb |
26.2
9.5%
|
| Number of prior relapses, 2, mAb |
18.0
6.5%
|
| Number of prior relapses, 3 or more, mAb |
27.9
10.1%
|
| Number of prior relapses, 0, Other |
11.5
4.2%
|
| Number of prior relapses, 1, Other |
26.9
9.7%
|
| Number of prior relapses, 2, Other |
23.1
8.4%
|
| Number of prior relapses, 3 or more, Other |
38.5
13.9%
|
| ISS Disease Stage I, IMiDs |
38.5
13.9%
|
| ISS Disease Stage II, IMiDs |
38.5
13.9%
|
| ISS Disease Stage III, IMiDs |
23.1
8.4%
|
| ISS Disease Stage I, PI + IMiDs |
51.3
18.6%
|
| ISS Disease Stage II, PI + IMiDs |
28.2
10.2%
|
| ISS Disease Stage III, PI + IMiDs |
20.5
7.4%
|
| ISS Disease Stage I, PI |
20.8
7.5%
|
| ISS Disease Stage II, PI |
54.2
19.6%
|
| ISS Disease Stage III, PI |
25.0
9.1%
|
| ISS Disease Stage I, mAb |
40.0
14.5%
|
| ISS Disease Stage II, mAb |
32.0
11.6%
|
| ISS Disease Stage III, mAb |
28.0
10.1%
|
| ISS Disease Stage I, Other |
23.8
8.6%
|
| ISS Disease Stage II, Other |
23.8
8.6%
|
| ISS Disease Stage III, Other |
52.4
19%
|
| CRAB Signs, None, IMiDs |
29.2
10.6%
|
| CRAB Signs, Some, IMiDs |
70.8
25.7%
|
| CRAB Signs, None, PI + IMiDs |
14.3
5.2%
|
| CRAB Signs, Some, PI + IMiDs |
85.7
31.1%
|
| CRAB Signs, None, PI |
20.6
7.5%
|
| CRAB Signs, Some, PI |
79.4
28.8%
|
| CRAB Signs, None, mAb |
31.1
11.3%
|
| CRAB Signs, Some, mAb |
68.9
25%
|
| CRAB Signs, None, Other |
23.1
8.4%
|
| CRAB Signs, Some, Other |
76.9
27.9%
|
| Comorbidities, None, IMiDs |
41.6
15.1%
|
| Comorbidities, Some, IMiDs |
58.4
21.2%
|
| Comorbidities, None, PI + IMiDs |
49.0
17.8%
|
| Comorbidities, Some, PI + IMiDs |
51.0
18.5%
|
| Comorbidities, None, PI |
35.3
12.8%
|
| Comorbidities, Some, PI |
64.7
23.4%
|
| Comorbidities, None, mAb |
32.8
11.9%
|
| Comorbidities, Some, mAb |
67.2
24.3%
|
| Comorbidities, None, Other |
23.1
8.4%
|
| Comorbidities, Some, Other |
76.9
27.9%
|
| Risk, High, IMiDs |
50.0
18.1%
|
| Risk, Standard, IMiDs |
50.0
18.1%
|
| Risk, High, PI + IMiDs |
41.7
15.1%
|
| Risk, Standard, PI + IMiDs |
58.3
21.1%
|
| Risk, High, PI |
50.0
18.1%
|
| Risk, Standard, PI |
50.0
18.1%
|
| Risk, High, mAb |
60.0
21.7%
|
| Risk, Standard, mAb |
40.0
14.5%
|
| Risk, High, Other |
50.0
18.1%
|
| Risk, Standard, Other |
50.0
18.1%
|
| Medullary Plasmacytoma, Yes, IMiDs |
15.5
5.6%
|
| Medullary Plasmacytoma, No, IMiDs |
84.5
30.6%
|
| Medullary Plasmacytoma, Yes, PI + IMiDs |
25.0
9.1%
|
| Medullary Plasmacytoma, No, PI + IMiDs |
75.0
27.2%
|
| Medullary Plasmacytoma, Yes, PI |
14.7
5.3%
|
| Medullary Plasmacytoma, No, PI |
85.3
30.9%
|
| Medullary Plasmacytoma, Yes, mAb |
8.6
3.1%
|
| Medullary Plasmacytoma, No, mAb |
91.4
33.1%
|
| Medullary Plasmacytoma, Yes, Other |
16.0
5.8%
|
| Medullary Plasmacytoma, No, Other |
84.0
30.4%
|
| Extramedullary Plasmacytoma, Yes, IMiDs |
12.8
4.6%
|
| Extramedullary Plasmacytoma, No, IMiDs |
87.2
31.6%
|
| Extramedullary Plasmacytoma, Yes, PI + IMiDs |
33.3
12.1%
|
| Extramedullary Plasmacytoma, No, PI + IMiDs |
66.7
24.2%
|
| Extramedullary Plasmacytoma, Yes, PI |
11.8
4.3%
|
| Extramedullary Plasmacytoma, No, PI |
88.2
32%
|
| Extramedullary Plasmacytoma, Yes, mAb |
6.7
2.4%
|
| Extramedullary Plasmacytoma, No, mAb |
93.3
33.8%
|
| Extramedullary Plasmacytoma, Yes, Other |
24.0
8.7%
|
| Extramedullary Plasmacytoma, No, Other |
76.0
27.5%
|
| Osteopenia, Yes, IMiDs |
23.9
8.7%
|
| Osteopenia, No, IMiDs |
76.1
27.6%
|
| Osteopenia, Yes, PI + IMiDs |
6.3
2.3%
|
| Osteopenia, No, PI + IMiDs |
93.8
34%
|
| Osteopenia, Yes, PI |
8.8
3.2%
|
| Osteopenia, No, PI |
91.2
33%
|
| Osteopenia, Yes, mAb |
13.3
4.8%
|
| Osteopenia, No, mAb |
86.7
31.4%
|
| Osteopenia, Yes, Other |
23.1
8.4%
|
| Osteopenia, No, Other |
76.9
27.9%
|
| Fractures, Yes, IMiDs |
15.7
5.7%
|
| Fractures, No, IMiDs |
84.3
30.5%
|
| Fractures, Yes, PI + IMiDs |
18.4
6.7%
|
| Fractures, No, PI + IMiDs |
81.6
29.6%
|
| Fractures, Yes, PI |
11.8
4.3%
|
| Fractures, No, PI |
88.2
32%
|
| Fractures, Yes, mAb |
14.8
5.4%
|
| Fractures, No, mAb |
85.2
30.9%
|
| Fractures, Yes, Other |
15.4
5.6%
|
| Fractures, No, Other |
84.6
30.7%
|
| Neurological Symptoms, Yes, IMiDs |
10.1
3.7%
|
| Neurological Symptoms, No, IMiDs |
89.9
32.6%
|
| Neurological Symptoms, Yes, PI + IMiDs |
10.2
3.7%
|
| Neurological Symptoms, No, PI + IMiDs |
89.8
32.5%
|
| Neurological Symptoms, Yes, PI |
5.9
2.1%
|
| Neurological Symptoms, No, PI |
94.1
34.1%
|
| Neurological Symptoms, Yes, mAb |
1.6
0.6%
|
| Neurological Symptoms, No, mAb |
98.4
35.7%
|
| Neurological Symptoms, Yes, Other |
11.5
4.2%
|
| Neurological Symptoms, No, Other |
88.5
32.1%
|
| MM Related Neurological Symptoms, Yes, IMiDs |
5.6
2%
|
| MM Related Neurological Symptoms, No, IMiDs |
94.4
34.2%
|
| MM Related Neurological Symptoms, Yes, PI + IMiDs |
8.2
3%
|
| MM Related Neurological Symptoms, No, PI + IMiDs |
91.8
33.3%
|
| MM Related Neurological Symptoms, Yes, PI |
5.9
2.1%
|
| MM Related Neurological Symptoms, No, PI |
94.1
34.1%
|
| MM Related Neurological Symptoms, Yes, mAb |
0.0
0%
|
| MM Related Neurological Symptoms, No, mAb |
100.0
36.2%
|
| MM Related Neurological Symptoms, Yes, Other |
7.7
2.8%
|
| MM Related Neurological Symptoms, No, Other |
92.3
33.4%
|
| Infections, Yes, IMiDs |
14.6
5.3%
|
| Infections, No, IMiDs |
85.4
30.9%
|
| Infections, Yes, PI + IMiDs |
20.4
7.4%
|
| Infections, No, PI + IMiDs |
79.6
28.8%
|
| Infections, Yes, PI |
14.7
5.3%
|
| Infections, No, PI |
85.3
30.9%
|
| Infections, Yes, mAb |
11.5
4.2%
|
| Infections, No, mAb |
88.5
32.1%
|
| Infections, Yes, Other |
11.5
4.2%
|
| Infections, No, Other |
88.5
32.1%
|
| Title | Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse |
|---|---|
| Description | |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected for this outcome measure. |
| Arm/Group Title | Multiple Myeloma (MM) Participants |
|---|---|
| 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. |
| Measure Participants | 0 |
| Measure Variables | 0 |
| Title | Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 273 |
| Mean (Standard Deviation) [score on a scale] |
53.5
(23.9)
|
| Title | HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 273 |
| 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)
|
| Title | HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 276 |
| Future perspective, Factors I-II |
60.3
(28.2)
|
| Future perspective, Factors III |
53.9
(24.9)
|
| Body image, Factors I-II |
73.9
(35.5)
|
| Body image, Factors III |
73.0
(32.7)
|
| Symptoms of the disease, Factors I-II |
31.9
(23.6)
|
| Symptoms of the disease, Factors III |
27.3
(22.1)
|
| Adverse effects of the treatment, Factors I-II |
24.3
(16.9)
|
| Adverse effects of the treatment, Factors III |
29.0
(17.5)
|
| Title | Percentage of Participants With Health Care Resource Utilization (HU) |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants eligible for analyses were included. |
| Arm/Group Title | Multiple Myeloma (MM) Participants |
|---|---|
| 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. |
| Measure Participants | 276 |
| Admitted at some healthcare service |
56.2
20.4%
|
| Admitted to Hospital |
59.4
21.5%
|
| Used ambulance to attend to the hospital |
7.0
2.5%
|
| Used their own transport |
67.8
24.6%
|
| Consultation with the primary care physician |
21.7
7.9%
|
| Consultation with the oncologist |
2.5
0.9%
|
| Consultation with the psychologist |
3.6
1.3%
|
| Attended psychologist |
60
21.7%
|
| Attended hematologist |
89.1
32.3%
|
| Required some test |
82.2
29.8%
|
| Had undergone X-ray test |
43.2
15.7%
|
Adverse Events
| 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 | |
| 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 (%) | # Events | |
| Total | 0/276 (0%) | |
Serious Adverse Events |
||
| Multiple Myeloma (MM) Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Multiple Myeloma (MM) Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
- RRMM-5012
- TAK-MMR-2017-01