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| ID | Type | Description | Link |
|---|---|---|---|
| TAK-MMR-2017-01 | Registry Identifier | Spanish health authority |
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The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | As it was an observational study, no intervention was administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis | 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). | Day 1 |
| Percentage of MM Participants Categorized by Clinical Variables at Diagnosis | 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). | Day 1 |
| Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode | 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Participants who do not agree to participate in the study or who do not give written informed consent.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Universitario Puerta del Mar | Cadiz | Andalusia | 11009 | Spain | ||
| H Virgen de las Nieves |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37539698 | Derived | Dachs LR, Gaisan CM, Bustamante G, Lopez SG, Garcia EG, Persona EP, Gonzalez-Calle V, Auzmendi MS, Perez JMA, Gonzalez Montes Y, Rios Tamayo R, de Miguel Llorente D, Bernal LP, Mayol AS, Caro CC, Grande M, Fernandez-Nistal A, Naves A, Miguel EMOS. Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study. Leuk Lymphoma. 2023 Nov-Dec;64(11):1847-1856. doi: 10.1080/10428194.2023.2240922. Epub 2023 Aug 4. | |
| 37517875 |
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Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with a diagnosis of multiple myeloma with symptomatic relapse and/or refractory disease were observed to collect the retrospective data on Day 1.
Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2017 |
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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. |
| Day 1 |
| Day 1 |
| 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 | 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. | Day 1 |
| HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score | 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. | Day 1 |
| HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) | 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. | Day 1 |
| Percentage of Participants With Health Care Resource Utilization (HU) | Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted. | Day 1 |
| Granada |
| Andalusia |
| 18014 |
| Spain |
| Hospital Juan Ramon Jimenez | Huelva | Andalusia | 21005 | Spain |
| H Jerez | Jerez de la Frontera | Andalusia | 11408 | Spain |
| Hospital Costa del Sol | Marbella | Andalusia | 29603 | Spain |
| H. Nuestra Senora de Valme | Seville | Andalusia | 41014 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Aragon | 50009 | Spain |
| H Son Espases | Palma | Balearic Islands | 7120 | Spain |
| Hospital Son Llatzer | Palma | Balearic Islands | 7198 | Spain |
| H de Donosti | Donostia / San Sebastian | Basque Country | 20014 | Spain |
| Hospital de Txagorritxu | Vitoria-Gasteiz | Basque Country | 1009 | Spain |
| H U Canarias | San Cristóbal de La Laguna | Canary Islands | 38320 | Spain |
| H Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital de Burgos | Burgos | Castille and León | 9006 | Spain |
| Hospital de Leon | León | Castille and León | 24001 | Spain |
| Hospital de Salamanca | Salamanca | Castille and León | 37007 | Spain |
| Complejo Asistencial de Segovia | Segovia | Castille and León | 40002 | Spain |
| H U de Guadalajara | Guadalajara | Castille-La Mancha | 19002 | Spain |
| Complejo Hospitalario Toledo | Toledo | Castille-La Mancha | 45071 | Spain |
| Hospital Clinico de Barcelona | Barcelona | Catalonia | 8036 | Spain |
| Hospital Doctor Trueta ICO Girona | Girona | Catalonia | 17007 | Spain |
| ICO Bellvitge | L'Hospitalet de Llobregat | Catalonia | 8908 | Spain |
| H Universitari de Tarragona Joan XXIII | Tarragona | Catalonia | 43005 | Spain |
| Hospital Lucus Agusti | Lugo | Galicia | 27003 | Spain |
| H Clinico Universitario de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | 31008 | Spain |
| H Universitario de Cabuenes | Gijón | Principality of Asturias | 33394 | Spain |
| H Infanta Leonor | Madrid | 28031 | Spain |
| H 12 de Octubre | Madrid | 28041 | Spain |
| H Clinico de Valencia | Valencia | 46010 | Spain |
| Derived |
| Ocio EM, Montes-Gaisan C, Bustamante G, Garzon S, Gonzalez E, Perez-Persona E, Gonzalez-Calle V, Sirvent M, Arguinano JM, Gonzalez Y, Rios R, de Miguel D, Grande M, Fernandez-Nistal A, Naves A, Rosinol L. Real-World Health Care Services Utilization Associated With the Management of Patients With Relapsed and Refractory Multiple Myeloma in Spain: The CharisMMa Study. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e341-e347. doi: 10.1016/j.clml.2023.07.006. Epub 2023 Jul 15. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants eligible for analyses were included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | BMI=Weight (kg)/Height(m)^2. | Mean | Standard Deviation | Kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis | 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). | 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. | Posted | Number | percentage of participants | Day 1 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of MM Participants Categorized by Clinical Variables at Diagnosis | 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). | 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. | Posted | Number | percentage of participants | Day 1 |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode | 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. | 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. | Posted | Number | percentage of participants | Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode | 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. | 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. | Posted | Number | percentage of participants | Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse | Data was not collected for this outcome measure. | Posted | Day 1 | Variables | Variables |
|
| ||||||||||||||||||||||||||||||
| Secondary | Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 | 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. | All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
| ||||||||||||||||||||||||||||
| Secondary | HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score | 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. | All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses. | Posted | Mean | Standard Deviation | score on scale | Day 1 |
|
| ||||||||||||||||||||||||||||
| Secondary | HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) | 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. | All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Health Care Resource Utilization (HU) | Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted. | All participants eligible for analyses were included. | Posted | Number | percentage of participants | Day 1 |
|
|
From enrollment on 26 July 2017 to last date of assessment 30 January 2019 (Up to 1.5 years)
Data of adverse events or adverse drug reactions were not collected as part of the study database.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 276 | 0 | 0 | 0 | 0 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Aug 17, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
|
| Sex, Female |
|
|
| BMI, 15 to 52 kg/m^2 |
|
|
| Area of Residence, Rural |
|
|
| Area of Residence, Urban |
|
|
| Educational level, Illiteracy |
|
|
| Educational level, No Studies (just read/write) |
|
|
| Educational level, Primary studies |
|
|
| Educational level, Secondary studies |
|
|
| Educational level, Higher studies |
|
|
| Work Status, Unemployed |
|
|
| Work Status, Active |
|
|
| Work Status, Temporary/permanent disability |
|
|
| Work Status, Retired |
|
|
| Work Status, Other |
|
|
| Cohabitation status, Living Alone |
|
|
| Cohabitation status, Living with Relatives |
|
|
| Cohabitation, Living Alone with Assistance |
|
|
| Need of Financial Support, No |
|
|
| Level of Dependence, Independent |
|
|
| Level of Dependence, Grade I |
|
|
| Level of Dependence, Grade II |
|
|
| Level of Dependence, Grade III |
|
|
| Physical Activity, High |
|
|
| Physical Activity, Moderate |
|
|
| Physical Activity, Inactive |
|
|
| Current smoking habit, Yes |
|
|
| Current smoking habit, No |
|
|
| Alcohol Use, Yes |
|
|
| Alcohol Use, No |
|
|
|
|
| Units | Counts |
|---|
| Participants |
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| Variables |
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| Counts |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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