Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
2 other identifiers
observational
282
1 country
30
Brief Summary
The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedOctober 12, 2020
September 1, 2020
1.3 years
June 12, 2017
August 17, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Secondary Outcomes (6)
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
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
Day 1
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Day 1
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Day 1
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
As it was an observational study, no intervention was administered in this study.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Participants who do not agree to participate in the study or who do not give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (30)
H Universitario Puerta del Mar
Cadiz, Andalusia, 11009, Spain
H Virgen de las Nieves
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
Related Publications (2)
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.
PMID: 37539698DERIVEDOcio 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.
PMID: 37517875DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Monitor Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 15, 2017
Study Start
July 26, 2017
Primary Completion
November 15, 2018
Study Completion
January 30, 2019
Last Updated
October 12, 2020
Results First Posted
October 12, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
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.