Clinical trial · Observational
Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain
NCT03188536CI-TRIAL-00047620completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Multiple Myeloma (MM) Participants
- description
- 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.
- interventionNames
- Other: No Intervention
Primary outcomes (3)
- measure
- Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
- timeFrame
- Day 1
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDDachs 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 37539698
- DERIVEDOcio 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 37517875