N/A
Completed N=282
Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
Multiple Myeloma
Source: ClinicalTrials.gov NCT03188536 ↗
Enrolled (actual)
282
Serious AEs
—
Results posted
Oct 2020
Primary outcomePrimary: Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis — 100; 53.3; 46.7; 100 percentage of participants
Summary
The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis |
100; 53.3; 46.7; 100; 24.3; 75.7 | — |
| PRIMARY Percentage of MM Participants Categorized by Clinical Variables at Diagnosis |
100; 24.1; 1.9; 56.8; 0.8; 16.5 | — |
| PRIMARY Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode |
61.6; 37.4; 35.5; 27.0; 25.7; 9.3 | — |
| SECONDARY Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode |
100; 100; 100; 100; 100; 49.4 | — |
| SECONDARY Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse |
— | — |
| SECONDARY Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 |
53.5 | — |
| SECONDARY HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score |
58.4; 72.9; 30.7; 25.4 | — |
| SECONDARY HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) |
60.3; 53.9; 73.9; 73.0; 31.9; 27.3 | — |
| SECONDARY Percentage of Participants With Health Care Resource Utilization (HU) |
56.2; 59.4; 7.0; 67.8; 21.7; 2.5 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03188536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.