Clinical trial NCT04135963: A Study of People With Multiple Myeloma (MM) in Portugal (CharisMMa-Portugal)
Official title: Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Portugal: an Observational, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapse and/or Refractory Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a diagnosis of MM with symptomatic R/R disease receiving treatment in Portugal.

Brief summary: The main aim of this study is to see how people with MM respond to previous or current treatment.

Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Information collected from past medical records will also be used.

Detailed description: This is a non- interventional, retrospective epidemiological study of participants with MM. The study will characterize MM participants with symptomatic relapse and/or refractory (R/R) disease.

The study will enroll approximately 151 participants. The study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (QoL) will be obtained from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-MY20 questionnaires. All participants will be enrolled in one observational group.

This multi-center trial will be conducted in Portugal. The overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.

Eligibility criteria: Inclusion Criteria:

1. At least one previous treatment line.
2. Symptomatic R/R disease in the previous 6 months to study enrolment.
3. Receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site.
4. On regular follow-up for relapse and/or refractory disease during the recruitment period at the study site.
5. Capable of understanding and completing both QoL questionnaires (EORTC QLQ-C30 and EORTC QLQ-MY20).

Exclusion Criteria:

1. Diagnosed with MM more than 5 years previous to inclusion in this study.
2. Diagnosed with any malignancy other than MM or its complications within the past 5 years.
3. Currently participating in a clinical trial for his MM or having participated in a clinical trial within 5 years before inclusion.
4. Diagnosed with any hematological disease other than MM or its complications.

Primary outcomes:
measure: Number of MM Participants Categorized by Sociodemographic Variables
timeFrame: Day 1
measure: Number of MM Participants Categorized by Clinical Variables on Diagnosis and During Previous Relapses
timeFrame: Day 1
measure: Number of MM Participants Categorized by Clinical Variables at Last R/R Episode
timeFrame: Day 1
measure: Number of Participants Categorized by Current Treatment
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants Categorized by Sociodemographic Characteristics at the Latest Symptomatic R/R Episode per Type of Treatment
timeFrame: Day 1
measure: Number of MM Participants Categorized by Clinical Variables at Latest Symptomatic R/R Episode per Type of MM
timeFrame: Day 1
measure: Number of Participants Categorized by Relevant Variables that are not Currently Collected in Clinical Record and Could Influence in the Disease Management at Relapse
timeFrame: Day 1
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Centro Clinico Academico Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra. EPE
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPO)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, E.P.E.
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE,
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE,
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: