A Study of People With Multiple Myeloma (MM) in Portugal (CharisMMa-Portugal)

Takeda

Status: Completed

Conditions: Relapse and/or Refractory Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT04135963

U1111-1234-4861 (Registry Identifier)

RRMM-5017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

62 participants in 1 patient group

Participants with MM

Description:

Participants diagnosed with MM from 8 investigative sites will be observed retrospectively for previous 5 years before enrollment until Day 1.