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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04135963
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Portugal
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapse and/or Refractory Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

: Participants with MM

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Braga, Portugal

Status

Not yet recruiting

Address

Centro Clinico Academico Hospital de Braga

Braga, , 4710-243

Coimbra, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar e Universitario de Coimbra. EPE

Coimbra, , 3004-561

Lisboa, Portugal

Status

Not yet recruiting

Address

Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPO)

Lisboa, , 1099-023

Lisboa, Portugal

Status

Recruiting

Address

Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria

Lisboa, , 1649-028

Porto, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar Universitario do Porto, E.P.E.

Porto, , 4099-001

Porto, Portugal

Status

Not yet recruiting

Address

Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

Porto, , 4200-072

Porto, Portugal

Status

Recruiting

Address

Centro Hospitalar Universitario de Sao Joao, EPE,

Porto, , 4200-319

Vila Nova de Gaia, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE,

Vila Nova de Gaia, , 4434-502