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Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)

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Takeda

Status

Completed

Conditions

Multiple Myeloma

Treatments

Other: No Intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT03188536
RRMM-5012
TAK-MMR-2017-01 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.

Full description

Adult participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study.

The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected.

The study will enroll approximately 350 patients.

This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

282 participants in 1 patient group

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.
Treatment:
Other: No Intervention

Trial documents
1

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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