NCT02761187

An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4,253 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed \[ND\] multiple myeloma (MM) and participants with relapsed/refractory \[R/R\] MM.

Detailed description

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits. The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM: * ND MM within 3 months from initiation of treatment * R/R MM who have received 1 to 3 prior lines of therapy This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	No Intervention	As this was an observational study, no intervention was administered.

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2016-05-04
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

137 sites across 15 countries: United States, Belgium, Brazil, China, Colombia, France, Germany, Greece, Israel, Italy, Mexico, Spain, Taiwan, Turkey (Türkiye), United Kingdom