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

Takeda

Status: Terminated

Conditions: Multiple Myeloma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02761187

NSMM-5001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Is 18 years of age or older.

Is experiencing the following:

1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or
2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.

Exclusion criteria

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.

Trial design

4,253 participants in 2 patient groups

Newly Diagnosed Multiple Myeloma

Description:

Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Treatment:

Other: No Intervention

Relapsed/Refractory Multiple Myeloma

Description:

Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Treatment:

Other: No Intervention