A Study of Real Life Treatment for Multiple Myeloma (MM) (LEADER)

Takeda

Status: Active, not recruiting

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT04985643

C16058

Details and patient eligibility

About

The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study.

Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Full description

This is a non-interventional, prospective study of participants with MM relapses. This study will assess the low detection rate of biochemical relapses which will improve routine clinical practices and management of participants with MM in real world practice.

The study will enroll approximately 350 participants. The data will be collected both prospectively and/or retrospectively at the specialized care (hematology) and will be recorded into electronic case report forms (e-CRFs) of the electronic data capture (EDC) system. All the participants will be assigned to a single observational cohort:

• Participants With MM

This multi-center study will be conducted in the Russian Federation. The overall duration of the study will be approximately 4 years. The overall time for treatment and follow-up period will be approximately 2.5 years for each participant.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.

Exclusion criteria

1. With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion.
2. Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.

Trial design

357 participants in 1 patient group

Participants With MM

Description:

Participants diagnosed with MM (complete response \[CR\], very good partial response \[VGPR\] and partial response \[PR\]) and who have received one prior first line treatment within 3 months preceding the enrollment, will be observed retrospectively and medical data will be monitored and collected prospectively every 3 months until the second biochemical and symptomatic relapse is identified.