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

NCT ID: NCT04985643

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 357 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2026-06-20

Brief Summary

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.

Detailed 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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants With MM

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Altai Regional Clinical Hospital

Barnaul, Altayskiy Kray, Russia

Kaluga Regional Clinical Hospital

Kaluga, Central Federal District, Russia

Smolensk Clinical Hospital of Russian Railways-Medicine

Smolensk, Central Federal District, Russia

City Clinical Hospital No. 1 named after prof. S.I.Sergeev

Khabarovsk, Far Eastern Federal District, Russia

Kirov Research Institute of Hematology and Blood Transfusion

Kirov, Kirov Oblast, Russia

GUZ "Lipetsk City Hospital No. 3" Free Falcon "

Lipetsk, Lipetsk Oblast, Russia

National Research Center of Hematology of the Ministry of Health

Moscow, Moscow Oblast, Russia

Herzen Moscow Scientific Research Oncological Institute

Moscow, Moscow Oblast, Russia

Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky

Moscow, Moscow Oblast, Russia

BaltikMed Clinic

Kaliningrad, Northwestern Federal District, Russia

Vologda Regional Clinical Hospital

Vologda, Northwestern Federal District, Russia

Novosibirsk State Medical University, Department of Therapy, Hematology and Transfusiology based on City Clinical Hospital No. 2

Novosibirsk, Novosibirsk Oblast, Russia

Orenburgskaya Regional Clinical Hospital n.a. V.I. Voinova

Orenburg, Orenburgskaya District, Russia

Republican hospital named after V.A.Baranov

Petrozavodsk, Republic of Karelia, Russia

Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

Kazan', Republic Tatarstan, Russia

City Clinical Hospital No. 31

Saint Petersburg, Sankt-Peterburg, Russia

Razumovskiy Saratov State Medical University, University Clinical

Saratov, Saratov Oblast, Russia

Tomsk Regional Clinical Hospital

Tomsk, Siberian Federal District, Russia

District Clinical Hospital

Khanty-Mansiysk, Tyumen Oblast, Russia

Surgut Regional Clinical Hospital

Surgut, Tyumen Oblast, Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, Russia

City Clinical Hospital No. 12

Nizhny Novgorod, Volga Federal District, Russia

Clinic Akademicheskaya LLC

Volgograd, Volgogradskaya District, Russia

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, , Russia

Countries

Russia

Related Links

https://clinicaltrials.takeda.com/study-detail/611151a5cd353f0032b92051

To obtain more information on the study, click here/on this link

Other Identifiers

C16058

Identifier Type: -

Identifier Source: org_study_id