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

Last updated: April 3, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Bone Neoplasm

Bone Diseases

Leukemia

Treatment

N/A

Clinical Study ID

NCT04985643
C16058
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for ahigh-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had aresponse (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 timeof inclusion.

Exclusion

Exclusion Criteria:

  1. With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to theongoing standard of care (SoC) induction (1st line) therapy that has been startedwithin 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.

Study Design

Total Participants: 357
Study Start date:
February 18, 2022
Estimated Completion Date:
August 30, 2025

Study 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.

Connect with a study center

  • Altai Regional Clinical Hospital

    Barnaul, Altay Region 656024
    Russian Federation

    Site Not Available

  • Bryansk Regional Hospital No. 1

    Bryansk, Bryansk Region 241033
    Russian Federation

    Site Not Available

  • Kaluga Regional Clinical Hospital

    Kaluga, Central Federal District 248007
    Russian Federation

    Site Not Available

  • Smolensk Clinical Hospital of Russian Railways-Medicine

    Smolensk, Central Federal District 214025
    Russian Federation

    Site Not Available

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

    Khabarovsk, Far Eastern Federal District 680009
    Russian Federation

    Site Not Available

  • Kirov Research Institute of Hematology and Blood Transfusion

    Kirov, Kirov Region 610027
    Russian Federation

    Site Not Available

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

    Lipetsk, Lipetsk Region 398007
    Russian Federation

    Site Not Available

  • Herzen Moscow Scientific Research Oncological Institute

    Moscow, Moscow Region 125284
    Russian Federation

    Site Not Available

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

    Moscow, Moscow Region 129110
    Russian Federation

    Site Not Available

  • National Research Center of Hematology of the Ministry of Health

    Moscow, Moscow Region 125167
    Russian Federation

    Site Not Available

  • BaltikMed Clinic

    Kaliningrad, Northwestern Federal District 238022
    Russian Federation

    Site Not Available

  • Vologda Regional Clinical Hospital

    Vologda, Northwestern Federal District 160002
    Russian Federation

    Site Not Available

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

    Novosibirsk, Novosibirsk Region 630051
    Russian Federation

    Site Not Available

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

    Orenburg, Orenburgskaya District 460018
    Russian Federation

    Site Not Available

  • Republican hospital named after V.A.Baranov

    Petrozavodsk, Republic Of Karelia 185019
    Russian Federation

    Site Not Available

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

    Kazan, Republic Tatarstan 420064
    Russian Federation

    Site Not Available

  • City Clinical Hospital No. 31

    St. Petersburg, Saint Petersburg 197110
    Russian Federation

    Site Not Available

  • Leningrad Regional Clinical Hospital

    St. Petersburg, Saint Petersburg 194291
    Russian Federation

    Site Not Available

  • Russian Research Institute of Hematology and Transfusiology

    St. Petersburg, Saint Petersburg 191024
    Russian Federation

    Site Not Available

  • Razumovskiy Saratov State Medical University, University Clinical

    Saratov, Saratov Region 410028
    Russian Federation

    Site Not Available

  • Tomsk Regional Clinical Hospital

    Tomsk, Siberian Federal District 634063
    Russian Federation

    Site Not Available

  • Sverdlovsk Regional Clinical Hospital No. 1

    Yekaterinburg, Sverdlovsk Region 620102
    Russian Federation

    Site Not Available

  • District Clinical Hospital

    Khanty-Mansiysk, Tyumen Region 628012
    Russian Federation

    Site Not Available

  • Surgut Regional Clinical Hospital

    Surgut, Tyumen Region 628408
    Russian Federation

    Site Not Available

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Region 432017
    Russian Federation

    Site Not Available

  • City Clinical Hospital No. 12

    Nizhny Novgorod, Volga Federal District 603003
    Russian Federation

    Site Not Available

  • Clinics of Samara State Medical University

    Samara, Volga Federal District 443079
    Russian Federation

    Site Not Available

  • Clinic Akademicheskaya LLC

    Volgograd, Volgogradskaya District 400001
    Russian Federation

    Site Not Available

  • Alexandro-Mariinsky Regional Clinical Hospital

    Astrakhan, 414056
    Russian Federation

    Site Not Available

  • Rostov Regional Clinical Hospital

    Rostov-on-Don, 344015
    Russian Federation

    Site Not Available

  • Russian Research Institute of Hematology and Transfusiology

    St. Peterburg, 191024
    Russian Federation

    Site Not Available

  • Republican Clinical Hospital named after G.G. Kuvatov

    Ufa, 450005
    Russian Federation

    Site Not Available

  • Republican Hospital No. 1 - National Center of Medicine

    Yakutsk, 677010
    Russian Federation

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.