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

NCT04985643 | Active Not Recruiting

• 1 other identifier: C16058
• Study Type: observational
• Target: 357
• Locations: 1 country
• Sites: 24

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.

Conditions

Multiple Myeloma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM

  According to the International Myeloma Working Group (IMWG), biochemical relapse is diagnosed in participants with relapsing MM based on the following criteria: increase in serum paraprotein by at least 25 percent (%) of nadir (absolute increase should be at least greater than or equal to \[\>=\] 0.5 gram per liter \[g/L\]), increase in urine paraprotein by at least 25% (absolute increase of at least \>=200 milligram per 24 hours \[mg/24 h\]), more than 25% increase in the difference between involved and non-involved free light chains (FLC) with abnormal FLC ratio and absolute increase of at least greater than (\>) 10 milligram per deciliter (mg/dL), increase in plasmacyte infiltration by least \>=10% in participants with non-secretory MM.

  From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)

Secondary Outcomes (26)

• Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM in the Determined Subgroups

  From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)

• Median Time From the Start of First Line Therapy of Participants With MM

  From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)

• Median Time From the Start of Second Line Therapy of Participants With MM to Second Biochemical Relapse of MM

  From the start of the second line therapy until second biochemical relapse (up to approximately 4 years)

• Median Time From the Start of Second Line Therapy of Participants With MM to Second Symptomatic Relapse of MM

  From the start of the second line therapy until second symptomatic relapse (up to approximately 4 years)

• PFS1L: Progression-free Survival (PFS) From the Start of first Line Therapy to the First Biochemical Relapse

  From the start of the first line therapy until first significant biochemical relapse or until the disease progression or death due to any reason whichever occurs first (up to approximately 4 years)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll participants who have a confirmed diagnosis of MM in clinical sites located in the Russian Federation.

You may not qualify if:

• Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.

Sponsors & Collaborators

• Takeda: lead

Study Sites (24)

Altai Regional Clinical Hospital

Barnaul, Altayskiy Kray, 656024, Russia

Location

Kaluga Regional Clinical Hospital

Kaluga, Central Federal District, 248007, Russia

Location

Smolensk Clinical Hospital of Russian Railways-Medicine

Smolensk, Central Federal District, 214025, Russia

Location

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

Khabarovsk, Far Eastern Federal District, 680009, Russia

Location

Kirov Research Institute of Hematology and Blood Transfusion

Kirov, Kirov Oblast, 610027, Russia

Location

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

Lipetsk, Lipetsk Oblast, 398007, Russia

Location

National Research Center of Hematology of the Ministry of Health

Moscow, Moscow Oblast, 125167, Russia

Location

Herzen Moscow Scientific Research Oncological Institute

Moscow, Moscow Oblast, 125284, Russia

Location

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

Moscow, Moscow Oblast, 129110, Russia

Location

BaltikMed Clinic

Kaliningrad, Northwestern Federal District, 238022, Russia

Location

Vologda Regional Clinical Hospital

Vologda, Northwestern Federal District, 160002, Russia

Location

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

Novosibirsk, Novosibirsk Oblast, 630051, Russia

Location

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

Orenburg, Orenburgskaya District, 460018, Russia

Location

Republican hospital named after V.A.Baranov

Petrozavodsk, Republic of Karelia, 185019, Russia

Location

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

Kazan', Republic Tatarstan, 420064, Russia

Location

City Clinical Hospital No. 31

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

Razumovskiy Saratov State Medical University, University Clinical

Saratov, Saratov Oblast, 410028, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, Siberian Federal District, 634063, Russia

Location

District Clinical Hospital

Khanty-Mansiysk, Tyumen Oblast, 628012, Russia

Location

Surgut Regional Clinical Hospital

Surgut, Tyumen Oblast, 628408, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432017, Russia

Location

City Clinical Hospital No. 12

Nizhny Novgorod, Volga Federal District, 603003, Russia

Location

Clinic Akademicheskaya LLC

Volgograd, Volgogradskaya District, 400001, Russia

Location

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, 450005, Russia

Location

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 2, 2021
• Study Start: February 18, 2022
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

RU (24)