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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04985643
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Altai Regional Clinical Hospital, Barnaul, Altay Region, Russian Federation

Status

Recruiting

Address

Altai Regional Clinical Hospital

Barnaul, Altay Region, 656024

Site Contact

Site Contact

otmorsckaya@yandex.ru

89132134574

Bryansk Regional Hospital No. 1, Bryansk, Bryansk Region, Russian Federation

Status

Active, not recruiting

Address

Bryansk Regional Hospital No. 1

Bryansk, Bryansk Region, 241033

Kaluga Regional Clinical Hospital, Kaluga, Central Federal District, Russian Federation

Status

Recruiting

Address

Kaluga Regional Clinical Hospital

Kaluga, Central Federal District, 248007

Site Contact

Site Contact

elenaborisenkova@yandex.ru

89107058728

Smolensk, Central Federal District, Russian Federation

Status

Recruiting

Address

Smolensk Clinical Hospital of Russian Railways-Medicine

Smolensk, Central Federal District, 214025

Site Contact

Site Contact

Gemdocmaria@mail.ru

89107868329

Khabarovsk, Far Eastern Federal District, Russian Federation

Status

Recruiting

Address

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

Khabarovsk, Far Eastern Federal District, 680009

Site Contact

Site Contact

khhemnatali@mail.ru

8 909 855 86 67

Lipetsk, Lipetsk Region, Russian Federation

Status

Recruiting

Address

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

Lipetsk, Lipetsk Region, 398007

Site Contact

Site Contact

kavmed78@yandex.ru

8 903 867 37 89

Moscow, Moscow Region, Russian Federation

Status

Recruiting

Address

National Research Center of Hematology of the Ministry of Health

Moscow, Moscow Region, 125167

Site Contact

Site Contact

mendeleeva.l@blood.ru

89036635300

Moscow, Moscow Region, Russian Federation

Status

Recruiting

Address

Herzen Moscow Scientific Research Oncological Institute

Moscow, Moscow Region, 125284

Site Contact

Site Contact

s.semochkin@gmail.com

89161541233

Moscow, Moscow Region, Russian Federation

Status

Recruiting

Address

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

Moscow, Moscow Region, 129110

Site Contact

Site Contact

mi_69@inbox.ru

89057064068

BaltikMed Clinic, Kaliningrad, Northwestern Federal District, Russian Federation

Status

Recruiting

Address

BaltikMed Clinic

Kaliningrad, Northwestern Federal District, 238022

Site Contact

Site Contact

nat-bulieva@yandex.ru

89114933952

Vologda Regional Clinical Hospital, Vologda, Northwestern Federal District, Russian Federation

Status

Recruiting

Address

Vologda Regional Clinical Hospital

Vologda, Northwestern Federal District, 160002

Site Contact

Site Contact

fmv-74@mail.ru

89212339156

Novosibirsk, Novosibirsk Region, Russian Federation

Status

Recruiting

Address

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

Novosibirsk, Novosibirsk Region, 630051

Site Contact

Site Contact

postatgem@mail.ru

89139127759

Petrozavodsk, Republic Of Karelia, Russian Federation

Status

Recruiting

Address

Republican hospital named after V.A.Baranov

Petrozavodsk, Republic Of Karelia, 185019

Site Contact

Site Contact

veronikalaguta@mail.ru

89535350902

Kazan, Republic Tatarstan, Russian Federation

Status

Recruiting

Address

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

Kazan, Republic Tatarstan, 420064

Site Contact

Site Contact

kunstma@mail.ru

89047607920

St. Petersburg, Saint Petersburg, Russian Federation

Status

Active, not recruiting

Address

Russian Research Institute of Hematology and Transfusiology

St. Petersburg, Saint Petersburg, 191024

Leningrad Regional Clinical Hospital, St. Petersburg, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Leningrad Regional Clinical Hospital

St. Petersburg, Saint Petersburg, 194291

Site Contact

Site Contact

morela@mail.ru

89031521550

City Clinical Hospital No. 31, St. Petersburg, Saint Petersburg, Russian Federation

Status

Recruiting

Address

City Clinical Hospital No. 31

St. Petersburg, Saint Petersburg, 197110

Site Contact

Site Contact

medv-05@mail.ru

89219123309

Tomsk Regional Clinical Hospital, Tomsk, Siberian Federal District, Russian Federation

Status

Recruiting

Address

Tomsk Regional Clinical Hospital

Tomsk, Siberian Federal District, 634063

Site Contact

Site Contact

yuliyakolbanova@yandex.ru

8 903 952 53 58

Yekaterinburg, Sverdlovsk Region, Russian Federation

Status

Active, not recruiting

Address

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, Sverdlovsk Region, 620102

District Clinical Hospital, Khanty-Mansiysk, Tyumen Region, Russian Federation

Status

Active, not recruiting

Address

District Clinical Hospital

Khanty-Mansiysk, Tyumen Region, 628012

Surgut Regional Clinical Hospital, Surgut, Tyumen Region, Russian Federation

Status

Recruiting

Address

Surgut Regional Clinical Hospital

Surgut, Tyumen Region, 628408

Site Contact

Site Contact

elena-zinina@yandex.ru

79222536795

Ulyanovsk Regional Clinical Hospital, Ulyanovsk, Ulyanovsk Region, Russian Federation

Status

Recruiting

Address

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Region, 432017

Site Contact

Site Contact

natalya.es@mail.ru

8 927 820 01 26

City Clinical Hospital No. 12, Nizhny Novgorod, Volga Federal District, Russian Federation

Status

Recruiting

Address

City Clinical Hospital No. 12

Nizhny Novgorod, Volga Federal District, 603003

Site Contact

Site Contact

alb.shishkina73@gmail.com

89103920936

Samara, Volga Federal District, Russian Federation

Status

Active, not recruiting

Address

Clinics of Samara State Medical University

Samara, Volga Federal District, 443079

Ufa, Russian Federation

Status

Recruiting

Address

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, , 450005

Site Contact

Site Contact

ai_shamsutdinova@mail.ru

89177720570