Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)

NCT ID: NCT04721002

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2023-09-30

Brief Summary

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Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.

Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.

Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

Detailed Description

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Conditions

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Multiple Myeloma (MM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants With Multiple Myeloma

Participants with newly diagnosed and relapsed/refractory multiple myeloma will receive standard of care. Bone marrow and blood samples will be collected.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.

Exclusion Criteria

\- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Tulane School of Medicine /ID# 223864

New Orleans, Louisiana, United States

Site Status

University of Texas Southwestern Medical Center /ID# 223865

Dallas, Texas, United States

Site Status

Hospital Italiano de Buenos Aires /ID# 224153

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Alfred Health /ID# 224386

Melbourne, Victoria, Australia

Site Status

Hospital São Rafael /ID# 224307

Salvador, Estado de Bahia, Brazil

Site Status

Hospital de Clinicas de Porto Alegre /ID# 224274

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica Sao Germano /ID# 224239

São Paulo, São Paulo, Brazil

Site Status

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303

São Paulo, São Paulo, Brazil

Site Status

Instituto COI de Educacao e Pesquisa /ID# 224245

Rio de Janeiro, , Brazil

Site Status

Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305

São Paulo, , Brazil

Site Status

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749

São Paulo, , Brazil

Site Status

Cross Cancer Institute /ID# 224172

Edmonton, Alberta, Canada

Site Status

Klinicki bolnicki centar Zagreb /ID# 226969

Zagreb, City of Zagreb, Croatia

Site Status

Fakultni nemocnice Hradec Kralove /ID# 224089

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Ostrava /ID# 224090

Ostrava, , Czechia

Site Status

CHRU Lille - Hopital Claude Huriez /ID# 228919

Lille, Hauts-de-France, France

Site Status

CHU de Nantes, Hotel Dieu -HME /ID# 223702

Nantes, Pays de la Loire Region, France

Site Status

AP-HP - Hopital Necker /ID# 228062

Paris, , France

Site Status

Praxis am Volkspark /ID# 224763

Berlin, , Germany

Site Status

Asklepios Klinik Altona /ID# 224761

Hamburg, , Germany

Site Status

Alexandra General Hospital /ID# 224828

Athens, Attica, Greece

Site Status

Beaumont Hospital /ID# 225514

Beaumont, Dublin, Ireland

Site Status

Hadassah Medical Center-Hebrew University /ID# 224884

Jerusalem, Jerusalem, Israel

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

Ancona, , Italy

Site Status

ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

Milan, , Italy

Site Status

Maastricht Universitair Medisch Centrum /ID# 224694

Maastricht, , Netherlands

Site Status

Rikshospitalet OUS HF /ID# 227288

Oslo, , Norway

Site Status

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038

Poznan, Greater Poland Voivodeship, Poland

Site Status

Instytut Hematologii i Transfuzjologii /ID# 227039

Warsaw, Masovian Voivodeship, Poland

Site Status

Institutul Clinic Fundeni /ID# 224574

Bucharest, București, Romania

Site Status

Princess Noorah Oncology Center /ID# 224968

Jeddah, , Saudi Arabia

Site Status

Univ Medical Ctr Ljubljana /ID# 225408

Ljubljana, , Slovenia

Site Status

Hospital Universitario Germans Trias i Pujol /ID# 229281

Badalona, Barcelona, Spain

Site Status

Hospital Clinic de Barcelona /ID# 224804

Barcelona, , Spain

Site Status

Hospital de Leon /ID# 229191

León, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz /ID# 229524

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre /ID# 225617

Madrid, , Spain

Site Status

Hospital Universitario de Salamanca /ID# 224803

Salamanca, , Spain

Site Status

Taichung Veterans General Hospital /ID# 227084

Taichung, , Taiwan

Site Status

Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Brazil Canada Croatia Czechia France Germany Greece Ireland Israel Italy Netherlands Norway Poland Romania Saudi Arabia Slovenia Spain Taiwan Turkey (Türkiye)

Other Identifiers

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H20-126

Identifier Type: -

Identifier Source: org_study_id

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