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

Study Purpose

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.

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:

  • - 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.

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.

NCT04721002
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.

AbbVie
Principal Investigator

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

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

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

Industry
Overall Status Recruiting
Countries Argentina, Australia, Brazil, Canada, Croatia, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Romania, Saudi Arabia, Slovenia, Spain, Taiwan, Turkey, United States
Conditions

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

Multiple Myeloma (MM)
Arms & Interventions

Arms

: 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.

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.

Tulane School of Medicine /ID# 223864, New Orleans, Louisiana

Status

Recruiting

Address

Tulane School of Medicine /ID# 223864

New Orleans, Louisiana, 70112

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center /ID# 223865

Dallas, Texas, 75390-7208

International Sites

Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Italiano de Buenos Aires /ID# 224153

Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, 1199

Alfred Health /ID# 224386, Melbourne, Victoria, Australia

Status

Recruiting

Address

Alfred Health /ID# 224386

Melbourne, Victoria, 3004

Hospital São Rafael /ID# 224307, Salvador, Bahia, Brazil

Status

Recruiting

Address

Hospital São Rafael /ID# 224307

Salvador, Bahia, 41253-190

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

Hospital de Clinicas de Porto Alegre /ID# 224274

Porto Alegre, Rio Grande Do Sul, 90035-903

Clinica Sao Germano /ID# 224239, São Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Clinica Sao Germano /ID# 224239

São Paulo, Sao Paulo, 04537-080

São Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303

São Paulo, Sao Paulo, 05652-900

Rio de Janeiro, Brazil

Status

Recruiting

Address

Instituto COI de Educacao e Pesquisa /ID# 224245

Rio de Janeiro, , 22793-080

Sao Paulo, Brazil

Status

Recruiting

Address

Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305

Sao Paulo, , 01323-001

Sao Paulo, Brazil

Status

Recruiting

Address

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

Sao Paulo, , 05403-000

Cross Cancer Institute /ID# 224172, Edmonton, Alberta, Canada

Status

Recruiting

Address

Cross Cancer Institute /ID# 224172

Edmonton, Alberta, T6G 1Z2

Zagreb, Grad Zagreb, Croatia

Status

Completed

Address

Klinicki bolnicki centar Zagreb /ID# 226969

Zagreb, Grad Zagreb, 10000

Hradec Kralove, Czechia

Status

Completed

Address

Fakultni nemocnice Hradec Kralove /ID# 224089

Hradec Kralove, , 500 05

Fakultni nemocnice Ostrava /ID# 224090, Ostrava, Czechia

Status

Recruiting

Address

Fakultni nemocnice Ostrava /ID# 224090

Ostrava, , 708 52

Lille, Hauts-de-France, France

Status

Completed

Address

CHRU Lille - Hopital Claude Huriez /ID# 228919

Lille, Hauts-de-France, 59037

Nantes, Pays-de-la-Loire, France

Status

Completed

Address

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

Nantes, Pays-de-la-Loire, 44000

AP-HP - Hopital Necker /ID# 228062, Paris, France

Status

Completed

Address

AP-HP - Hopital Necker /ID# 228062

Paris, , 75015

Praxis am Volkspark /ID# 224763, Berlin, Germany

Status

Completed

Address

Praxis am Volkspark /ID# 224763

Berlin, , 10715

Asklepios Klinik Altona /ID# 224761, Hamburg, Germany

Status

Completed

Address

Asklepios Klinik Altona /ID# 224761

Hamburg, , 22763

Alexandra General Hospital /ID# 224828, Athens, Attiki, Greece

Status

Recruiting

Address

Alexandra General Hospital /ID# 224828

Athens, Attiki, 11528

Beaumont Hospital /ID# 225514, Beaumont, Dublin, Ireland

Status

Completed

Address

Beaumont Hospital /ID# 225514

Beaumont, Dublin, D09 XR63

Jerusalem, Yerushalayim, Israel

Status

Completed

Address

Hadassah Medical Center-Hebrew University /ID# 224884

Jerusalem, Yerushalayim, 91120

Ancona, Italy

Status

Completed

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

Ancona, , 60126

Milano, Italy

Status

Completed

Address

ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

Milano, , 20162

Maastricht, Netherlands

Status

Completed

Address

Maastricht Universitair Medisch Centrum /ID# 224694

Maastricht, , 6229 HX

Rikshospitalet OUS HF /ID# 227288, Oslo, Norway

Status

Completed

Address

Rikshospitalet OUS HF /ID# 227288

Oslo, , 0450

Warszawa, Mazowieckie, Poland

Status

Completed

Address

Instytut Hematologii i Transfuzjologii /ID# 227039

Warszawa, Mazowieckie, 02-776

Poznan, Wielkopolskie, Poland

Status

Completed

Address

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

Poznan, Wielkopolskie, 60-569

Institutul Clinic Fundeni /ID# 224574, Bucharest, Bucuresti, Romania

Status

Completed

Address

Institutul Clinic Fundeni /ID# 224574

Bucharest, Bucuresti, 022328

Jeddah, Saudi Arabia

Status

Completed

Address

Princess Noorah Oncology Center /ID# 224968

Jeddah, , 22384

Univ Medical Ctr Ljubljana /ID# 225408, Ljubljana, Slovenia

Status

Completed

Address

Univ Medical Ctr Ljubljana /ID# 225408

Ljubljana, , 1000

Badalona, Barcelona, Spain

Status

Completed

Address

Hospital Universitario Germans Trias i Pujol /ID# 229281

Badalona, Barcelona, 08916

Hospital Clinic de Barcelona /ID# 224804, Barcelona, Spain

Status

Completed

Address

Hospital Clinic de Barcelona /ID# 224804

Barcelona, , 08036

Hospital de Leon /ID# 229191, Leon, Spain

Status

Completed

Address

Hospital de Leon /ID# 229191

Leon, , 24071

Madrid, Spain

Status

Completed

Address

Hospital Universitario Fundacion Jimenez Diaz /ID# 229524

Madrid, , 28040

Madrid, Spain

Status

Completed

Address

Hospital Universitario 12 de Octubre /ID# 225617

Madrid, , 28041

Salamanca, Spain

Status

Completed

Address

Hospital Universitario de Salamanca /ID# 224803

Salamanca, , 37711

Taichung, Taiwan

Status

Completed

Address

Taichung Veterans General Hospital /ID# 227084

Taichung, , 40705

Istanbul, Turkey

Status

Completed

Address

Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

Istanbul, , 34214