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

NCT04721002 | Completed

• 1 other identifier: H20-126
• Study Type: observational
• Target: 514
• Locations: 22 countries
• Sites: 40

Brief Summary

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.

Conditions

Multiple Myeloma (MM)

Keywords

Multiple myeloma (MM); Relapsed/Refractory (R/R) Multiple myeloma (MM); t(11; 14); BCL2

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells

  t(11;14) status (positive or negative) of the earliest multiple myeloma (MM) sample collected at initial diagnosis or across lines of therapies, by FISH analysis of bone marrow plasma cells is evaluated.

  Up to approximately 2.5 months following last subject last visit

• Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells

  BCL2 status (BCL2 high or not) of the earliest MM sample collected, either at initial diagnosis or across lines of therapies, by qPCR analysis of bone marrow plasma cells is evaluated.

  Up to approximately 2.5 months following last subject last visit

Secondary Outcomes (11)

• Percentage of Participants Achieving Stability of t(11;14) Status

  Up to approximately 2.5 months following last subject last visit

• Percentage of Participants Achieving Stability of BCL2 Status

  Up to approximately 2.5 months following last subject last visit

• Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy

  Up to approximately 2.5 months following last subject last visit

• Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy

  Up to approximately 2.5 months following last subject last visit

• Percentage of Participants With t(11;14) Status of MM Samples

  Up to approximately 2.5 months following last subject last visit

Study Arms (1)

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.

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

Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (40)

Tulane School of Medicine /ID# 223864

New Orleans, Louisiana, 70112, United States

Location

University of Texas Southwestern Medical Center /ID# 223865

Dallas, Texas, 75390-7208, United States

Location

Hospital Italiano de Buenos Aires /ID# 224153

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199, Argentina

Location

Alfred Health /ID# 224386

Melbourne, Victoria, 3004, Australia

Location

Hospital São Rafael /ID# 224307

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 224274

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Clinica Sao Germano /ID# 224239

São Paulo, São Paulo, 04537-080, Brazil

Location

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303

São Paulo, São Paulo, 05652-900, Brazil

Location

Instituto COI de Educacao e Pesquisa /ID# 224245

Rio de Janeiro, 22793-080, Brazil

Location

Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305

São Paulo, 01323-001, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

Cross Cancer Institute /ID# 224172

Edmonton, Alberta, T6G 1Z2, Canada

Location

Klinicki bolnicki centar Zagreb /ID# 226969

Zagreb, City of Zagreb, 10000, Croatia

Location

Fakultni nemocnice Hradec Kralove /ID# 224089

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Ostrava /ID# 224090

Ostrava, 708 52, Czechia

Location

CHRU Lille - Hopital Claude Huriez /ID# 228919

Lille, Hauts-de-France, 59037, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

AP-HP - Hopital Necker /ID# 228062

Paris, 75015, France

Location

Praxis am Volkspark /ID# 224763

Berlin, 10715, Germany

Location

Asklepios Klinik Altona /ID# 224761

Hamburg, 22763, Germany

Location

Alexandra General Hospital /ID# 224828

Athens, Attica, 11528, Greece

Location

Beaumont Hospital /ID# 225514

Beaumont, Dublin, D09 XR63, Ireland

Location

Hadassah Medical Center-Hebrew University /ID# 224884

Jerusalem, Jerusalem, 91120, Israel

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

Ancona, 60126, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

Milan, 20162, Italy

Location

Maastricht Universitair Medisch Centrum /ID# 224694

Maastricht, 6229 HX, Netherlands

Location

Rikshospitalet OUS HF /ID# 227288

Oslo, 0450, Norway

Location

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

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

Instytut Hematologii i Transfuzjologii /ID# 227039

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

Institutul Clinic Fundeni /ID# 224574

Bucharest, București, 022328, Romania

Location

Princess Noorah Oncology Center /ID# 224968

Jeddah, 22384, Saudi Arabia

Location

Univ Medical Ctr Ljubljana /ID# 225408

Ljubljana, 1000, Slovenia

Location

Hospital Universitario Germans Trias i Pujol /ID# 229281

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic de Barcelona /ID# 224804

Barcelona, 08036, Spain

Location

Hospital de Leon /ID# 229191

León, 24071, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 229524

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre /ID# 225617

Madrid, 28041, Spain

Location

Hospital Universitario de Salamanca /ID# 224803

Salamanca, 37711, Spain

Location

Taichung Veterans General Hospital /ID# 227084

Taichung, 40705, Taiwan

Location

Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (1)

• Spencer A, Gavriatopoulou M, Coriu D, Lysen A, Gutierrez NC, Escalante F, Eugenia Fantl DB, Hajek R, Seguro F, Kaur G, Bittencourt R, Kinda SB, Chu MP, Safah H, Martinez-Lopez J, de Queiroz Crusoe E, Cordeiro de Farias DL, Offidani M, Askari E, Sevindik OG, Maisnar V, Teng CL, Hughes O, Taylor R, Lehn K, Feng D, Thiebaut-Millot R, Li X, Murray L, Jung P, Rossi EL, Kongpachith S, Nichol A, Ross JA, Hader C. Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis. Blood Adv. 2025 Nov 25;9(22):5814-5827. doi: 10.1182/bloodadvances.2025017214.

  PMID: 40829119 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow aspirate and peripheral blood

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 22, 2021
• Study Start: July 7, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (2); GR (1); SL (1); BR (7); NL (1); PL (2); CZ (2); CA (1); FR (3); CR (1); DE (2); IE (1); IL (1); NO (1); AR (1); TW (1); TU (1); AU (1); ES (6); SA (1); RO (1); IT (2)