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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Stability of t(11;14) Status | Stability of t(11;14) status across intra-patient longitudinal bone marrow (BM) samples (changed vs not changed) collected at initial diagnosis and across lines of therapies. | Up to approximately 2.5 months following last subject last visit |
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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.
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Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane School of Medicine /ID# 223864 | New Orleans | Louisiana | 70112 | United States | ||
| University of Texas Southwestern Medical Center /ID# 223865 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40829119 | Derived | 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. |
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Bone marrow aspirate and peripheral blood
| Percentage of Participants Achieving Stability of BCL2 Status |
Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies. |
| 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 | t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy | BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With t(11;14) Status of MM Samples | t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With BCL2 Status of MM Samples | BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages | t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages | BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With t(1;14) Status and BCL2 Status | t(11;14) and BCL2 status (Positive and BCL2high, Negative and BCL2high, Positive and BCL2low, Negative and BCL2low) of the earliest MM samples collected, at initial diagnosis or across lines of therapies, by FISH and qPCR analyses of bone marrow plasma cells, respectively. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy | FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy | FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy. | Up to approximately 2.5 months following last subject last visit |
| Dallas |
| Texas |
| 75390-7208 |
| United States |
| Hospital Italiano de Buenos Aires /ID# 224153 | Ciudad Autonoma Buenos Aires | Buenos Aires F.D. | 1199 | Argentina |
| Alfred Health /ID# 224386 | Melbourne | Victoria | 3004 | Australia |
| Hospital São Rafael /ID# 224307 | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital de Clinicas de Porto Alegre /ID# 224274 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Clinica Sao Germano /ID# 224239 | São Paulo | São Paulo | 04537-080 | Brazil |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303 | São Paulo | São Paulo | 05652-900 | Brazil |
| Instituto COI de Educacao e Pesquisa /ID# 224245 | Rio de Janeiro | 22793-080 | Brazil |
| Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305 | São Paulo | 01323-001 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749 | São Paulo | 05403-000 | Brazil |
| Cross Cancer Institute /ID# 224172 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Klinicki bolnicki centar Zagreb /ID# 226969 | Zagreb | City of Zagreb | 10000 | Croatia |
| Fakultni nemocnice Hradec Kralove /ID# 224089 | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Ostrava /ID# 224090 | Ostrava | 708 52 | Czechia |
| CHRU Lille - Hopital Claude Huriez /ID# 228919 | Lille | Hauts-de-France | 59037 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 223702 | Nantes | Pays de la Loire Region | 44000 | France |
| AP-HP - Hopital Necker /ID# 228062 | Paris | 75015 | France |
| Praxis am Volkspark /ID# 224763 | Berlin | 10715 | Germany |
| Asklepios Klinik Altona /ID# 224761 | Hamburg | 22763 | Germany |
| Alexandra General Hospital /ID# 224828 | Athens | Attica | 11528 | Greece |
| Beaumont Hospital /ID# 225514 | Beaumont | Dublin | D09 XR63 | Ireland |
| Hadassah Medical Center-Hebrew University /ID# 224884 | Jerusalem | Jerusalem | 91120 | Israel |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690 | Ancona | 60126 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 224608 | Milan | 20162 | Italy |
| Maastricht Universitair Medisch Centrum /ID# 224694 | Maastricht | 6229 HX | Netherlands |
| Rikshospitalet OUS HF /ID# 227288 | Oslo | 0450 | Norway |
| Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038 | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
| Instytut Hematologii i Transfuzjologii /ID# 227039 | Warsaw | Masovian Voivodeship | 02-776 | Poland |
| Institutul Clinic Fundeni /ID# 224574 | Bucharest | Bucharest | 022328 | Romania |
| Princess Noorah Oncology Center /ID# 224968 | Jeddah | 22384 | Saudi Arabia |
| Univ Medical Ctr Ljubljana /ID# 225408 | Ljubljana | 1000 | Slovenia |
| Hospital Universitario Germans Trias i Pujol /ID# 229281 | Badalona | Barcelona | 08916 | Spain |
| Hospital Clinic de Barcelona /ID# 224804 | Barcelona | 08036 | Spain |
| Hospital de Leon /ID# 229191 | León | 24071 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 229524 | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre /ID# 225617 | Madrid | 28041 | Spain |
| Hospital Universitario de Salamanca /ID# 224803 | Salamanca | 37711 | Spain |
| Taichung Veterans General Hospital /ID# 227084 | Taichung | 40705 | Taiwan |
| Bagcilar Medipol Mega Universite Hastanesi /ID# 225515 | Istanbul | 34214 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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