Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
- Conditions
- Multiple Myeloma (MM)
- Registration Number
- NCT04721002
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
- 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.
- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells Up to approximately 2.5 months following last subject last visit 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.
Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells Up to approximately 2.5 months following last subject last visit 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Stability of BCL2 Status Up to approximately 2.5 months following last subject last visit Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.
Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages Up to approximately 2.5 months following last subject last visit BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy.
Percentage of Participants Achieving Stability of t(11;14) Status Up to approximately 2.5 months following last subject last visit 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.
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 t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy.
Percentage of Participants With t(11;14) Status of MM Samples Up to approximately 2.5 months following last subject last visit t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy.
Percentage of Participants With t(1;14) Status and BCL2 Status Up to approximately 2.5 months following last subject last visit 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.
Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages Up to approximately 2.5 months following last subject last visit t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy.
Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy Up to approximately 2.5 months following last subject last visit FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples as determined by BM biopsy.
Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy Up to approximately 2.5 months following last subject last visit FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy.
Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy Up to approximately 2.5 months following last subject last visit BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy.
Percentage of Participants With BCL2 Status of MM Samples Up to approximately 2.5 months following last subject last visit BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy.
Trial Locations
- Locations (40)
Klinicki bolnicki centar Zagreb /ID# 226969
ðŸ‡ðŸ‡·Zagreb, Grad Zagreb, Croatia
Fakultni nemocnice Hradec Kralove /ID# 224089
🇨🇿Hradec Kralove, Czechia
AP-HP - Hopital Necker /ID# 228062
🇫🇷Paris, France
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto COI de Educacao e Pesquisa /ID# 224245
🇧🇷Rio de Janeiro, Brazil
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690
🇮🇹Ancona, Italy
Maastricht Universitair Medisch Centrum /ID# 224694
🇳🇱Maastricht, Netherlands
Princess Noorah Oncology Center /ID# 224968
🇸🇦Jeddah, Saudi Arabia
Univ Medical Ctr Ljubljana /ID# 225408
🇸🇮Ljubljana, Slovenia
Beaumont Hospital /ID# 225514
🇮🇪Beaumont, Dublin, Ireland
Hospital Universitario 12 de Octubre /ID# 225617
🇪🇸Madrid, Spain
Alfred Health /ID# 224386
🇦🇺Melbourne, Victoria, Australia
CHRU Lille - Hopital Claude Huriez /ID# 228919
🇫🇷Lille, Hauts-de-France, France
Hospital Italiano de Buenos Aires /ID# 224153
🇦🇷Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Institutul Clinic Fundeni /ID# 224574
🇷🇴Bucharest, Bucuresti, Romania
Hospital de Leon /ID# 229191
🇪🇸Leon, Spain
Fakultni nemocnice Ostrava /ID# 224090
🇨🇿Ostrava, Czechia
Hadassah Medical Center-Hebrew University /ID# 224884
🇮🇱Jerusalem, Yerushalayim, Israel
Rikshospitalet OUS HF /ID# 227288
🇳🇴Oslo, Norway
Taichung Veterans General Hospital /ID# 227084
🇨🇳Taichung, Taiwan
CHU de Nantes, Hotel Dieu -HME /ID# 223702
🇫🇷Nantes, Pays-de-la-Loire, France
Hospital Clinic de Barcelona /ID# 224804
🇪🇸Barcelona, Spain
Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305
🇧🇷Sao Paulo, Brazil
Hospital de Clinicas de Porto Alegre /ID# 224274
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clinica Sao Germano /ID# 224239
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749
🇧🇷Sao Paulo, Brazil
ASST Grande Ospedale Metropolitano Niguarda /ID# 224608
🇮🇹Milano, Italy
Instytut Hematologii i Transfuzjologii /ID# 227039
🇵🇱Warszawa, Mazowieckie, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038
🇵🇱Poznan, Wielkopolskie, Poland
Cross Cancer Institute /ID# 224172
🇨🇦Edmonton, Alberta, Canada
Praxis am Volkspark /ID# 224763
🇩🇪Berlin, Germany
Alexandra General Hospital /ID# 224828
🇬🇷Athens, Attiki, Greece
Hospital Universitario de Salamanca /ID# 224803
🇪🇸Salamanca, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 229524
🇪🇸Madrid, Spain
Bagcilar Medipol Mega Universite Hastanesi /ID# 225515
🇹🇷Istanbul, Turkey
Asklepios Klinik Altona /ID# 224761
🇩🇪Hamburg, Germany
Hospital Universitario Germans Trias i Pujol /ID# 229281
🇪🇸Badalona, Barcelona, Spain
Hospital São Rafael /ID# 224307
🇧🇷Salvador, Bahia, Brazil
University of Texas Southwestern Medical Center /ID# 223865
🇺🇸Dallas, Texas, United States
Tulane School of Medicine /ID# 223864
🇺🇸New Orleans, Louisiana, United States