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

Multiple Myeloma (MM) Clinical Trial

— MEDICI  

Official title:

MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721002
• Other study ID #: H20-126
• Status: Completed
• Start date: July 7, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma (MM)
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires /ID# 224153	Ciudad Autonoma Buenos Aires	Ciudad Autonoma De Buenos Aires
Australia	Alfred Health /ID# 224386	Melbourne	Victoria
Brazil	Hospital de Clinicas de Porto Alegre /ID# 224274	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto COI de Educacao e Pesquisa /ID# 224245	Rio de Janeiro
Brazil	Hospital São Rafael /ID# 224307	Salvador	Bahia
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749	Sao Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305	Sao Paulo
Brazil	Clinica Sao Germano /ID# 224239	São Paulo	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303	São Paulo	Sao Paulo
Canada	Cross Cancer Institute /ID# 224172	Edmonton	Alberta
Croatia	Klinicki bolnicki centar Zagreb /ID# 226969	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Hradec Kralove /ID# 224089	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava /ID# 224090	Ostrava
France	CHRU Lille - Hopital Claude Huriez /ID# 228919	Lille	Hauts-de-France
France	CHU de Nantes, Hotel Dieu -HME /ID# 223702	Nantes	Pays-de-la-Loire
France	AP-HP - Hopital Necker /ID# 228062	Paris
Germany	Praxis am Volkspark /ID# 224763	Berlin
Germany	Asklepios Klinik Altona /ID# 224761	Hamburg
Greece	Alexandra General Hospital /ID# 224828	Athens	Attiki
Ireland	Beaumont Hospital /ID# 225514	Beaumont	Dublin
Israel	Hadassah Medical Center-Hebrew University /ID# 224884	Jerusalem	Yerushalayim
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690	Ancona
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 224608	Milano
Netherlands	Maastricht Universitair Medisch Centrum /ID# 224694	Maastricht
Norway	Rikshospitalet OUS HF /ID# 227288	Oslo
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038	Poznan	Wielkopolskie
Poland	Instytut Hematologii i Transfuzjologii /ID# 227039	Warszawa	Mazowieckie
Romania	Institutul Clinic Fundeni /ID# 224574	Bucharest	Bucuresti
Saudi Arabia	Princess Noorah Oncology Center /ID# 224968	Jeddah
Slovenia	Univ Medical Ctr Ljubljana /ID# 225408	Ljubljana
Spain	Hospital Universitario Germans Trias i Pujol /ID# 229281	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona /ID# 224804	Barcelona
Spain	Hospital de Leon /ID# 229191	Leon
Spain	Hospital Universitario 12 de Octubre /ID# 225617	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 229524	Madrid
Spain	Hospital Universitario de Salamanca /ID# 224803	Salamanca
Taiwan	Taichung Veterans General Hospital /ID# 227084	Taichung
Turkey	Bagcilar Medipol Mega Universite Hastanesi /ID# 225515	Istanbul
United States	University of Texas Southwestern Medical Center /ID# 223865	Dallas	Texas
United States	Tulane School of Medicine /ID# 223864	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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