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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04721002

Collaborator

(none)

500

Enrollment

Locations

17.8

Anticipated Duration (Months)

12.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma (MM)

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 7, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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.
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 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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tulane School of Medicine /ID# 223864	New Orleans	Louisiana	United States	70112
2	University of Texas Southwestern Medical Center /ID# 223865	Dallas	Texas	United States	75390-7208
3	Hospital Italiano de Buenos Aires /ID# 224153	Ciudad Autonoma Buenos Aires	Ciuadad Autonoma De Buenos Aires	Argentina	1199
4	Alfred Health /ID# 224386	Melbourne	Victoria	Australia	3004
5	Hospital São Rafael /ID# 224307	Salvador	Bahia	Brazil	41253-190
6	Hospital de Clinicas de Porto Alegre /ID# 224274	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
7	Clinica Sao Germano /ID# 224239	São Paulo	Sao Paulo	Brazil	04537-080
8	Sociedade Beneficente Israelita Hospital Albert Einstein /ID# 224303	São Paulo	Sao Paulo	Brazil	05652-900
9	Instituto COI de Educacao e Pesquisa /ID# 224245	Rio de Janeiro		Brazil	22793-080
10	Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305	Sao Paulo		Brazil	01323-001
11	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749	Sao Paulo		Brazil	05403-000
12	Cross Cancer Institute /ID# 224172	Edmonton	Alberta	Canada	T6G 1Z2
13	Klinicki bolnicki centar Zagreb /ID# 226969	Zagreb	Grad Zagreb	Croatia	10000
14	Fakultni nemocnice Hradec Kralove /ID# 224089	Hradec Kralove		Czechia	500 05
15	Fakultni nemocnice Ostrava /ID# 224090	Ostrava		Czechia	708 52
16	CHRU Lille - Hopital Claude Huriez /ID# 228919	Lille	Hauts-de-France	France	59037
17	CHU de Nantes, Hotel Dieu -HME /ID# 223702	Nantes	Pays-de-la-Loire	France	44000
18	AP-HP - Hopital Necker /ID# 228062	Paris		France	75015
19	Praxis am Volkspark /ID# 224763	Berlin		Germany	10715
20	Asklepios Klinik Altona /ID# 224761	Hamburg		Germany	22763
21	Alexandra General Hospital /ID# 224828	Athens	Attiki	Greece	11528
22	Beaumont Hospital /ID# 225514	Beaumont	Dublin	Ireland	D09 XR63
23	Hadassah Medical Center-Hebrew University /ID# 224884	Jerusalem		Israel	91120
24	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690	Ancona		Italy	60126
25	ASST Grande Ospedale Metropolitano Niguarda /ID# 224608	Milano		Italy	20162
26	Maastricht Universitair Medisch Centrum /ID# 224694	Maastricht		Netherlands	6229 HX
27	Rikshospitalet OUS HF /ID# 227288	Oslo		Norway	0450
28	Instytut Hematologii i Transfuzjologii /ID# 227039	Warszawa	Mazowieckie	Poland	02-776
29	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Mar /ID# 227038	Poznan	Wielkopolskie	Poland	60-569
30	Institutul Clinic Fundeni /ID# 224574	Sector 2	Bucuresti	Romania	022328
31	Princess Noorah Oncology Center /ID# 224968	Jeddah		Saudi Arabia	22384
32	Univ Medical Ctr Ljubljana /ID# 225408	Ljubljana		Slovenia	1000
33	Hospital Universitario Germans Trias i Pujol /ID# 229281	Badalona	Barcelona	Spain	08916
34	Hospital Clinic de Barcelona /ID# 224804	Barcelona		Spain	08036
35	Hospital de Leon /ID# 229191	Leon		Spain	24071
36	Hospital Universitario Fundacion Jimenez Diaz /ID# 229524	Madrid		Spain	28040
37	Hospital Universitario 12 de Octubre /ID# 225617	Madrid		Spain	28041
38	Hospital Universitario de Salamanca /ID# 224803	Salamanca		Spain	37711
39	Taichung Veterans General Hospital /ID# 227084	Taichung		Taiwan	40705
40	Bagcilar Medipol Mega Universite Hastanesi /ID# 225515	Istanbul		Turkey	34214