Clinical trial NCT04721002: Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma (MM)
Keywords: Multiple myeloma (MM)
Relapsed/Refractory (R/R) Multiple myeloma (MM)
t(11
14)
BCL2
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
timeFrame: Up to approximately 2.5 months following last subject last visit
Secondary outcomes:
measure: Percentage of Participants Achieving Stability of t(11;14) Status
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants Achieving Stability of BCL2 Status
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With t(11;14) Status of MM Samples
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With BCL2 Status of MM Samples
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With t(1;14) Status and BCL2 Status
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy
timeFrame: Up to approximately 2.5 months following last subject last visit
measure: Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy
timeFrame: Up to approximately 2.5 months following last subject last visit
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane School of Medicine /ID# 223864
state: Louisiana
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 223865
state: Texas
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 224153
state: Ciudad Autonoma De Buenos Aires
city: Melbourne
country: Australia
facility: Alfred Health /ID# 224386
state: Victoria
city: Salvador
country: Brazil
facility: Hospital São Rafael /ID# 224307
state: Bahia
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 224274
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Clinica Sao Germano /ID# 224239
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Educacao e Pesquisa /ID# 224245
city: Sao Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 224172
state: Alberta
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 226969
state: Grad Zagreb
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 224089
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava /ID# 224090
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 228919
state: Hauts-de-France
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 223702
state: Pays-de-la-Loire
city: Paris
country: France
facility: AP-HP - Hopital Necker /ID# 228062
city: Berlin
country: Germany
facility: Praxis am Volkspark /ID# 224763
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona /ID# 224761
city: Athens
country: Greece
facility: Alexandra General Hospital /ID# 224828
state: Attiki
city: Beaumont
country: Ireland
facility: Beaumont Hospital /ID# 225514
state: Dublin
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 224884
state: Yerushalayim
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 224608
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 224694
city: Oslo
country: Norway
facility: Rikshospitalet OUS HF /ID# 227288
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii /ID# 227039
state: Mazowieckie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038
state: Wielkopolskie
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni /ID# 224574
state: Bucuresti
city: Jeddah
country: Saudi Arabia
facility: Princess Noorah Oncology Center /ID# 224968
city: Ljubljana
country: Slovenia
facility: Univ Medical Ctr Ljubljana /ID# 225408
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 229281
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 224804
city: Leon
country: Spain
facility: Hospital de Leon /ID# 229191
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 229524
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 225617
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 224803
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 227084
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 225515
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: