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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma (MM)

• Study Type: Observational
• Enrollment (Actual): 514

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: BCL2; Multiple myeloma (MM); Relapsed/Refractory (R/R) Multiple myeloma (MM); t(11; 14)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: H20-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No