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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04721002




Registration number
NCT04721002
Ethics application status
Date submitted
21/01/2021
Date registered
22/01/2021
Date last updated
18/10/2023

Titles & IDs
Public title
Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
Scientific title
MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types
Secondary ID [1] 0 0
H20-126
Universal Trial Number (UTN)
Trial acronym
MEDICI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
Timepoint [1] 0 0
Up to approximately 2.5 months following last subject last visit
Primary outcome [2] 0 0
Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
Timepoint [2] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [1] 0 0
Percentage of Participants Achieving Stability of t(11;14) Status
Timepoint [1] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [2] 0 0
Percentage of Participants Achieving Stability of BCL2 Status
Timepoint [2] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [3] 0 0
Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy
Timepoint [3] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [4] 0 0
Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy
Timepoint [4] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [5] 0 0
Percentage of Participants With t(11;14) Status of MM Samples
Timepoint [5] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [6] 0 0
Percentage of Participants With BCL2 Status of MM Samples
Timepoint [6] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [7] 0 0
Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages
Timepoint [7] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [8] 0 0
Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages
Timepoint [8] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [9] 0 0
Percentage of Participants With t(1;14) Status and BCL2 Status
Timepoint [9] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [10] 0 0
Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy
Timepoint [10] 0 0
Up to approximately 2.5 months following last subject last visit
Secondary outcome [11] 0 0
Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy
Timepoint [11] 0 0
Up to approximately 2.5 months following last subject last visit

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at
confirmation of relapse.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
514
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health /ID# 224386 - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma De Buenos Aires
Country [4] 0 0
Brazil
State/province [4] 0 0
Bahia
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio Grande Do Sul
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Croatia
State/province [9] 0 0
Grad Zagreb
Country [10] 0 0
Czechia
State/province [10] 0 0
Hradec Kralove
Country [11] 0 0
Czechia
State/province [11] 0 0
Ostrava
Country [12] 0 0
France
State/province [12] 0 0
Hauts-de-France
Country [13] 0 0
France
State/province [13] 0 0
Pays-de-la-Loire
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Greece
State/province [17] 0 0
Attiki
Country [18] 0 0
Ireland
State/province [18] 0 0
Dublin
Country [19] 0 0
Israel
State/province [19] 0 0
Yerushalayim
Country [20] 0 0
Italy
State/province [20] 0 0
Ancona
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Netherlands
State/province [22] 0 0
Maastricht
Country [23] 0 0
Norway
State/province [23] 0 0
Oslo
Country [24] 0 0
Poland
State/province [24] 0 0
Mazowieckie
Country [25] 0 0
Poland
State/province [25] 0 0
Wielkopolskie
Country [26] 0 0
Romania
State/province [26] 0 0
Bucuresti
Country [27] 0 0
Saudi Arabia
State/province [27] 0 0
Jeddah
Country [28] 0 0
Slovenia
State/province [28] 0 0
Ljubljana
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Leon
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Salamanca
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taichung
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04721002
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04721002