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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04721002
Registration number
NCT04721002
Ethics application status
Date submitted
21/01/2021
Date registered
22/01/2021
Titles & IDs
Public title
Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
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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
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Secondary ID [1]
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H20-126
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Universal Trial Number (UTN)
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Trial acronym
MEDICI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM)
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 2.5 months following last subject last visit
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Primary outcome [2]
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Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [1]
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Percentage of Participants Achieving Stability of t(11;14) Status
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [2]
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Percentage of Participants Achieving Stability of BCL2 Status
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Assessment method [2]
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Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.
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Timepoint [2]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [3]
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Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy
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Assessment method [3]
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t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy.
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Timepoint [3]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [4]
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Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy
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Assessment method [4]
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BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy.
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Timepoint [4]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [5]
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Percentage of Participants With t(11;14) Status of MM Samples
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Assessment method [5]
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t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy.
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Timepoint [5]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [6]
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Percentage of Participants With BCL2 Status of MM Samples
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Assessment method [6]
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BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy.
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Timepoint [6]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [7]
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Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages
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Assessment method [7]
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t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy.
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Timepoint [7]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [8]
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Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages
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Assessment method [8]
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BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy.
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Timepoint [8]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [9]
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Percentage of Participants With t(1;14) Status and BCL2 Status
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Assessment method [9]
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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.
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Timepoint [9]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [10]
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Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy
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Assessment method [10]
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FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples as determined by BM biopsy.
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Timepoint [10]
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Up to approximately 2.5 months following last subject last visit
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Secondary outcome [11]
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Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy
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Assessment method [11]
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FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy.
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Timepoint [11]
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Up to approximately 2.5 months following last subject last visit
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2023
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Sample size
Target
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Accrual to date
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Final
514
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health /ID# 224386 - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Louisiana
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Argentina
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State/province [3]
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Ciudad Autonoma De Buenos Aires
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Country [4]
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Brazil
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State/province [4]
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Bahia
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Country [5]
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Brazil
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State/province [5]
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Rio Grande Do Sul
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Country [6]
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Brazil
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State/province [6]
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Sao Paulo
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Country [7]
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Brazil
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State/province [7]
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Rio de Janeiro
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Country [8]
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Canada
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State/province [8]
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Alberta
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Country [9]
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Croatia
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State/province [9]
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Grad Zagreb
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Country [10]
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Czechia
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State/province [10]
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Hradec Kralove
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Country [11]
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Czechia
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State/province [11]
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Ostrava
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Country [12]
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France
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State/province [12]
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Hauts-de-France
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Country [13]
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France
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State/province [13]
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Pays-de-la-Loire
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Country [14]
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France
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State/province [14]
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Paris
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Country [15]
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Germany
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State/province [15]
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Berlin
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Country [16]
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Germany
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State/province [16]
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Hamburg
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Country [17]
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Greece
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State/province [17]
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Attiki
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Country [18]
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Ireland
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State/province [18]
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Dublin
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Country [19]
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Israel
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State/province [19]
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Yerushalayim
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Country [20]
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Italy
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State/province [20]
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Ancona
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Country [21]
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Italy
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State/province [21]
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Milano
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Country [22]
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Netherlands
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State/province [22]
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Maastricht
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Country [23]
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Norway
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State/province [23]
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Oslo
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Country [24]
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Poland
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State/province [24]
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Mazowieckie
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Country [25]
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Poland
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State/province [25]
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Wielkopolskie
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Country [26]
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Romania
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State/province [26]
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Bucuresti
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Country [27]
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Saudi Arabia
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State/province [27]
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Jeddah
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Country [28]
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Slovenia
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State/province [28]
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Ljubljana
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Country [29]
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Spain
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State/province [29]
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Barcelona
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Country [30]
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Spain
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State/province [30]
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Leon
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Country [31]
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Spain
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State/province [31]
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Madrid
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Country [32]
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Spain
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State/province [32]
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Salamanca
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Country [33]
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Taiwan
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State/province [33]
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Taichung
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Country [34]
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Turkey
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State/province [34]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04721002
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04721002