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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma (MM)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Multiple Myeloma<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple myeloma (MM), Relapsed/Refractory (R/R) Multiple myeloma (MM), t(11, 14), BCL2