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

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 Description

Primary Outcome:

• Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
• Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells

• Percentage of Participants Achieving Stability of t(11;14) Status
• Percentage of Participants Achieving Stability of BCL2 Status
• Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy
• Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy
• Percentage of Participants With t(11;14) Status of MM Samples
• Percentage of Participants With BCL2 Status of MM Samples
• Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages
• Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages
• Percentage of Participants With t(1;14) Status and BCL2 Status
• Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy
• Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy

View this trial on ClinicalTrials.gov