An observational study in Multiple Myeloma (MM), sponsored by AbbVie. Completed at 40 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by AbbVie · Observational
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 514 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma
Exclusion Criteria:
Participants with newly diagnosed and relapsed/refractory multiple myeloma will receive standard of care. Bone marrow and blood samples will be collected.
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.
Time frame: 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.
Time frame: Up to approximately 2.5 months following last subject last visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2.5 months following last subject last visit
Plan to share: Undecided
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