Multiple Myeloma (MM)
Conditions
Keywords
Multiple myeloma (MM), Relapsed/Refractory (R/R) Multiple myeloma (MM), t(11, 14), BCL2
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells | Up to approximately 2.5 months following last subject last visit | 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. |
| Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells | Up to approximately 2.5 months following last subject last visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy | Up to approximately 2.5 months following last subject last visit | t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy. |
| Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy | Up to approximately 2.5 months following last subject last visit | BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy. |
| Percentage of Participants With t(11;14) Status of MM Samples | Up to approximately 2.5 months following last subject last visit | t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy. |
| Percentage of Participants With BCL2 Status of MM Samples | Up to approximately 2.5 months following last subject last visit | BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy. |
| Percentage of Participants Achieving Stability of t(11;14) Status | Up to approximately 2.5 months following last subject last visit | 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. |
| Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages | Up to approximately 2.5 months following last subject last visit | BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy. |
| Percentage of Participants With t(1;14) Status and BCL2 Status | Up to approximately 2.5 months following last subject last visit | 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. |
| Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy | Up to approximately 2.5 months following last subject last visit | FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples as determined by BM biopsy. |
| Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy | Up to approximately 2.5 months following last subject last visit | FISH fusion (F) categories (1F, 2F, \>=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy. |
| Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages | Up to approximately 2.5 months following last subject last visit | t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy. |
| Percentage of Participants Achieving Stability of BCL2 Status | Up to approximately 2.5 months following last subject last visit | Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies. |
Countries
Argentina, Australia, Brazil, Canada, Croatia, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Romania, Saudi Arabia, Slovenia, Spain, Taiwan, Turkey (Türkiye), United States
Outcome results
None listed