Multiple Myeloma Clinical Trial
Official title:
Application of Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) as a Surrogate Biomarker of Minimal Residual Diseases for Multiple Myeloma Patients
Despite the significantly higher complete remission rates and improved survival achieved over the last decade，multiple myeloma (MM) patients continue to relapse due to persistence of minimal residual disease (MRD). Currently, numerous studies have evaluated the prognostic value of MRD by detecting immunophenotypic and immunoglobulin (Ig) gene rearrangements from bone marrow aspiration samples. Here the investigators intend to study the clinical utility of Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) as an MRD assay, which is based on plasma cell-free DNA(cfDNA) low-coverage whole-genome sequencing. UCAD is non-invasive and applicable for tumors with high heterogeneity and extramedullary invasions.
In multiple myeloma, Minimal Residual Disease (MRD) refers to myeloma cells that are present
in the bone marrow after a clinical response has been measured and the patient is in
remission. A patient who tests "MRD negative" after treatment for myeloma has less than one
myeloma cell per million bone marrow cells. Data from recent clinical trials suggest that
patients with such a low level of disease may be less likely to experience a relapse of their
condition than patients with higher levels. In recent years, MRD testing is now be applied in
the management of patients receiving standard therapies for the disease.
Chromosomal instability(CIN) results from errors in chromosome segregation during mitosis,
leading to structural and numerical chromosomal abnormalities. It will generate genomic
heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that
tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with
metastasis, treatment resistance, and decreased overall survival. It is estimated that
60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively
correlates with tumor stage and is enriched in relapsed as well as metastatic tumor
specimens. Due to the ubiquity of CIN in cancer cells and cancer cell releasing DNA into
peripheral blood (PB) when apoptosis, it is a potentially non-invasive way to detect CIN in
PB cfDNA from the MM patients to character MRD level. UCAD is a new method to detecting CIN
in the DNA sample from patients, including extracting cfDNA from PB, analyzing DNA by
low-coverage whole-genome sequencing, processing the data by bio-information techniques, and
finally optimizing the management of MM patients.
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