Myeloma Clinical Trial
Official title:
Place of the Hevylite Test in the Evaluation of MRD in Myeloma
Study aiming at testing the positive predictive value of the Hevylite blood test in detecting minimal residual disease in myeloma compared to an invasive method requiring bone marrow sample by multi-parametric flow cytometry
Multiple Myeloma is a pathology for which treatments are constantly progressing. These
treatments allow more and more patients to reach deeper and deeper responses. Currently, it
is possible to detect very low levels of disease : this is called the evaluation of minimal
residual disease. Its prognostic value is strong.
Two techniques currently prevail in the evaluation of minimal residual disease: high
throughput sequencing (NGS) and multi-parameter flow cytometry. They are included in
evaluation criteria defined by the International Myeloma Working Group (IMWG). These
techniques have the advantage of being very sensitive, reaching 10-5 (cytometry: 50 events
among 5 000 000 cells analysed) to 10-6 (NGS). Nevertheless, they are invasive for the
patient (medullary specimen), require technical expertise and are not necessarily available
in all hospitals.
The development of blood tests would cope with this constraints.
The Hevylite® assay is a simple, sensitive, automated and inexpensive immunologic technique
that allows the accurate quantification of total IgG, Total IgG, Total IgA, Total IgA L,
Total IgM, and Total IgM in the blood. Given its characteristics, the Hevylite assay could
play a role in the definition of MRD and allow evaluation of residual disease in myeloma.
This study aims to evaluate the positive predictive value of the Hevylite test in the
evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry
on the bone marrow.
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