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Freelite®


and Hevylite® Freelite & Hevylite in Guidelines


The International Myeloma Working Group (IMWG) guidelines recommend the use of Freelite by name.


The following guidelines recommend serum free light chain analysis for use in multiple myeloma, MGUS and AL Amyloidosis:


• International Myeloma Working Group1,3,4,5 • International Kidney and Monoclonal Gammopathy Research Group6


• The National Comprehensive Cancer Network7 • The National Institute of Health Care Excellence8 • European Society of Medical Oncology9 • British Committee for Standards in Haematology10-13 • UK Myeloma Forum10-13 • Nordic Myeloma Study Group13 • Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain (AL) amyloidosis14


• Chinese Multiple Myeloma Diagnosis and Treatment Guidelines – version 201515


• Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular Project guidelines: Associação Médica Brasileira – 201216


Hevylite utility is recognised in the following guidelines:


• International Myeloma Working Group17 • British Committee for Standards in Haematology10 • Czech Myeloma Group18 • Polish Myeloma Group19


 diagnosis


Clonal bone marrow plasma cells 10% or biopsy-proven bony or extramedullary plasmacytoma


“the requirement for monoclonal protein presence as part of the diagnostic criteria is not mandatory”


PLUS a myeloma defining event:


One or more biomarkers of malignancy: • Clonal bone marrow plasma cells 60% •


Involved:uninvolved sFLC ratio 100*


• >1 focal lesion on MRI studies *Involved free light chain must be 100mg/L (all FLC values are based on the Freelite assay).


OR


Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder:


Hypercalcaemia, Renal insufficiency, Anaemia, Bone lesions


Accuracy of Different Diagnostic Approaches for Monoclonal Testing


In all studies the addition of Freelite assays to SPE for first line investigation increased the detection of B cell dyscrasia.20-25


Protocols


SPE alone Serum IFE


SPE, serum IFE, urine IFE


SPE/CZE and Freelite


...The serum FLC assay in combination with serum PEL and serum IFE is sufficient to screen for pathological monoclonal plasmaproliferative disorders other than AL, which requires all the serum tests as well as the 24-h urine IFE.


SPE/CZE, Freelite and serum IFE


*Myeloma22 88 94


% of Paraproteins detected AL amyloidosis22 66 74


100 94 n.d.


LCMM25-27


NSMM28


40 - 57 0 n.d.


0 0


100 96 100 68 100 97 100 68


* Myeloma is inclusive of 467 patients with MM (451), NSMM (4), Plasma cell leukaemia (4), Osteosclerotic MM (1), and Indolent Myeloma (7).


The IMWG now acknowledges the benefits of using Hevylite for monitoring oligosecretory multiple myeloma and for overcoming “limitations associated with monitoring -migrating monoclonal IgA by electrophoresis”. Assessment of Hevylite ratios may play “an important role in the definition of a minimal residual disease- negative state”.


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