Prognosis
   

Freelite® - Recommended for use in Prognosis

Identify your high risk patients quickly

Freelite® can help you identify patients with a high risk of progression and poor prognosis as it is an independent prognostic indicator in Multiple Myeloma (MM) patients

The International Myeloma Working Group guidelines recognise Freelite® as an important prognostic tool for MGUS, smouldering and active Multiple Myeloma (MM) solitary plasmacytoma and AL amyloidosis. In conjunction to this several publications relating to over 1600 patients have highlighted Freelite® as an independent marker of prognosis in plasma cell dyscrasias.
The advice was based upon results obtained in extensive clinical trials using the polyclonal Freelite® assays.1

Author

Patient Number Detail
van Rhee et al2 301 "High baseline SFLC levels were a reflection of higher tumour burden, higher degree of disease aggressiveness and light-chain-only MM with its greater propensity for renal failure."
Kyrtsonis et al3 94 "The 5-year disease-specific survival was 82% and 30% in patients with sFLCR lower than and equal or greater than the median, respectively (P=0.0001). sFLCR was an independent prognostic factor."
Snozek et al4 1027 "The serum FLC ratio at initial diagnosis is an important predictor of prognosis in myeloma."
Kyrtsonis et al5 214 In conclusion, baseline sFLCR appears to be an easily determined powerful, independent and very promising novel prognostic factor for survival in patients with newly diagnosed MM."
Dispenzieri et al6 273 "An abnormal ratio proved to be an independent predictor of adverse outcome - in the case of SMM - progression to active MM."
van Rhee et al2 301 "Unlike baseline and follow up serum and urine M proteins, high sFLC levels at baseline-reflecting more aggressive disease- and steeper reductions after therapy identified patients withinferior survival"

 

 

An abnormal Freelite® serum free light chain ratio has been identified as an important, independent risk factor for progression of MGUS to myeloma or related malignancies.
Monoclonal gammopathy of undetermined significance (MGUS) is an asymptomatic condition that occurs in 1% of the population over 50 years of age, and >3% over 70 years of age. It is traditionally associated with the presence of a low level monoclonal band (<20g/L) in the serum, usually no light chains in the urine and <5% plasma cells in the bone marrow. Monitoring of MGUS patients is essential as a significant percentage (approximately 1% per annum) progress to develop Multiple Myeloma or related malignant condition.

Risk stratification

In a study of 1148 MGUS patients seen at the Mayo Clinic between 1960 and 1994, an abnormal Freelite® serum kappa/ lambda ratio was identified as a major independent risk factor for progression of MGUS to myeloma or a related malignancy.7
This risk stratification identified a low risk subset (40%) with a remarkable, small life-time risk of progression, only 2% over 20 years. 

 
Risk group
Numbers of Patients
Absolute risk of progression at 20 years*
LOW
(serum M protein <1.5 gm/dL, IgG subtype, Normal Freelite® ratio)
449
2%
LOW INTERMEDIATE RISK
(Any 1 factor abnormal)
420
10%
HIGH INTERMEDIATE RISK
(Any 2 factors abnormal)
226
18%
HIGH RISK
(All 3 factors abnormal)
53
27%

* accounting for death as a competing risk

This research was originally published in Blood: Rajkumar et al. Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance. Blood 2005; 106:812-817 ©2005 The American Society of Hematology.


 

 

Bloodfig 3Risk of progression of MGUS to myeloma or related disorder using a risk-stratification model that incorporates the Freelite® FLC ratio and the size and type of the serum monoclonal protein. The top curve illustrates risk of progression with time in patients with all 3 risk factors, namely an abnormal serum kappa-lambda FLC ratio (< 0.26 or >1.65), a high serum monoclonal protein level (> 15 g/L), and non-IgG MGUS; the second gives the risk of progression in patients with any 2 of these risk factors; the third curve illustrates the risk of progression with one of these risk factors; the bottom curve is the risk of progression for patients with none of the risk factors.

This research was originally published in Blood: Rajkumar et al. Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance. Blood 2005; 106:812-817 ©2005 The American Society of Hematology.
  • Freelite® can contribute to the management of your MGUS patients
     
  • Low risk patients may account for 40% of all MGUS patients7
     
  • Freelite® enables you to provide reassurance to low risk MGUS patients.
     
  • High risk patients may account for 5% of all MGUS patients7
     
  • Freelite enables you to identify high risk patients and monitor more closely
     
  • Risk stratification of MGUS patients with Freelite® will enable you to allocate resources appropriately
  •  Provide important prognostic information in MM, Smouldering MM, AL amyloidosis6 and solitary bone plasmacytoma8
     
  • Allow risk stratification of MGUS patients and enable identification of high risk patients7 
     
  • Enhance detection rates of screening protocols9,10 
     
  • Facilitate replacement of urine Bence Jones Protein (uBJP) analysis during initial investigations11,12
  1. Dispenzieri A, et al. International Myeloma Working Group Guidelines. Leukemia 2009; 23:215-224 Request your copy - code MKG514
  2. Frits van Rhee, et al. High serum-free light chain levels and their rapid reduction in response to therapy define an aggressive multiple myeloma subtype with poor prognosis. Blood 2007; 110(3):827-832 
  3. Marie-Christine Kyrtsonis, et al. Prognostic value of serum free light chain ratio at diagnosis in multiple myeloma. British Journal of Haematology 2007; 137:240-243 Request your copy - code MKG370
  4. CLH Snozek, et al. Prognostic value of the serum free light chain ratio in newly diagnosed myeloma: proposed incorporation into the international staging system. Leukemia advance online publication, 3 July 2008; doi:10.1038/leu.2008.171 Request your copy - code MKG452
  5. Marie-Christine Kyrtsonis, et al. Serum free light chain measurement aids the diagnosis of myeloma in patients with severe renal failure. Blood 2007; 110:1490a
  6. A Dispenzieri, et al. Immunoglobulin free light chain ratio is an independent risk factor for progression of smoldering (asymptomatic) multiple myeloma. Blood 2008 111(2):785-789 Request your copy - code MKG414
  7. S.Vincent Rajkumar, et al. Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance (MGUS). Blood 2005;106;3: 812-817
  8. Dingli, et al. Immunoglobulin free light chains and solitary plasmacytoma of bone. Blood 2006;108(6):1979-1983
  9. Bakshi, et al. Serum Free Light Chain (FLC) Measurement Can Aid Capillary Zone Electrophoresis in Detecting Subtle FLC Producing M Proteins. Am J Clin Pathol 2005; 124: 214-218 Request your copy - code MKG261
  10. Abadie, et al. Assessment of Serum Free Light Chain Assays for Plasma Cell Disorder Screening in a Veterans Affairs Population. Ann Clin & Lab Sci 2006;36(2):157-162 
  11. J. A. Katzmann, et al. Elimination of the Need for Urine Studies in the Screening Algorithm for Monoclonal Gammopathies by Using Serum Immunofixation and Free Light Chain Assays. Mayo Clin Proc. 2006;81(12):1575-1578 Request your copy - code MKG343
  12. P. G. Hill, et al. Serum Free Light Chains: An Alternative Test to Urine Bence Jones Proteins When Screening for Monoclonal Gammopathies. Clin Chem 2006 52: 1743-1748 Request your copy - code MKG326