Renal rescue for myeloma patients

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1 Renal rescue for myeloma patients Introducing Myeloma Kidney Therapy

2 A new lifeline for myeloma kidney patients Even as they fight their cancer, multiple myeloma patients can be forced to face an unwelcome effect of their condition the serious risk of acute and chronic renal failure. A new therapy under evaluation can help them combat renal impairment and perhaps add a few more and better years of life with their families. Fighting cancer and renal failure Multiple myeloma is a serious and chronic illness. But often renal failure as a further consequence of their disease drastically worsens the patient s condition and shortens the time they have left. Renal failure is caused by an unwelcome by-product of myeloma unmanageable quantities of Free Light Chain (FLC) proteins. A new option for Free Light Chain removal Until now, there has been little success in attempts to use blood purification techniques to remove these damaging molecules, and stop them disrupting the kidneys. But the new Myeloma Kidney Therapy made possible by Gambro could be a lifeline for many of these patients. More time for patients and their families? Initial pilot studies of the new therapy, as well as predictions derived from modeled survival data, point to long-term clinical benefits and a cost-effective use of healthcare resources in comparison with historical controls. 1,2,3,7 The difference for patients and their families can be measured in months and even years. These findings are currently being validated in an on-going randomized controlled trial.

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4 Multiple myeloma and the kidney Myeloma causes the overproduction of proteins that impair renal function and subject the patient to additional complications. Unfortunately current treatments have shown no clinical benefit in the prevention of renal damage. 1 FLCs and cast nephropathy Because of the overgrowth in their plasma cells, many myeloma patients have abnormal levels of FLCs in their blood. When these excessive amounts of FLCs reach the kidneys and pass through the glomerular fenestrations, they overwhelm the absorptive capacity of the proximal tubules. Unchecked, they enter the distal tubules and co-precipitate with Tamm-Horsfall proteins to form waxy casts (cast nephropathy) that both block the flow of urine and cause interstitial inflammation. Immunoglobulin Immunoglobulin Glomerulus Distal tub Glomerulus Distal tubule FLCs Plasma cell FLCs FLCs Proximal tubule: Excessive FLCs cannot be processed ell FLCs Proximal tubule: Excessive FLCs cannot be processed

5 The unwelcome risk of renal failure Approximately 10 20% of multiple myeloma patients experience dialysisdependent acute renal failure. 4,5 Of these patients, studies show that at best little more than a third recover renal function through standard HD, with most of the studies reporting significantly less success. Current treatments are not the answer At present, myeloma kidney patients are treated through attempts to remove FLCs: Plasma exchange is a logical approach, but shows no clinical benefit. 6 A 3.5 L plasma exchange removes 65% of intravascular FLCs but has very little impact on overall FLC levels because they are also present in similar concentrations in the extravascular compartment and tissue edema fluid On the whole, dialyzers are similarly ineffective when used to remove FLCs and do not clear sufficient quantities to offer any real benefit to the patient 1 FLCs + Tamm-Horsfall proteins produce casts (cast nephropathy)

6 A new choice: Myeloma Kidney Therapy A therapy for myeloma kidney patients is now available. Thanks to the emergence of an innovative, new technology from Gambro. A combination of effective chemotherapy, FLC removal and monitoring Initial studies show that the solution for these patients with acute renal failure is Myeloma Kidney Therapy: Effective chemotherapy to reduce the number of malignant, FLC-secreting plasma cells Efficient direct removal of FLCs from the serum Accurate and rapid monitoring of FLC levels to ensure optimized treatment (see end of brochure for details on Freelite immunodiagnostic assays) Theralite High Cut-off technology It is with a new technology for the efficient and direct removal of FLCs that Gambro has been able to provide the missing ingredient. Theralite High Cut-off technology is uniquely successful in removing FLCs because its large pores do not restrict removal. 1 Rapid reduction in serum FLC concentrations Clinical studies report very positive results for Myeloma Kidney Therapy. 2 Through the combination of direct removal using Theralite technology and effective chemotherapy, FLC levels are rapidly reduced. Theralite High Cut-off technology is characterized by very large pores, three times the size of a normal High Flux membrane. During treatment with conventional dialysis techniques, these pores allow larger molecules such as proteins (in the molecular weight range 15 to 45 kda) to pass through the membrane.

7 In combination: Myeloma Kidney Therapy Theralite High Cut-off technology chemotherapy Freelite High Cut-off permeability High Cut-off Low Flux High Flux Middle molecules such as ϐ2m Small molecular weight uremic toxins e.g. urea, creatinin, phosphate FLCs

8 Cost-effective rescue a health economics evaluation Recent pilot studies in the United Kingdom 1,2 indicate that Myeloma Kidney Therapy provides major benefits for patients with acute renal failure associated with multiple myeloma in comparison with historical controls up to 70% may recover renal function. 2 Health economics analyses using a Markov simulation model show that the therapy is cost-effective as well. 7,8 Predicted outcomes with Myeloma Kidney Therapy Greater probability of recovering renal function and greater longterm survival Health economics modeling predicts an average survival of 9.37 months for patients on standard HD. Using Theralite technology that figure becomes 20.1 months. Permanent dialysis can be avoided or at least substantially delayed It is estimated that 90% of all multiple myeloma patients treated with standard HD require permanent dialysis during their lifetime. And 75% of patients may need permanent dialysis after their first presentation of renal failure. With Theralite technology, the modeling shows that only 64% of patients may require permanent dialysis and over 50% of these will not need it until after they experience a multiple myeloma relapse. Average life expectancy based on modeling (in years) Standard HD HD with Theralite Putting budgets to the very best use Myeloma Kidney Therapy, with Theralite High Cut-off technology at its heart, delivers a favorable cost-effectiveness ratio, well within the commonly considered range. 3 Quite simply, it s using resources in the right way, and for the right reasons: to significantly prolong a patient s life with their families and improve the quality of those years. The next step? A randomized controlled trial is on-going to confirm these positive results. But from what we know today, the sooner suitable patients can start Myeloma Kidney Therapy, the better. Contact us today to find out more.

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10 Further reading Projected survival data 7,8 Comparing treatment through Theralite High Cut-off technology with conventional HD, simulation analysis demonstrates that fewer patients are expected to need permanent dialysis (64% vs. 90%). Patients are forecast to gain 0.9 additional years of life (1.7 vs. 0.8) and 0.6 additional QALYs (1.1 vs. 0.5). The table below illustrates the percentage of patients alive at each stage, clearly showing the potential improved survival rate as the two patient groups progress or not. Presentation 1st relapse 2nd relapse 3rd relapse 100% 52.5% 23.9% 10.9% Theralite 100% 18.8% 6.2% 2% Standard HD References Hutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappell MJ, Cook M, Goehl H, Storr M, Bradwell AR. Efficient removal of immunoglobulin free light chains by hemodialysis for multiple myeloma: in vitro and in vivo studies. J Am Soc Nephrol Mar;18(3): Hutchison CA, Basnayake K Cook M, Bradwell AR, Cockwell P. Free Light Chain Hemodialysis Increases Renal Recovery Rate and Improves Patient Survival in Patients with Cast Nephropathy. Nephrol Dial Transplant Jun; 1 (Suppl 2): ii9a, 2008 Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Econ May;13(5): Knudsen LM, Hjorth M, Hippe E. Renal failure in multiple myeloma: reversibility and impact on the prognosis. Nordic Myeloma Study Group. Eur J Haematol Sep;65(3): Clark WF, Stewart AK, Rock GA, Sternbach M, Sutton DM, Barrett BJ, Heidenheim AP, Garg AX, Churchill DN; Canadian Apheresis Group. Plasma exchange when myeloma presents as acute renal failure: a randomized, controlled trial. Ann Intern Med Dec 6;143(11): Grima D. Modeled Long-term Clinical Outcomes and Costeffectiveness of Hemodialysis with the Gambro HCO 1100 Dialyzer Versus Standard Hemodialysis in Patients with Renal Failure Secondary to Multiple Myeloma Available on request from Cornerstone Research Group Inc. 4. Bladé J, Fernández-Llama P, Bosch F, Montolíu J, Lens XM, Montoto S, Cases A, Darnell A, Rozman C, Montserrat E. Renal failure in multiple myeloma: presenting features and predictors of outcome in 94 patients from a single institution. Arch Intern Med Sep 28;158(17): Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Medical Decision Making, Vol.13, No. 4:

11 Ordering information Please contact us to order Theralite High Cut-off technology or receive more information: About Freelite Freelite assays were developed by The Binding Site to measure free lambda and free kappa immunoglobulin light chains. Freelite is an award-winning breakthrough for the detection and monitoring of Multiple Myeloma and other B-cell dyscrasia. For more details about Freelite immunodiagnostic assays including ordering information, please contact:

12 Partners in care... David, Ellen, Tom, Enrico, Beatriz. They are just a handful of the hundreds of thousands of men, women and children around the world who everyday rely on our products and your care to survive kidney or liver conditions and enjoy a better life. Every step we take together, every improvement in care we make, touches lives and provides new hope to José, Xiuxiu, Vladimir, Fred, Jamila... HCEN5379_ Gambro Lundia AB Gambro the pioneer and leading innovator in dialysis therapy passionately committed to promoting life by advancing products, services and customer partnership within renal and hepatic care. Contact us at [email protected] Gambro is a registered trademark of Gambro Lundia AB. Theralite is a trademark of Gambro Lundia AB filed for registration in the European Community and in the United States. Gambro Lundia AB PO Box SE Lund Sweden Phone [email protected]