KIT, SYSTEM AND METHOD OF TREATING MYELOMA PATIENTS

• US 20090112146A1
• Filed: 10/30/2007
• Published: 04/30/2009
• Est. Priority Date: 10/30/2007
• Status: Active Grant

• Current Assignee: Bellco SRL (Medtronic Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Wratten, Mary Lou, Santoro, Antonio, Atti, Mauro
• Granted Patent: US 8,672,869 B2
• Time in Patent Office: Days
• US Class Current: 604/5.40
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0417 Immunoglobulin
• CPC Class Codes: A61M 2202/0445 Proteins

Abstract

Circulating free lambda and kappa free light chains in blood play a role in the pathogenesis of acute renal failure due to myeloma. Coupled plasma filtration and adsorption allows separation of plasma from blood and treatment of the plasma through a cartridge containing a sorbent or resin material, such as hydrophobic divinylbenzene styrenic resins having an average bead diameter of 75 microns, an average pore diameter of 30 nm, and a surface area of 700 m2/g. Lambda and kappa free light chain concentrations progressively decrease during coupled plasma filtration and adsorption treatment resulting in significant reductions by the end of the treatment.

Claims

1. A method of treating a patient having myeloma, the method comprising the steps of:

treating the myeloma patient by extracting the patient'"'"'s p1asma;

removing elevated levels of either lambda or kappa free light chains or both from the patient'"'"'s plasma to obtain purified plasma; and

re-infusing the purified plasma into the patient.

2. The method of claim 1, wherein the step of removing elevated levels of free light chains further comprises removing elevated levels of either lambda or kappa free light chains or both without removing more than about ten percent serum albumin.

3. The method of claim 1, wherein the step of removing elevated levels of free light chains further comprises selectively removing either lambda or kappa free light chains or both by contacting the plasma with a hydrophobic resin, an ion exchange resin, a silica resin, or a combination thereof.

4. The method of claim 1, wherein the step of removing elevated levels of free light chains further comprises selectively removing either lambda or kappa free light chains or both by contacting the plasma with a hydrophobic resin.

5. The method of claim 1, wherein the step of removing elevated levels of free light chains further comprises selectively removing either lambda or kappa free light chains or both by contacting the plasma with a hydrophobic polystyrene resin, an ion exchange resin, a bonded silica resin, or a combination thereof.

6. The method of claim 1, wherein the step of removing elevated levels of free light chains further comprises selectively removing either lambda or kappa free light chains or both by contacting the plasma with a hydrophobic polystyrene resin.

7. The method of claim 1, further comprising the step of administering a drug for treating myeloma or effects thereof.

8. A method of treating a patient having myeloma, the method comprising the steps of:

treating the myeloma patient by extracting the patient'"'"'s plasma;

removing elevated levels of either lambda or kappa free light chains or both from ultrafiltrate to obtain purified ultrafiltrate; and

re-infusing the purified ultrafiltrate into the patient.

9. A method of preventing acute renal failure in a patient diagnosed with myeloma, the method comprising the step of purifying the plasma of the myeloma patient by simultaneously reducing levels of either lambda or kappa free light chains or both;

and reducing the levels of inflammatory mediators or uremic toxins.

10. The method of claim 9, wherein the inflammatory mediators comprise interleukin 6 in the patient'"'"'s blood, vascular endothelial growth factor, or tumor necrosis factor or combinations thereof.

11. A kit for treating patients with myeloma, the kit comprising a high permeability filter and a cartridge to capture either lambda or kappa free light chains or both;

and an optional dialyzer, wherein the kit purifies the plasma of a myeloma patient by removing elevated levels of either lambda or kappa free light chains or both.

12. The kit of claim 11, wherein the kit removes no more than about ten percent serum albumin.

13. The kit of claim 11, wherein the high permeability filter comprises a plasma filter or a high permeability hemodialyzer.

14. The kit of claim 11, wherein the optional dialyzer comprises a low flux hemofilter, a high flux hemofilter, or a high permeability hemofilter.

15. The kit of claim 14, wherein the dialyzer further removes residual lambda and kappa free light chains and smaller toxins with a molecular weight less than 20,000 Daltons.

16. The kit of claim 11, wherein the cartridge comprises a sorbent or resin material comprising a hydrophobic resin, an ion exchange resin, a silica resin, or combinations thereof.

17. The kit of claim 11, wherein the cartridge comprises a hydrophobic resin.

18. The kit of claim 11, wherein the cartridge comprises a sorbent or resin material comprising a hydrophobic polystyrene resin, an ion exchange resin, a bonded silica resin, or combinations thereof.

19. The kit of claim 11, wherein the cartridge comprises a hydrophobic polystyrene resin.

20. The kit of claim 11, wherein the cartridge comprises hydrophobic divinylbenzene styrenic resin.

21. The kit of claim 11, wherein the cartridge has a diameter, height, or resin volume being adjusted to provide a linear flow velocity maximizing the adsorption of either lambda or kappa free light chains or both.

22. The kit of claim 21, wherein the resin volume comprises 50 to 250 ml of the resin.

23. A system for treating myeloma, the system comprising:

a high permeability filter and a cartridge to capture either lambda or kappa free light chains or both; and

an optional dialyzer

wherein, a myeloma patient'"'"'s plasma is purified by removing elevated levels of either lambda or kappa free light chains or both from the patient'"'"'s plasma.

24. The system of claim 23, further comprising re-infusing the purified plasma into the patient.

25. The system of claim 24, further comprising mechanical component, software, hardware, firmware, or combinations thereof.