European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial
<p>Abstract</p> <p>Background</p> <p>Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of hig...
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| Format: | Article |
| Language: | English |
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BMC
2008-09-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/9/1/55 |
| _version_ | 1811277728435929088 |
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| author | Billingham Lucinda Weisel Katja Heyne Nils Cook Mark Hutchison Colin A Bradwell Arthur Cockwell Paul |
| author_facet | Billingham Lucinda Weisel Katja Heyne Nils Cook Mark Hutchison Colin A Bradwell Arthur Cockwell Paul |
| author_sort | Billingham Lucinda |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs) in patients' sera. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option.</p> <p>Methods</p> <p>The <b>EU</b>ropean trial of free <b>LI</b>ght chain removal by ex<b>TE</b>nded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefits of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute renal failure and <it>de novo </it>multiple myeloma. Recruitment commenced in May 2008. In total, 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy consists of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken with two Gambro HCO 1100 dialysers in series using an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival.</p> <p>Hypothesis</p> <p>FLC removal haemodialysis will increase the rate of renal recovery in patients with severe renal failure secondary to cast nephropathy in <it>de novo </it>multiple myeloma.</p> <p>Trial registration</p> <p>ISRCTN45967602</p> |
| first_indexed | 2024-04-13T00:21:59Z |
| format | Article |
| id | doaj.art-2621ca9f5fb9493c8fb096e21549b9c4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T00:21:59Z |
| publishDate | 2008-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2621ca9f5fb9493c8fb096e21549b9c42022-12-22T03:10:44ZengBMCTrials1745-62152008-09-01915510.1186/1745-6215-9-55European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trialBillingham LucindaWeisel KatjaHeyne NilsCook MarkHutchison Colin ABradwell ArthurCockwell Paul<p>Abstract</p> <p>Background</p> <p>Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs) in patients' sera. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option.</p> <p>Methods</p> <p>The <b>EU</b>ropean trial of free <b>LI</b>ght chain removal by ex<b>TE</b>nded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefits of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute renal failure and <it>de novo </it>multiple myeloma. Recruitment commenced in May 2008. In total, 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy consists of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken with two Gambro HCO 1100 dialysers in series using an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival.</p> <p>Hypothesis</p> <p>FLC removal haemodialysis will increase the rate of renal recovery in patients with severe renal failure secondary to cast nephropathy in <it>de novo </it>multiple myeloma.</p> <p>Trial registration</p> <p>ISRCTN45967602</p>http://www.trialsjournal.com/content/9/1/55 |
| spellingShingle | Billingham Lucinda Weisel Katja Heyne Nils Cook Mark Hutchison Colin A Bradwell Arthur Cockwell Paul European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial Trials |
| title | European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial |
| title_full | European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial |
| title_fullStr | European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial |
| title_full_unstemmed | European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial |
| title_short | European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial |
| title_sort | european trial of free light chain removal by extended haemodialysis in cast nephropathy eulite a randomised control trial |
| url | http://www.trialsjournal.com/content/9/1/55 |
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