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...
Ausführliche Beschreibung
Autor*in: |
Billingham Lucinda [verfasserIn] Weisel Katja [verfasserIn] Heyne Nils [verfasserIn] Cook Mark [verfasserIn] Hutchison Colin A [verfasserIn] Bradwell Arthur [verfasserIn] Cockwell Paul [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2008 |
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Übergeordnetes Werk: |
In: Trials - BMC, 2006, 9(2008), 1, p 55 |
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Übergeordnetes Werk: |
volume:9 ; year:2008 ; number:1, p 55 |
Links: |
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DOI / URN: |
10.1186/1745-6215-9-55 |
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Katalog-ID: |
DOAJ023811080 |
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10.1186/1745-6215-9-55 doi (DE-627)DOAJ023811080 (DE-599)DOAJ2621ca9f5fb9493c8fb096e21549b9c4 DE-627 ger DE-627 rakwb eng R5-920 Billingham Lucinda verfasserin aut European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <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< Medicine (General) Weisel Katja verfasserin aut Heyne Nils verfasserin aut Cook Mark verfasserin aut Hutchison Colin A verfasserin aut Bradwell Arthur verfasserin aut Cockwell Paul verfasserin aut In Trials BMC, 2006 9(2008), 1, p 55 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:9 year:2008 number:1, p 55 https://doi.org/10.1186/1745-6215-9-55 kostenfrei https://doaj.org/article/2621ca9f5fb9493c8fb096e21549b9c4 kostenfrei http://www.trialsjournal.com/content/9/1/55 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1, p 55 |
spelling |
10.1186/1745-6215-9-55 doi (DE-627)DOAJ023811080 (DE-599)DOAJ2621ca9f5fb9493c8fb096e21549b9c4 DE-627 ger DE-627 rakwb eng R5-920 Billingham Lucinda verfasserin aut European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <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< Medicine (General) Weisel Katja verfasserin aut Heyne Nils verfasserin aut Cook Mark verfasserin aut Hutchison Colin A verfasserin aut Bradwell Arthur verfasserin aut Cockwell Paul verfasserin aut In Trials BMC, 2006 9(2008), 1, p 55 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:9 year:2008 number:1, p 55 https://doi.org/10.1186/1745-6215-9-55 kostenfrei https://doaj.org/article/2621ca9f5fb9493c8fb096e21549b9c4 kostenfrei http://www.trialsjournal.com/content/9/1/55 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1, p 55 |
allfields_unstemmed |
10.1186/1745-6215-9-55 doi (DE-627)DOAJ023811080 (DE-599)DOAJ2621ca9f5fb9493c8fb096e21549b9c4 DE-627 ger DE-627 rakwb eng R5-920 Billingham Lucinda verfasserin aut European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <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< Medicine (General) Weisel Katja verfasserin aut Heyne Nils verfasserin aut Cook Mark verfasserin aut Hutchison Colin A verfasserin aut Bradwell Arthur verfasserin aut Cockwell Paul verfasserin aut In Trials BMC, 2006 9(2008), 1, p 55 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:9 year:2008 number:1, p 55 https://doi.org/10.1186/1745-6215-9-55 kostenfrei https://doaj.org/article/2621ca9f5fb9493c8fb096e21549b9c4 kostenfrei http://www.trialsjournal.com/content/9/1/55 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1, p 55 |
allfieldsGer |
10.1186/1745-6215-9-55 doi (DE-627)DOAJ023811080 (DE-599)DOAJ2621ca9f5fb9493c8fb096e21549b9c4 DE-627 ger DE-627 rakwb eng R5-920 Billingham Lucinda verfasserin aut European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <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< Medicine (General) Weisel Katja verfasserin aut Heyne Nils verfasserin aut Cook Mark verfasserin aut Hutchison Colin A verfasserin aut Bradwell Arthur verfasserin aut Cockwell Paul verfasserin aut In Trials BMC, 2006 9(2008), 1, p 55 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:9 year:2008 number:1, p 55 https://doi.org/10.1186/1745-6215-9-55 kostenfrei https://doaj.org/article/2621ca9f5fb9493c8fb096e21549b9c4 kostenfrei http://www.trialsjournal.com/content/9/1/55 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1, p 55 |
allfieldsSound |
10.1186/1745-6215-9-55 doi (DE-627)DOAJ023811080 (DE-599)DOAJ2621ca9f5fb9493c8fb096e21549b9c4 DE-627 ger DE-627 rakwb eng R5-920 Billingham Lucinda verfasserin aut European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <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< Medicine (General) Weisel Katja verfasserin aut Heyne Nils verfasserin aut Cook Mark verfasserin aut Hutchison Colin A verfasserin aut Bradwell Arthur verfasserin aut Cockwell Paul verfasserin aut In Trials BMC, 2006 9(2008), 1, p 55 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:9 year:2008 number:1, p 55 https://doi.org/10.1186/1745-6215-9-55 kostenfrei https://doaj.org/article/2621ca9f5fb9493c8fb096e21549b9c4 kostenfrei http://www.trialsjournal.com/content/9/1/55 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1, p 55 |
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English |
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<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< |
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<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< |
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<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< |
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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<</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medicine (General)</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Weisel Katja</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Heyne Nils</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Cook Mark</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield 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