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| Name | Class |
|---|---|
| Bellco Hoxen Medical (Shanghai) Co., Ltd | UNKNOWN |
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In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.
In patients with multiple myeloma-related severe acute kidney injury, compare the renal outcome between patients receiving HFR-SUPRA and patients receiving hemodialysis. Both groups of patients receive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFR-SUPRA | Experimental | haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week. |
|
| Hemodialysis | Active Comparator | hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFR-SUPRA | Procedure | HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| independence from dialysis at 90 days from allocation to groups | independence from dialysis at 90 days from allocation to groups | 90 days after allocation to groups |
| Measure | Description | Time Frame |
|---|---|---|
| independence from dialysis at 6 months from allocation to groups | independence from dialysis at 6 months from allocation to groups | 6 months after allocation to groups |
| complete renal recovery at 90 days from allocation to groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SanXi Ai, MD | Contact | 18811054896 | sanxiai@163.com | |
| Yan Qin, MD | Contact | 13718706171 | qinyanbeijing@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Qin, MD | Peking Union Medical College Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25439696 | Background | Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26. | |
| 24356630 |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D017583 | Hemodiafiltration |
| D006435 | Renal Dialysis |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D006440 | Hemofiltration |
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Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
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| hemodialysis | Procedure | hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis. |
|
| Chemotherapy | Drug | chemotherapy protocol will be made by hematologists. |
|
serum creatinine elevation≤ 0.2 mg/dl from baseline or serum creatinine ≤ 1.2 mg/dl if baseline level is unknown
| 90 days after allocation to groups |
| decline of free light chain at 21 days from allocation to groups | decline of free light chain from baseline level | 21 days after allocation to groups |
| hematological remission at 90 days from allocation to groups | hematological remission at 90 days from allocation to groups | 90 days after allocation to groups |
| hematological remission at 6 months from allocation to groups | hematological remission at 6 months from allocation to groups | 6 months after allocation to groups |
| time to independence from dialysis | time to independence from dialysis | from allocation to groups to the last time of Hemodialysis or HFR-SUPRA |
| survival at 12 months | survival at 12 months | 12 months after allocation to groups |
| adverse events | adverse events | within the 3 months after allocation to groups |
| Background |
| Dimopoulos MA, Delimpasi S, Katodritou E, Vassou A, Kyrtsonis MC, Repousis P, Kartasis Z, Parcharidou A, Michael M, Michalis E, Gika D, Symeonidis A, Pouli A, Konstantopoulos K, Terpos E, Kastritis E. Significant improvement in the survival of patients with multiple myeloma presenting with severe renal impairment after the introduction of novel agents. Ann Oncol. 2014 Jan;25(1):195-200. doi: 10.1093/annonc/mdt483. |
| 22997259 | Background | Sanders PW. Mechanisms of light chain injury along the tubular nephron. J Am Soc Nephrol. 2012 Nov;23(11):1777-81. doi: 10.1681/ASN.2012040388. Epub 2012 Sep 20. |
| 22045243 | Background | Hutchison CA, Batuman V, Behrens J, Bridoux F, Sirac C, Dispenzieri A, Herrera GA, Lachmann H, Sanders PW; International Kidney and Monoclonal Gammopathy Research Group. The pathogenesis and diagnosis of acute kidney injury in multiple myeloma. Nat Rev Nephrol. 2011 Nov 1;8(1):43-51. doi: 10.1038/nrneph.2011.168. |
| 21511832 | Background | Hutchison CA, Cockwell P, Stringer S, Bradwell A, Cook M, Gertz MA, Dispenzieri A, Winters JL, Kumar S, Rajkumar SV, Kyle RA, Leung N. Early reduction of serum-free light chains associates with renal recovery in myeloma kidney. J Am Soc Nephrol. 2011 Jun;22(6):1129-36. doi: 10.1681/ASN.2010080857. Epub 2011 Apr 21. |
| 22170517 | Background | Heyne N, Denecke B, Guthoff M, Oehrlein K, Kanz L, Haring HU, Weisel KC. Extracorporeal light chain elimination: high cut-off (HCO) hemodialysis parallel to chemotherapy allows for a high proportion of renal recovery in multiple myeloma patients with dialysis-dependent acute kidney injury. Ann Hematol. 2012 May;91(5):729-735. doi: 10.1007/s00277-011-1383-0. Epub 2011 Dec 15. |
| 29209721 | Background | Bridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924. |
| 30872075 | Background | Hutchison CA, Cockwell P, Moroz V, Bradwell AR, Fifer L, Gillmore JD, Jesky MD, Storr M, Wessels J, Winearls CG, Weisel K, Heyne N, Cook M. High cutoff versus high-flux haemodialysis for myeloma cast nephropathy in patients receiving bortezomib-based chemotherapy (EuLITE): a phase 2 randomised controlled trial. Lancet Haematol. 2019 Apr;6(4):e217-e228. doi: 10.1016/S2352-3026(19)30014-6. Epub 2019 Mar 11. |
| 24241366 | Background | Pendon-Ruiz de Mier MV, Alvarez-Lara MA, Ojeda-Lopez R, Martin-Malo A, Carracedo J, Caballero-Villarraso J, Alonso C, Aljama P. Effectiveness of haemodiafiltration with ultrafiltrate regeneration in the reduction of light chains in multiple myeloma with renal failure. Nefrologia. 2013 Nov 13;33(6):788-96. doi: 10.3265/Nefrologia.pre2013.Sep.12176. English, Spanish. |
| 32539688 | Background | Pendon-Ruiz de Mier MV, Ojeda R, Alvarez-Lara MA, Navas A, Alonso C, Caballero-Villarraso J, Aljama P, Alvarez MA, Soriano S, Rodriguez M, Martin-Malo A. Hemodiafiltration with ultrafiltrate regeneration reduces free light chains without albumin loss in multiple myeloma patients. BMC Nephrol. 2020 Jun 15;21(1):227. doi: 10.1186/s12882-020-01885-8. |
| 30078004 | Background | Mene P, Giammarioli E, Fofi C, Antolino G, Verde G, Tafuri A, Punzo G, Festuccia F. Serum Free Light Chains Removal by HFR Hemodiafiltration in Patients with Multiple Myeloma and Acute Kidney Injury: a Case Series. Kidney Blood Press Res. 2018;43(4):1263-1272. doi: 10.1159/000492408. Epub 2018 Aug 3. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005112 |
| Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |