Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury

Multiple Myeloma Clinical Trial

Official title:

Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05429515
• Other study ID #: HFR_MM
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: December 1, 2032

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: SanXi Ai, MD
• Phone: 18811054896
• Email: sanxiai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2032
• Est. primary completion date: July 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 to 80 years old

• new onset of multiple myeloma

• acute kidney injury with eGFR < 15 ml/min/1.73m2 and need hemodialysis

• biopsy-proven cast nephropathy or clinical diagnosis of cast nephropathy based on exclusion of other causes of acute kidney injury including post-renal obstruction, hypercalcaemia, amyloidosis, light-chain deposition disease, contrast media and drug nephropathy

• serum light chain > 500 mg/L

Exclusion Criteria:

• chronic kidney disease stage 3 to 5 (eGFR< 60 ml/min/1.73m2 for at least 3 months)

• haemodynamics unstability

• active bleeding

• cardiovascular and cerebrovascular events in the last month

• other malignant tumor

• conditions not suitable to participate in the study, such as bad compliance

Related Conditions & MeSH terms

• Acute Kidney Injury
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Wounds and Injuries

Intervention

Procedure:
• HFR-SUPRA
HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.
• hemodialysis
hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.

Drug:
• Chemotherapy
chemotherapy protocol will be made by hematologists.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Bellco Hoxen Medical (Shanghai) Co., Ltd

References & Publications (11)

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. — View Citation

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. — View Citation

Heyne N, Denecke B, Guthoff M, Oehrlein K, Kanz L, Häring 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Menè 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. — View Citation

Pendón-Ruiz de Mier MV, Alvarez-Lara MA, Ojeda-López R, Martín-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. — View Citation

Pendón-Ruiz de Mier MV, Ojeda R, Álvarez-Lara MA, Navas A, Alonso C, Caballero-Villarraso J, Aljama P, Álvarez MA, Soriano S, Rodríguez M, Martín-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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	complete renal recovery at 90 days from allocation to groups	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
Secondary	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
Secondary	hematological remission at 90 days from allocation to groups	hematological remission at 90 days from allocation to groups	90 days after allocation to groups
Secondary	hematological remission at 6 months from allocation to groups	hematological remission at 6 months from allocation to groups	6 months after allocation to groups
Secondary	time to independence from dialysis	time to independence from dialysis	from allocation to groups to the last time of Hemodialysis or HFR-SUPRA
Secondary	survival at 12 months	survival at 12 months	12 months after allocation to groups
Secondary	adverse events	adverse events	within the 3 months after allocation to groups