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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2032

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: HFR-SUPRA
    • haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week.
  • Active Comparator: Hemodialysis
    • hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.

Clinical Trial Outcome Measures

Primary Measures

  • independence from dialysis at 90 days from allocation to groups
    • Time Frame: 90 days after allocation to groups
    • independence from dialysis at 90 days from allocation to groups

Secondary Measures

  • independence from dialysis at 6 months from allocation to groups
    • Time Frame: 6 months after allocation to groups
    • independence from dialysis at 6 months from allocation to groups
  • complete renal recovery at 90 days from allocation to groups
    • Time Frame: 90 days after allocation to groups
    • serum creatinine elevation≤ 0.2 mg/dl from baseline or serum creatinine ≤ 1.2 mg/dl if baseline level is unknown
  • decline of free light chain at 21 days from allocation to groups
    • Time Frame: 21 days after allocation to groups
    • decline of free light chain from baseline level
  • hematological remission at 90 days from allocation to groups
    • Time Frame: 90 days after allocation to groups
    • hematological remission at 90 days from allocation to groups
  • hematological remission at 6 months from allocation to groups
    • Time Frame: 6 months after allocation to groups
    • hematological remission at 6 months from allocation to groups
  • time to independence from dialysis
    • Time Frame: from allocation to groups to the last time of Hemodialysis or HFR-SUPRA
    • time to independence from dialysis
  • survival at 12 months
    • Time Frame: 12 months after allocation to groups
    • survival at 12 months
  • adverse events
    • Time Frame: within the 3 months after allocation to groups
    • adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Collaborator
    • Bellco Hoxen Medical (Shanghai) Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yan Qin, MD, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • SanXi Ai, MD, 18811054896, sanxiai@163.com

References

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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.

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.

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.

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.

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.

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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.

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.

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.

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