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Not yet recruiting NCT05429515

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

Phase IV Interventional Multiple Myeloma Acute Kidney Injury Hemodiafiltration With Ultrafiltrate Regeneration (HFR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HFR-SUPRA, hemodialysis, Chemotherapy.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Acute Kidney Injury, Hemodiafiltration With Ultrafiltrate Regeneration (HFR). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Primary outcome measures

  • independence from dialysis at 90 days from allocation to groups [Time frame: 90 days after allocation to groups]
Secondary outcome measures (8)
  • independence from dialysis at 6 months from allocation to groups [Time frame: 6 months after allocation to groups]
  • complete renal recovery at 90 days from allocation to groups [Time frame: 90 days after allocation to groups]
  • decline of free light chain at 21 days from allocation to groups [Time frame: 21 days after allocation to groups]
  • hematological remission at 90 days from allocation to groups [Time frame: 90 days after allocation to groups]
  • hematological remission at 6 months from allocation to groups [Time frame: 6 months after allocation to groups]
  • time to independence from dialysis [Time frame: from allocation to groups to the last time of Hemodialysis or HFR-SUPRA]
  • survival at 12 months [Time frame: 12 months after allocation to groups]
  • adverse events [Time frame: within the 3 months after allocation to groups]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 PMID 25439696
  • 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: 10.10 PMID 24356630
  • 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. PMID 22997259
  • 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. PMID 22045243
  • 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. PMID 21511832
  • 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. PMID 22170517
  • 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: PMID 29209721
  • 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 PMID 30872075

Identifiers

NCT: NCT05429515 · HFR_MM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗