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

NCT05429515 | Not Yet Recruiting Phase 4

• 1 other identifier: HFR_MM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma; Acute Kidney Injury; Hemodiafiltration With Ultrafiltrate Regeneration (HFR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  90 days after allocation to groups

• decline of free light chain at 21 days from allocation to groups

  21 days after 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

  6 months after allocation to groups

Study Arms (2)

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.

Procedure: HFR-SUPRA; Drug: Chemotherapy

Hemodialysis

ACTIVE COMPARATOR

hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.

Procedure: hemodialysis; Drug: Chemotherapy

Interventions

HFR-SUPRA PROCEDURE

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

Also known as: haemodiafiltration with ultrafiltrate regeneration by adsorption on resin

HFR-SUPRA

hemodialysis PROCEDURE

hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.

Hemodialysis

Chemotherapy DRUG

chemotherapy protocol will be made by hematologists.

HFR-SUPRA; Hemodialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old
• new onset of multiple myeloma
• acute kidney injury with eGFR \< 15 ml/min/1.73m2 and need hemodialysis
• serum light chain \> 500 mg/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Bellco Hoxen Medical (Shanghai) Co., Ltd: collaborator

Related Publications (11)

• 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.

  PMID: 25439696 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.

  PMID: 24356630 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.

  PMID: 22997259 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.

  PMID: 22045243 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.

  PMID: 21511832 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.

  PMID: 22170517 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.

  PMID: 29209721 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.

  PMID: 30872075 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.

  PMID: 24241366 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.

  PMID: 32539688 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.

  PMID: 30078004 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Acute Kidney Injury

Interventions

Hemodiafiltration; Renal Dialysis; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Yan Qin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SanXi Ai, MD

CONTACT

18811054896; sanxiai@163.com

Yan Qin, MD

CONTACT

13718706171; qinyanbeijing@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 23, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 23, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share