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Multiple MyelomaPhase 4NCT05429515

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

A Phase 4 study testing HFR-SUPRA, hemodialysis and Chemotherapy in people with Multiple Myeloma and Acute Kidney Injury, run by Peking Union Medical College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
HFR-SUPRA, hemodialysis and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jul 2022to 1 Dec 2032
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

SanXi Ai, MD contact

18811054896

sanxiai@163.com

Yan Qin, MD contact

13718706171

qinyanbeijing@126.com

About this study

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

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

Read the 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.

Being tested
HFR-SUPRA, hemodialysis, Chemotherapy
Medical subject headings
Multiple Myeloma, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFR-SUPRAProcedure or surgery

    Also called haemodiafiltration with ultrafiltrate regeneration by adsorption on resin

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

  • hemodialysisProcedure or surgery

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

  • ChemotherapyDrug

    chemotherapy protocol will be made by hematologists.

Study groups in NCT05429515
Study groupRoleWhat they receive
HFR-SUPRAExperimentalhaemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week.
Receives: Procedure: HFR-SUPRA; Drug: Chemotherapy
HemodialysisActive comparatorhemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.
Receives: Procedure: hemodialysis; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. independence from dialysis at 90 days from allocation to groups

    independence from dialysis at 90 days from allocation to groups

    Measured: 90 days after allocation to groups

Secondary outcomes (8)

  1. independence from dialysis at 6 months from allocation to groups

    independence from dialysis at 6 months from allocation to groups

    Measured: 6 months after allocation to groups

  2. 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

    Measured: 90 days after allocation to groups

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

    decline of free light chain from baseline level

    Measured: 21 days after allocation to groups

  4. hematological remission at 90 days from allocation to groups

    hematological remission at 90 days from allocation to groups

    Measured: 90 days after allocation to groups

  5. hematological remission at 6 months from allocation to groups

    hematological remission at 6 months from allocation to groups

    Measured: 6 months after allocation to groups

  6. time to independence from dialysis

    time to independence from dialysis

    Measured: from allocation to groups to the last time of Hemodialysis or HFR-SUPRA

  7. survival at 12 months

    survival at 12 months

    Measured: 12 months after allocation to groups

  8. adverse events

    adverse events

    Measured: within the 3 months after allocation to groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Jul 2032 (estimated)
  4. Study completion1 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429515
Sponsor's protocol ID
HFR_MM
Status last verified
Apr 2022
First submitted
19 Jun 2022
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 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.

    PubMed 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: 10.1093/annonc/mdt483.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.

    PubMed 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 Mar 11.

    PubMed 30872075

  • 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.

    PubMed 24241366

  • 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.

    PubMed 32539688

  • 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.

    PubMed 30078004

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HFR-SUPRA, hemodialysis and Chemotherapy in people with Multiple Myeloma and Acute Kidney Injury, run by Peking Union Medical College Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SanXi Ai, MD (18811054896, sanxiai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

independence from dialysis at 90 days from allocation to groups (time frame: 90 days after allocation to groups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429515, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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