RecruitingPhase 2NCT06889948

The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland

Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland


Sponsor

Helsinki University Central Hospital

Enrollment

30 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS). The main questions it aims to answer are: Does daratumumab have an effect on the patients' renal function or the amount of proteinuria? Does daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)? Also changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Daratumumab for people with glomerulonephritis, kidney failure, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.


Locations(1)

Helsinki University Hospital

Helsinki, Finland

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NCT06889948


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