Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06889948
PHASE2

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

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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.

Official title: Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-01-19

Completion Date

2027-06

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

DRUG

Daratumumab

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