Clinical Trial

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

Study acronym: DAMOCLES
Recruiting Phase 2
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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.
Trial Details
NCT Number NCT06889948
Lead Sponsor Helsinki University Central Hospital
Collaborators: Janssen, L.P. - Investigator Initiated Studies Program
Conditions Kidney Failure, Paraproteinemias, Glomerulonephritis
Enrollment 30 participants
Start Date 2024-01-19
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-21