Studying Daratumumab Treatment for Kidney Diseases Linked to Monoclonal Gammopathy of Renal Significance MGRS in Adults in Finland

What this Trial Is About

Researchers are evaluating the drug daratumumab to see if it can treat kidney diseases classified as monoclonal gammopathy of renal significance MGRS, excluding AL-amyloidosis. The study aims to understand daratumumabs effects on kidney function, protein levels in urine, and blood markers related to the disease. It also looks at changes in quality of life and activation of the complement system, while tracking patient remission rates and any adverse events related to the drug. Participants will receive either daratumumab alone or daratumumab combined with stem cell transplantation. Daratumumab is given in fixed doses, and treatment cycles last 28 days each. The study includes two treatment groups, with some patients receiving just the drug and others also undergoing stem cell transplantation. Treatment effects and safety are assessed throughout the study period. During participation, patients undergo regular evaluations including kidney function tests such as proteinuria and estimated glomerular filtration rate eGFR, bone marrow minimal residual disease testing, and monitoring for adverse events. Quality of life is assessed using questionnaires. The primary outcome measures focus on kidney remission rates and proteinuria over an average of 12 to 18 months. Patients are monitored closely for changes in blood markers, kidney health, and treatment side effects throughout the study.

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