The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Males or females ≥ 18 years of age 2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. 3. Renal biopsy confirmed MGRS-disease * Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted. * Renal transplant patients are allowed 4. Amount of proteinuria ≥ 500 mg/24 h OR eGFR ≥ 20 ml/min prior to the study 5. Previous anticlonal treatment is allowed if deemed ineffective Exclusion Criteria: 1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association