eligibility_summary
Include: Adults ≥18, biopsy‑proven MGRS (biopsy ≤3 mo, transplants allowed), proteinuria ≥500 mg/d or eGFR ≥20 ml/min. Exclude: myeloma/systemic AL (smoldering w/ MGRS allowed), cancer requiring treatment, B‑cell malignancy–related MGRS, HIV, HCV/HBV unless controlled, pregnancy/lactation, cyclophosphamide ≤6m, high‑dose steroids ≤6w (≤10 mg ok), MMF/CNI/AZA allowed, stop at daratumumab unless transplant, CD19 reconstitution post‑rituximab, unable to use/comply with daratumumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 2, interventional study in Finland testing daratumumab for MGRS, as single agent or combined with stem cell transplantation. Drug/intervention: Daratumumab is a human IgG1κ monoclonal antibody (immunotherapy) targeting CD38, it kills CD38+ cells via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity/phagocytosis, and apoptosis, and modulates immunity (depletes CD38+ immunosuppressive cells), thereby lowering pathogenic monoclonal Ig/light-chain production. Combination arm adds stem cell transplantation to further eradicate the clonal plasma cell compartment. Target cells/pathways: CD38+ clonal plasma cells driving MGRS, downstream renal injury from monoclonal light chains and complement activation. Trial also interrogates complement activation mechanisms, MRD, and dFLC.