eligibility_summary
Inclusion: >=18, new MM, no prior anti-myeloma (steroids <=4 wks OK), prior RT for plasmacytoma/lytic OK, on SC daratumumab, consented, concurrent trial allowed, AKI risk with >=2: age >=65, eGFR <60, or recent (14 d) NSAIDs (non-aspirin), bisphosphonates, IV contrast, diuretics, or RAS inhibitors. Exclusion: ESRD/dialysis, AKI (>=1.5x baseline SCr) or RRT, prior anti-CD38/daratumumab, IV daratumumab, nephrotoxic chemo <=30 d (e.g., cisplatin/mTORi), moribund (<30 d).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Prospective observational pilot in newly diagnosed multiple myeloma patients starting standard-of-care subcutaneous daratumumab. Drug: Daratumumab, a human IgG1Îș anti-CD38 monoclonal antibody, mechanism: binds CD38 on malignant plasma cells to induce complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity/phagocytosis, and apoptosis, and depletes CD38+ immunosuppressive cells (immune modulation). Cells/pathways targeted: CD38+ plasma cells and other CD38+ immune subsets, kidney injury pathways monitored via biomarkersâplasma suPAR (uPAR pathway, systemic immune activation) and urinary DKK3 (stress-induced tubular epithelial injury/fibrosis). Aim: pre/post changes to enable early AKI detection.