eligibility_summary
Include: ≥65, newly diagnosed measurable MM per SLiM‑CRAB, non‑transplant eligible (CCI≤1, ECOG≤2), life expectancy >6 mo, able to consent/swallow, adequate marrow/organ function, agree to visits/contraception, French social security. Exclude: other plasma disorders, prior MM therapy, recent RT/plasmapheresis/surgery/investigational drug, other recent cancers, CNS MM, HIV/active HBV/HCV, serious comorbidity/infection/cardiac disease, PCL/POEMS, drug allergies, malabsorption, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm study in newly diagnosed, transplant-ineligible multiple myeloma testing: subcutaneous isatuximab (anti-CD38 IgG1 monoclonal antibody, mediates ADCC/CDC/ADCP, induces apoptosis, inhibits CD38 ectoenzyme) plus bortezomib (boronate proteasome inhibitor, blocks 26S proteasome, suppresses NF-κB, causes ER stress), lenalidomide (IMiD, binds cereblon to degrade Ikaros/Aiolos, enhances T/NK activity, anti-angiogenic), and dexamethasone (glucocorticoid, pro-apoptotic in plasma cells). Targets: CD38+ malignant plasma cells, immune effector pathways, ubiquitin-proteasome axis, cereblon-IKZF1/3 signaling.