eligibility_summary
Inclusion: Prior GMMG‑HD8/DSMM XIX patient, ≥1 cycle HDM+ASCT, ≥PR (IMWG), age ≥18, WHO 0–2, negative pregnancy test and contraception, informed consent. Exclusion: GI malabsorption, hypersensitivity to study drugs/IMiDs, strong CYP3A4/5 inhibitors/inducers, systemic AL, PCL, POEMS/Waldenström, anti‑myeloma therapy beyond trial, NYHA III–IV, significant hepatic/renal (CrCl<30) dysfunction, active HBV/HCV/HIV/infections, neuropathy ≥2, recent malignancy, platelets <75, Hb ≤8, ANC <1.0, Ca>14, no thromboprophylaxis, pregnancy/lactation, uncontrolled disease/psychiatric, institutionalized, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests maintenance iberdomide vs iberdomide + isatuximab after ASCT in newly diagnosed multiple myeloma. Drugs/mechanisms: • Iberdomide: oral CELMoD (immunomodulatory agent). Binds cereblon (CRBN) E3 ubiquitin ligase to ubiquitinate/degrade IKZF1/IKZF3, directly suppressing myeloma cells and enhancing anti-tumor immunity (↑T/NK-cell activation, ↓Tregs/cytokines). • Isatuximab: subcutaneous anti-CD38 IgG1 monoclonal antibody. Targets CD38 on myeloma/plasma cells, inducing ADCC, CDC, ADCP, and direct apoptosis, also depletes CD38+ immunosuppressive cells. • Dexamethasone: corticosteroid premed (cycle 1) to mitigate infusion reactions. Targets/pathways: malignant plasma cells in bone marrow, CRBN–IKZF1/3 degradation pathway, CD38 antigen, immune effector functions (NK cells, T cells, macrophages, complement). Primary goal: higher MRD negativity at 2 years.