eligibility_summary
Adults with transplant-ineligible newly diagnosed multiple myeloma and measurable disease who completed 18–20 cycles of D-Rd or Isa-Rd with ≥partial response, ECOG 0–3, able to complete QoL forms (English/French/validated), consented, available for follow-up, start within 2 working days, contraception if applicable. Exclude AL amyloidosis, POEMS, Waldenström, conflicting anti-cancer therapy, active infection ≤7 days, HIV CD4<350 unless on ART≥4 wks, VL<400 (≤16 wks), no OIs in past year.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III non-inferiority RCT in transplant-ineligible, newly diagnosed multiple myeloma tests stopping vs continuing anti-CD38 therapy after 18–20 cycles. Arms: continue daratumumab or isatuximab (IgG1 monoclonal antibodies) plus lenalidomide and dexamethasone vs stop the anti-CD38 and continue lenalidomide+dexamethasone. Mechanisms: Daratumumab/Isatuximab bind CD38 on myeloma plasma cells, inducing ADCC, CDC, and ADCP, direct apoptosis, and depleting CD38+ immunosuppressive cells, enhancing T/NK activity. Lenalidomide is an oral IMiD/CRBN E3 ligase modulator that degrades IKZF1/3, boosts IL-2 and T/NK function, and inhibits angiogenesis/tumor growth. Dexamethasone is a glucocorticoid receptor agonist causing lymphoid apoptosis. Targets/pathways: CD38+ plasma cells, Fc/complement effector pathways, CRBN–IKZF1/3 axis, glucocorticoid signaling.