eligibility_summary
Adults 18–70 with newly diagnosed symptomatic multiple myeloma per CRAB/myeloma‑defining events, measurable disease, R-ISS I, standard-risk SKY92, WHO 0–2, transplant-eligible (high-dose melphalan), adequate organ function/vascular access, able to consent/comply, strict contraception/pregnancy testing. Exclude CNS disease, other plasma cell disorders, nonsecretory MM, recent therapy, key lab/cardiac/pulmonary issues, active HBV/HCV/HIV, recent malignancy, severe neuropathy, hypersensitivity, uncontrolled illness, active infection, or other trial participation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II/III trial in low-risk, newly diagnosed, transplant-eligible multiple myeloma compares: Arm A—3 cycles isatuximab/lenalidomide/bortezomib/dexamethasone (I‑VRd) then high‑dose melphalan with autologous stem-cell transplant (ASCT), Arm B—3 cycles I‑VRd, stem-cell collection, then 3 cycles I‑VRd consolidation without upfront melphalan/ASCT. Both receive isatuximab+lenalidomide maintenance. Drugs/mechanisms: Isatuximab (anti‑CD38 IgG1 mAb) kills CD38+ plasma cells via ADCC/CDC/ADCP and direct apoptosis, Lenalidomide (IMiD) binds cereblon to degrade IKZF1/3, enhances T/NK immunity, inhibits pro‑myeloma cytokines/angiogenesis, Bortezomib (proteasome inhibitor) blocks 26S proteasome, inducing ER stress/apoptosis and inhibiting NF‑κB, Dexamethasone (glucocorticoid) induces lymphoid/myeloma cell apoptosis, Melphalan (alkylator) DNA crosslinks. Targets: clonal BM plasma cells, CD38, proteasome/NF‑κB, cereblon‑IKZF, immune effector pathways, glucocorticoid receptor, DNA damage response.