eligibility_summary
Inclusion: IMWG-confirmed, measurable MM, Myeloma Frailty Score: frail or intermediate-fit. Frail: kidney dysfunction allowed (no dialysis), Hb≥7, Plt≥50, ANC≥0.75. Intermediate-fit: ≥1 of CrCl<30, Hb 7–8, Plt 50–75, ANC 0.75–1, or R-ISS III. Imaging (PET/CT), adequate liver/cardiac, HIV/HBV/HCV controlled, ECOG 0–2 (PS3 if due to MM). Exclusion: prior MM therapy (limited exceptions), grade 4 neuropathy, uncontrolled HTN, interfering malignancy, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III trial in frail/intermediate-fit, transplant-ineligible NDMM compares: 1) VRd-Lite induction (bortezomib+lenalidomide+dexamethasone) → lenalidomide maintenance, 2) DRd induction (daratumumab/hyaluronidase+lenalidomide+dexamethasone) → lenalidomide maintenance, 3) DRd induction → daratumumab/hyaluronidase+lenalidomide maintenance. Mechanisms/types: bortezomib (proteasome inhibitor) blocks 26S proteasome, suppresses NF-κB, induces apoptosis of myeloma cells, lenalidomide (IMiD) binds cereblon causing IKZF1/3 degradation, enhances T/NK activity, anti-angiogenic, dexamethasone (glucocorticoid) triggers lymphoid/plasma-cell apoptosis and dampens cytokines, daratumumab (anti-CD38 IgG1 mAb) targets CD38+ plasma cells, mediating CDC, ADCC/ADCP, apoptosis and inhibiting CD38 ectoenzyme, hyaluronidase-fihj (rHuPH20) improves SC delivery. Targets/pathways: CD38+ malignant plasma cells, ubiquitin–proteasome system, cereblon-IKZF axis, immune effector (complement/Fc) pathways, glucocorticoid/NF-κB signaling.