eligibility_summary
Eligibility: Adults (≥18) with relapsed/refractory multiple myeloma. Phase I: previously treated with anti‑CD38 MoAb plus IMiDs and started on PVD scheme. Phase II: after first-line anti‑CD38 MoAb + IMiDs and started on on‑label regimens. Must understand and sign informed consent and allow clinical data review. Exclusion: not willing to consent to data review.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06541860 is a multicenter observational study of relapsed/refractory multiple myeloma patients double-refractory to an anti-CD38 monoclonal antibody (e.g., daratumumab) and lenalidomide, evaluating outcomes with on‑label salvage regimens (Phase I specifies PVd: pomalidomide‑bortezomib‑dexamethasone). Drug types and mechanisms: anti‑CD38 mAb (daratumumab) targets CD38 on malignant plasma cells, inducing ADCC/CDC and apoptosis, lenalidomide and pomalidomide are IMiDs that bind cereblon, degrade IKZF1/3, enhance T/NK cell activity, and inhibit myeloma growth, bortezomib is a proteasome inhibitor (26S) causing protein stress and apoptosis, impacting NF‑κB signaling, dexamethasone is a glucocorticoid promoting apoptosis via glucocorticoid receptor. Targeted cells/pathways: CD38+ plasma cells, cereblon/IKZF1/3 pathway, ubiquitin‑proteasome system, NF‑κB signaling, and immune effector (T/NK) activation.