eligibility_summary
Inclusion: Adults ≥18 with MM (IMWG) plus high-risk: high-risk FISH (del17p, t(4,14), t(14,16), 1q amp), R-ISS 3, or extramedullary disease, 50% ultra-high risk (R-ISS3, double-hit, or high-risk+EMD). Transplant-eligible ≤70 or elderly-fit (frailty 0–1), ECOG 0–2, consent/compliance. Exclusion: prior therapy/SCT (except ≤1 cycle/brief steroids), peripheral neuropathy ≥2, AL amyloidosis, MGUS, SMM, plasma cell leukemia, POEMS, MDS, other active cancers <24 mo (except cured early), CNS/meningeal MM.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Open-label phase 2 pilot in de novo high-risk multiple myeloma testing early bispecific T‑cell redirectors with daratumumab. Induction: D‑VRd (daratumumab, anti‑CD38 IgG1 mAb, bortezomib, 26S proteasome inhibitor, lenalidomide, IMiD/CRBN modulator, dexamethasone, corticosteroid). Intensification: Tec‑Dara (teclistamab, BCMA×CD3 bispecific IgG4 that redirects T cells to kill BCMA+ plasma cells, plus daratumumab). If MRD− CR, Tec‑Dara maintenance, if MRD+ or no CR, Early Rescue: Tal‑Dara (talquetamab, GPRC5D×CD3 bispecific that redirects T cells to GPRC5D+ myeloma, plus daratumumab) with possible maintenance. Targets/pathways: BCMA (TNFRSF17), GPRC5D on myeloma, CD3 on T cells (cytotoxic activation), CD38 on myeloma/immune cells (ADCC/CDC/ADCP, immune modulation), ubiquitin‑proteasome (bortezomib), CRBN‑IKZF1/3 degradation and T/NK activation (lenalidomide), steroid‑induced apoptosis.