OncoMatch/Clinical Trials/NCT05850286
A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities
Is NCT05850286 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including anti-BCMA CAR-T and VRD-based Regimen for multiple myeloma.
Treatment: anti-BCMA CAR-T · VRD-based Regimen — This is a single-arm, open-label study to evaluate the efficacy and safety of VRD(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: TP53 abnormality (FISH, cut-off ≥20%)
p53 gene abnormalities: Plasma cells were enriched by CD138 immunomagnetic and then detected by FISH. Cut-off ≥20%.
Required: TP53 mutation
or P53 mutation by second-generation sequencing
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
have not received previous anti-multiple myeloma-related chemotherapy
Cannot have received: hormonal therapy
Exception: hormones for no more than 14 days for symptom control
have not received previous anti-multiple myeloma hormone therapy, except for those who have used hormones for no more than 14 days for symptom control
Cannot have received: radiation therapy
Exception: no previous extensive pelvic radiotherapy (more than half of the pelvic area)
have not received previous extensive pelvic radiotherapy (more than half of the pelvic area)
Lab requirements
Blood counts
WBC ≥ 1.5 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L, PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%)
Kidney function
Creatinine clearance ≥ 60mL/min (Cockroft-Gault formula)
Liver function
TBIL <1.5 x ULN (<3 x ULN in patients with Gilbert's syndrome); AST and ALT <3 x ULN
Cardiac function
normal pulmonary function and oxygen saturation ≥ 92% on room air; LVEF <50% excluded; CHF classification ≥ grade 3 (NYHA) excluded
Screening laboratory values must meet the following criteria： a.TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 60mL/min (calculated using Cockroft-Gault formula). ... WBC ≥ 1.5 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L PLY ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%) ... normal pulmonary function and oxygen saturation ≥ 92% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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