A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities

Conditions: Multiple Myeloma

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 20

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Location: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin

Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Willing and able to give written informed consent (ICF) . 2. Age ≥ 18 years and ≤ 65 years. 3. Meet the internationally accepted Criteria for the diagnosis of newly diagnosed multiple myeloma (Chinese guidelines for the diagnosis and management of multiple myeloma (revised in 2022) criteria) 4. Patients have not received previous anti-multiple myeloma-related chemotherapy, have not received previous extensive pelvic radiotherapy (more than half of the pelvic area), and 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. 5. The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions: * Serum M protein≥1.0 g/dL(10g/L) * Urine M protein≥200 mg/24h * Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL 6. p53 gene abnormalities: Plasma cells were enriched by CD138 immunomagnetic and then detected by FISH. Cut-off ≥20%., or P53 mutation by second-generation sequencing. 7. ECOG scores 0 - 1; 8. No active infection 9. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria： a.TBIL\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05850286). StuddyBuddy aggregates publicly available trial information.