This research project includes patients with relapsed/refractory multiple myeloma (r/r MM) who have received more than three lines of treatment, including those with secondary recurrence, SCT recurrence, and refractory cases. Through this study, we aim to preliminarily determine the effectiveness of the treatment for r/r MM, with the expectation of providing new treatment methods to improve the survival rate of patients with r/r MM.
The patient or their guardian understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examinations and treatments of the research procedures;
Age 18-75 years (inclusive), gender not limited;
According to the IMWG diagnostic criteria, patients diagnosed with multiple myeloma;
Based on any of the following criteria, measurable lesions are determined during the screening: the level of single-clonal paraprotein (M-protein) in the blood ≥ 1.0 g/dL or the M-protein level in urine ≥ 200 mg/24 hours; or a light chain-type multiple myeloma diagnosed as having no measurable lesions in serum or urine: the free light chain of serum immunoglobulin ≥ 10 mg/dL and the abnormal ratio of free light chains of serum immunoglobulin κ/γ;
Within 3 years, diagnosed with or treated for any other aggressive malignant tumor other than multiple myeloma;
Previously received the following anti-tumor treatments (before collecting and preparing the CAR-T cells): within 14 days or at least 5 half-lives (whichever is shorter) received targeted therapy, epigenetic therapy or experimental drug treatment, or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulatory agent treatment within 7 days; received radiotherapy within 14 days (except for fields covering ≤5% of bone marrow reserves);
Suspected that MM has involved the central nervous system or meninges and confirmed by MRI or CT, or has other active central nervous system diseases;
At the screening stage, had Waldenström macroglobulinemia, POEMS syndrome (multiple neuropathy, organ enlargement, endocrine lesion, monoclonal protein disease and skin changes) or primary AL amyloidosis;
Donghua Zhang
Lead sponsor
Tongji Hospital
Sponsor institution