This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
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Age ≥18 years.
Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy.
Plasma cell leukemia or solitary plasmacytoma.
Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).
Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.