Bridging Treatment Before CAR-T Therapy for Myeloma Outside the Bone Marrow
Tests aponermin before CAR-T cell infusion in adults with relapsed myeloma spreading outside marrow.
Plain-language title generated from the registry record
Registry title: Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 2 sites
Where in China
- Beijing Gobroad Boren HospitalBeijing, ChinaTaking people
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06793475
- Record updated
- 14 August 2025
- Original description
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.Read full original descriptionShow less
Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study
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.
Inclusion: Be informed and voluntarily sign the Informed Consent Form (ICF); 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; ECOG score is ≤ 2; No active infections; Negative for HBV-DNA, HCV-RNA, and HIV; Liver function meeting the following criteria: Total bilirubin <1.5 × ULN (patients with Gilbert's syndrome must have total bilirubin <3 × ULN), ALT and AST <3 × ULN; Renal function meeting the following criteria: Creatinine clearance ≥30mL/min (calculated using the Cockcroft-Gault formula); Blood tests conducted within 7 days before screening must meet the following standards: WBC count ≥1.0×10⁹/L, Hemoglobin ≥70g/L, Platelet count ≥75×10⁹/L or ≥50×10⁹/L (if ≥50% plasma cells are present in bone marrow); Or as determined appropriate by the investigator; Patients receiving hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], and platelet-stimulating factors such as thrombopoietin [TPO] or interleukin-11) must stop such treatments at least 2 weeks prior to screening; Non-pregnant female patients must confirm pregnancy negativity at screening (via β-hCG serum test or urine pregnancy test); Male patients, female patients of childbearing potential, and their partners must agree to use effective contraception during the treatment period and for at least 3 months after CAR-T cell infusion; Male patients must agree not to donate sperm, starting from the initial screening period until 90 days after the last dose; Patients must agree to comply with study procedures and follow-up visits.
Exclusion: Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment); Infectious diseases (e.g., HIV, active tuberculosis, etc.); Active hepatitis B or hepatitis C infection; Mental or psychological disorders preventing compliance with treatment or treatment evaluation; Severe allergic constitution or severe allergic history, particularly to aponermin, carfilzomib, thalidomide, dexamethasone or other effective components or excipients of related drugs; Significant dysfunction of major organs, such as the heart, lungs, or brain; Patients with severe autoimmune diseases. 11) Any other reasons deemed unsuitable for participation in this study as determined by the investigator; Plasma cell leukemia or solitary plasmacytoma; 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; Abnormal vital signs or inability to cooperate with examinations.