Actively Recruiting
Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-14
20
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of multiple myeloma according to IMWG guidelines
- Relapsed or refractory extramedullary multiple myeloma with at least one prior therapy
- Extramedullary lesions of 2 cm or larger confirmed by exam and imaging or biopsy
- ECOG performance status of 2 or less
- No active infections
- Negative tests for HBV-DNA, HCV-RNA, and HIV
- Liver function with total bilirubin less than 1.5 times ULN (less than 3 times ULN if Gilbert's syndrome), and ALT and AST less than 3 times ULN
- Renal function with creatinine clearance of 30 mL/min or greater
- Blood counts within specified limits within 7 days before screening
- Discontinuation of hematopoietic growth factors at least 2 weeks before screening
- Negative pregnancy test for non-pregnant females at screening
- Agreement to use effective contraception during treatment and for 3 months after CAR-T infusion
- Male patients agree not to donate sperm from screening until 90 days after last dose
- Willingness to comply with all study procedures and follow-up
You will not qualify if you...
- Plasma cell leukemia or solitary plasmacytoma
- Prior exposure to both BCMA- and GPRC5D-targeted therapies
- Resistance to elotuzumab, carfilzomib, or thalidomide
- Pregnant or breastfeeding women or women planning pregnancy within 6 months
- Infectious diseases such as HIV or active tuberculosis
- Active hepatitis B or C infection
- Abnormal vital signs or inability to cooperate with exams
- Mental or psychological disorders interfering with treatment compliance
- Severe allergies especially to study drugs or excipients
- Significant dysfunction of major organs (heart, lungs, brain)
- Severe autoimmune diseases
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Gobroad Boren Hospital
Beijing, China
Actively Recruiting
2
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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