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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg.
Apornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment.
Carfilzomib 27mg/m\^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy.
Beijing Gobroad Boren Hospital
Beijing, China
RECRUITINGInstitute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGOverall response rate (ORR)
The definition of ORR is the proportion of participants who achieve a PR or better as the best response according to the IMWG criteria.
Time frame: within 1 months after BCMA/GPRC5D CAR-T infusion
ORR before CAR-T cell infusion
ORR before CAR-T cell infusion is defined as the proportion of participants who achieve a confirmed PR or better as the best response after conditioning treatment but prior to CAR-T cell infusion.
Time frame: before CAR-T cell infusion
Progression free survival(PFS)
Progression free survival is defined as the time from the start of Aponermin treatment to disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 2 year
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the start of Aponermin treatment to the date of the participant's death.
Time frame: Up to 2 year
Adverse events and serious adverse events
Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values
Time frame: Up to 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Thalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment.
Dexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy.