This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers. Primary objective: The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma. Secondary objective: The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate \[CRR\], progression - free survival \[PFS\], overall survival \[OS\], duration of response \[DOR\], time to response \[TTR\], time to progression \[TTP\], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
F182112 + P
F182112+CD38
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGObjective response rate (ORR)
Time frame: up to 2 years
Progression - Free Survival(PFS)
Time frame: Up to 2 years
Minimal Residual Disease - negative rate
Time frame: Up to 2 years
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 2 years
Overall Survival(OS)
Time frame: Up to 2 years
Duration of Response(DOR)
Time frame: up to 2 years
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