The purpose of the study is to compare the efficacy of QLS4131(SC) in combination with QL2109, with or without pomalidomide or lenalidomide, and QLS4131 (SC) in combination with QL2109, and QLS4131 (SC) in combination with Pomalidomide, and QLS4131(SC) in combination with QL2109 and Lenalidomide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
QLS4131 will be administered subcutaneously.
QL2109 will be administered subcutaneously.
Pomalidomide will be self-administered as a single dose orally.
DLT
To evaluate the tolerability and safety of subcutaneous administration of QLS4131 for Injection in combination with other agents in patients with malignant plasma cell neoplasms
Time frame: From time of the first dose of QLS4131 to end of DLT period (28 days)
MTD
To determine the maximum tolerated dose (MTD)
Time frame: Up to 2 years
ORR (Partial Response [PR] or Better)
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.
Time frame: Up to 2 years
Overall Minimal Residual Disease (MRD)
MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.
Time frame: Up to 2 years
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Lenalidomide will be self-administered as a single dose orally.
Dexamethasone will be administered orally or intravenously.