The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd/Sd for the treatment of relapsed or refractory multiple myeloma.
Age ≥18 years old, regardless of gender.
Subjects should be willing and able to comply with the study schedule and protocols.
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 0.5 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.
Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).
Known hypersensitivity to any of the ingredients of this product.
Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
Disease is considered refractory to pomalidomide and selinexor.
Parallel
QLS32015
DrugQLS32015 will be administered subcutaneously.
Pomalidomide
DrugPomalidomide will be administered orally.
Selinexor
DrugSelinexor will be administered orally.
Dexamethasone
DrugDexamethasone will be administered orally
Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Overall Response (Partial Response [PR] or Better)
Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Very Good Partial Response (VGPR) or Better Response
VGPR or better (Stringent Complete Response \[sCR\]+Complete Response \[CR\]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Complete Response (CR) or Better Response
CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria
Duration of Response (DOR)
DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever
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