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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
QLS32015 will be administered subcutaneously.
Pomalidomide will be administered orally.
Selinexor will be administered orally.
National Clinical Research Center for Blood Diseases
Tianjin, Tianjin Municipality, China
RECRUITINGProgression-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.
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
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
Time frame: Up to 4 years
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
Time frame: Up to 4 years
Minimal Residual Disease (MRD) Negativity
MRD negativity is defined as participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy
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Dexamethasone will be administered orally
Time frame: Up to approximately 4 years
Number of Participants with Adverse Events (AEs) by Severity
Number of participants with AEs by Severity will be reported.
Time frame: Up to 4 years
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Change from baseline scores
Time frame: Baseline up to 4 years