This is a randomized, double-blind, multicenter trial,parallel control designed to evaluate treatment with pomalidomide + QL2109 + dexamethasone compared with pomalidomide + DARZALEX FASPRO® + dexamethasone in the participants with relapsed or refractory Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
284
QL2109 will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.
Intervention Description:Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle
Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle
Percentage of Participants With Very Good Partial Response (VGPR) or Better
VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment.
Time frame: from baseline to week 24
Percentage of Participants With Very Good Partial Response (VGPR) or Better
VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment.
Time frame: from baseline to week 12 and week 48
Overall Response Rate
Overall response rate is defined as the percentage of randomized subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response
Time frame: from baseline to week 24 and week 48
Overall survival at 18 months
the probability of being alive 18 months after randomization
Time frame: from baseline to 18 months
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DARZALEX FASPRO® will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs