This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.
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Patients must have a signed study informed consent prior to entering the study.
Patients must be between the ages of 18 and 78 years.
Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.
Previous history of autologous or allogeneic-HCT.
Failed previous HSC collections or collection attempts.
Dexamethasone: 7 days
Thalidomide: 7 days
Parallel
Motixafortide+G-CSF
DrugPatients will receive the first dose of motixafortide (1.25 mg/kg) by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of motixafortide can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care.
Placebo+G-CSF
DrugPatients will receive the first dose of placebo by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of placebo can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care.
Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions
Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Number of CD34+ cells/kg collected
Maximum plasma concentration (Cmax)
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