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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Patients 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.
Patients 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.
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGHarbin The First Hospital
Harbin, Hei Longjiang, China
NOT_YET_RECRUITINGProportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions
Time frame: Up to day 6
Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Time frame: Up to Day 5
Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Time frame: Up to Day 5
Number of CD34+ cells/kg collected
Time frame: Up to Day 8
Maximum plasma concentration (Cmax)
Time frame: Up to Day 8
Time from transplantation to neutrophil engraftment
Time frame: Up to post transplantation Day 29
Time from transplantation to platelets engraftment
Time frame: Up to post transplantation Day 29
Graft durability at 100 days post-transplantation
Graft durability is defined as maintenance of at least 2 of the following 3 criteria: * Platelet count ≥50 × 10\^9/L without transfusion for at least 2 weeks. * Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month. * Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L for 1 week.
Time frame: Up to post transplantation Day 100
Change from Baseline in peripheral blood CD34+ cell concentration
Time frame: Up to Day 8
Incidence of adverse events (AEs) and serious adverse events (SAEs)
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Time frame: Up to Day 38