A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects with Multiple Myeloma

Conditions

Hematopoietic Stem Cell mobilization autologous transplantation in Multiple Myeloma

Brief summary

Efficacy Endpoint: Proportion of subjects mobilizing ≥6.0 x 10^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for auto-HCT after G-CSF + single administration of BL-8040 or placebo.

Detailed description

Efficacy Endpoint: Proportion of subjects who collect ≥2.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Efficacy Endpoint: Proportion of subjects who collect ≥6.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Additional Secondary Efficacy Endpoints: Time from transplantation to neutrophil engraftment, defined as ANC ≥ 0.5 x 10^9/L for 3 consecutive days or ≥1.0 x 10^9/L for 1 day following the conditioning regimen associated nadir., Time from transplantation to platelet engraftment, defined as the first of 3 consecutive measurements of platelet count ≥20 x 10^9/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir., Time from transplantation to engraftment, defined as the time to neutrophils and platelets engraftment, whichever comes later., Graft durability at 60 days post-transplantation., Graft durability at 100 days post-transplantation., Graft durability at 6 months post-transplantation., Graft durability at 9 months post-transplantation., Graft durability at 12 months post-transplantation.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBL-8040 Placebo is formulated as a sterile and non-pyrogenic lyophilized powder in a vial containing 50 mg of mannitol. BL-8040 Placebo should be administrated SC following reconstitution with 2 mL 0.45% Sodium Chloride for Injection (Half Normal Saline).

DRUGMOTIXAFORTIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy Endpoint: Proportion of subjects mobilizing ≥6.0 x 10^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for auto-HCT after G-CSF + single administration of BL-8040 or placebo.	—

Secondary

Measure	Time frame
Efficacy Endpoint: Proportion of subjects who collect ≥2.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Efficacy Endpoint: Proportion of subjects who collect ≥6.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Additional Secondary Efficacy Endpoints: Time from transplantation to neutrophil engraftment, defined as ANC ≥ 0.5 x 10^9/L for 3 consecutive days or ≥1.0 x 10^9/L for 1 day following the conditioning regimen associated nadir., Time from transplantation to platelet engraftment, defined as the first of 3 consecutive measurements of platelet count ≥20 x 10^9/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir., Time from transplantation to engraftment, defined as the time to neutrophils and platelets engraftment, whichever comes later., Graft durability at 60 days post-transplantation., Graft durability at 100 days post-transplantation., Graft durability at 6 months post-transplantation., Graft durability at 9 months post-transpla	—

Measure

Time frame

Efficacy Endpoint: Proportion of subjects who collect ≥2.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Efficacy Endpoint: Proportion of subjects who collect ≥6.0 x 10^6 CD34+ cells/kg in 1 apheresis session., Additional Secondary Efficacy Endpoints: Time from transplantation to neutrophil engraftment, defined as ANC ≥ 0.5 x 10^9/L for 3 consecutive days or ≥1.0 x 10^9/L for 1 day following the conditioning regimen associated nadir., Time from transplantation to platelet engraftment, defined as the first of 3 consecutive measurements of platelet count ≥20 x 10^9/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir., Time from transplantation to engraftment, defined as the time to neutrophils and platelets engraftment, whichever comes later., Graft durability at 60 days post-transplantation., Graft durability at 100 days post-transplantation., Graft durability at 6 months post-transplantation., Graft durability at 9 months post-transpla

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Countries

Germany, Hungary, Italy, Spain

Outcome results

None listed