The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood
Department of Internal Medicine V
Heidelberg, Germany
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)
Time frame: Up to four days
To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma
Time frame: 2 months
To determine the efficacy of POL6326 in reconstitution of immune system after transplantation
Time frame: 1 year
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