GENESIS: Phase III trial evaluating BL-8040+G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma

Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34(+) hematopoietic stem cells, typically from peripheral blood. A minimum of >= 2 x 10(6) CD34(+) cells/kg are necessary, while transplants of >= 5-6 x 10(6) CD34(+) cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize >= 6.0 x 10(6) CD34(+) cells/kg in up to two apheresis days.