GENESIS: Phase III trial evaluating BL-8040+G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma
GENESIS: Phase III trial evaluating BL-8040+G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma
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DOI：
10.2217/fon-2019-0380
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发表时间：
2019-11-01
期刊：
影响因子：
3.3
通讯作者：
DiPersio, John F.
中科院分区：
文献类型：
--
作者：
Crees, Zachary D.;Stockerl-Goldstein, Keith;DiPersio, John F.
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.
