Open AccessGENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma
Author(s) -
Zachary Crees,
Keith Stockerl-Goldstein,
Abi Vainstein,
Hemda Chen,
John F. DiPersio
Publication year - 2019
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2019-0380
Subject(s) - apheresis , medicine , cd34 , multiple myeloma , granulocyte colony stimulating factor , haematopoiesis , hematopoietic stem cell transplantation , leukapheresis , plerixafor , transplantation , stem cell , immunology , oncology , chemotherapy , cxcr4 , platelet , biology , immune system , chemokine , genetics
Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34 + hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10 6 CD34 + cells/kg are necessary, while transplants of ≥5-6 × 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 × 10 6 CD34 + cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529.