Publication: Plerixafor and granulocyte colony-stimulating factor for first-line steady-state autologous peripheral blood stem cell mobilization in lymphoma and multiple myeloma: results of the prospective PREDICT trial.
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Identifiers
Date
2013-02-01
Authors
Russell, Nigel
Douglas, Kenny
Ho, Anthony D
Mohty, Mohamad
Carlson, Kristina
Ossenkoppele, G J
Milone, Giuseppe
Ortiz Pareja, Macarena
Shaheen, Daniel
Willemsen, Arnold
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Ferrata Storti Foundation
Abstract
In Europe, the combination of plerixafor + granulocyte colony-stimulating factor is approved for the mobilization of hematopoietic stem cells for autologous transplantation in patients with lymphoma and myeloma whose cells mobilize poorly. The purpose of this study was to further assess the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization in European patients with lymphoma or myeloma. In this multicenter, open label, single-arm study, patients received granulocyte colony-stimulating factor (10 μg/kg/day) subcutaneously for 4 days; on the evening of day 4 they were given plerixafor (0.24 mg/kg) subcutaneously. Patients underwent apheresis on day 5 after a morning dose of granulocyte colony-stimulating factor. The primary study objective was to confirm the safety of mobilization with plerixafor. Secondary objectives included assessment of efficacy (apheresis yield, time to engraftment). The combination of plerixafor + granulocyte colony-stimulating factor was used to mobilize hematopoietic stem cells in 118 patients (90 with myeloma, 25 with non-Hodgkin's lymphoma, 3 with Hodgkin's disease). Treatment-emergent plerixafor-related adverse events were reported in 24 patients. Most adverse events occurred within 1 hour after injection, were grade 1 or 2 in severity and included gastrointestinal disorders or injection-site reactions. The minimum cell yield (≥ 2 × 10(6) CD34(+) cells/kg) was harvested in 98% of patients with myeloma and in 80% of those with non-Hodgkin's lymphoma in a median of one apheresis. The optimum cell dose (≥ 5 × 10(6) CD34(+) cells/kg for non-Hodgkin's lymphoma or ≥ 6 × 10(6) CD34(+) cells/kg for myeloma) was harvested in 89% of myeloma patients and 48% of non-Hodgkin's lymphoma patients. In this prospective, multicenter European study, mobilization with plerixafor + granulocyte colony-stimulating factor allowed the majority of patients with myeloma or non-Hodgkin's lymphoma to undergo transplantation with minimal toxicity, providing further data supporting the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma or myeloma.
Description
Journal Article; Research Support, Non-U.S. Gov't;. (clinicalTrials.gov identifier: NCT00838357).
MeSH Terms
Medical Subject Headings::Geographicals::Geographic Locations::Europe
Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Intercellular Signaling Peptides and Proteins::Cytokines::Hematopoietic Cell Growth Factors::Colony-Stimulating Factors::Granulocyte Colony-Stimulating Factor
Medical Subject Headings::Anatomy::Hemic and Immune Systems::Hematopoietic System::Bone Marrow Cells::Hematopoietic Stem Cells
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Transplantation, Autologous
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Lymphatic Diseases::Lymphoproliferative Disorders::Lymphoma
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Lymphatic Diseases::Lymphoproliferative Disorders::Lymphoma::Lymphoma, Non-Hodgkin
Medical Subject Headings::Diseases::Immune System Diseases::Immunoproliferative Disorders::Lymphoproliferative Disorders::Multiple Myeloma
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Multicenter Studies as Topic
Medical Subject Headings::Diseases::Substance-Related Disorders::Poisoning::Drug Toxicity
Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Intercellular Signaling Peptides and Proteins::Cytokines::Hematopoietic Cell Growth Factors::Colony-Stimulating Factors::Granulocyte Colony-Stimulating Factor
Medical Subject Headings::Anatomy::Hemic and Immune Systems::Hematopoietic System::Bone Marrow Cells::Hematopoietic Stem Cells
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Transplantation, Autologous
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Lymphatic Diseases::Lymphoproliferative Disorders::Lymphoma
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Lymphatic Diseases::Lymphoproliferative Disorders::Lymphoma::Lymphoma, Non-Hodgkin
Medical Subject Headings::Diseases::Immune System Diseases::Immunoproliferative Disorders::Lymphoproliferative Disorders::Multiple Myeloma
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Multicenter Studies as Topic
Medical Subject Headings::Diseases::Substance-Related Disorders::Poisoning::Drug Toxicity
DeCS Terms
CIE Terms
Keywords
Europa, Compuestos heterocíclicos, Factor estimulante de colonias de granulocitos, Células madre hematopoyéticas, Trasplante autólogo, Linfoma no Hodgkin, Mieloma múltiple, Estudios multicéntricos como asunto, Toxicidad medicamentosa
Citation
Russell N, Douglas K, Ho AD, Mohty M, Carlson K, Ossenkoppele GJ, et al. Plerixafor and granulocyte colony-stimulating factor for first-line steady-state autologous peripheral blood stem cell mobilization in lymphoma and multiple myeloma: results of the prospective PREDICT trial. Haematologica. 2013; 98(2):172-8