PERIPHERAL BLOOD HEMATOPOETIC STEM CELLS (PBSC) MOBILIZATION WITH GENERIC VERSION OF PLERIXAFOR: AN EXPERIENCE AT A NORTH INDIAN TERTIARY CARE REFERRAL INSTITUTE
(Abstract release date: 05/19/16)
EHA Library. Sahu K. 06/09/16; 135088; PB2188
Dr. Kamal Sahu
Contributions
Contributions
Abstract
Abstract: PB2188
Type: Publication Only
Background
Plerixafor is used to mobilize hematopoietic stem cells in cancer patients into the bloodstream. Developed by AnorMED, plerixafor was approved by the U.S. Food and Drug Administration (FDA) on 15 December 2008. Henceforth, Genzyme (USA based company) took a step forward and launched plerixafor from benchside to bedside. Brilliant success story of this new molecule was hindered by the expensive cost thereby debarring large population of world from the benefit of this drug. Many Indian companies (eg. Hetero and panacea pharmaceutical companies) took the challenge to curb down the cost price and have come up recently with generic version of plerixafor.For a successful outcome of Hematopoetic Stem cell transplant a minimum dose of 2x106/Kg CD34+ cells are required. Standard mobilisation procedure involves use of G-CSF or GM-CSF alone in combination with chemotherapy. Those with certain risk factors like old age, previous multiple chemotherapy regimens, radiotherapy, bone marrow involvement with disease and exposure to agents like lenalidomide etc. may not mobilise adequately. We share our experience with generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule and yet efficacious.
Aims
To study the efficacy of generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule.
Methods
Study was conducted from December 2013 to February 2016 (26 months). In total, 66 transplants were carried out (autologous= 35 and allogeneic= 31) in our institute. Generic plerixafor was used along with G-CSF for in autologous PBSCs mobilisation in 20 out of 36 instances (Multiple myeloma =7, Hodgkins lymphoma=6, Nonhodgkin’s lymphoma = 6, APML= 1).
Results
Mean age of the patients was 39.5 years (range 17-63 years) with 13 males and 7 females. Average interval from disease diagnosis to transplant interval was 18.4 months (range 6- 96 months). Number of prior chemotherapy regimens used ranged from 2-4 and 6 patients also got radiotherapy in addition. Conditioning regimens used were-(1) Inj. melphalan = 7, (2) BEAM regimen=10, (3) LACE regimen =2, (4) CY-TBI=1. Inj. Plerixafor was given in dose of 24 microgram/kg on day 4 and/or day 5 of G-CSF (10 microgram/kg/day) mobilisation depending on peripheral blood CD34+ cells (when available) and the yield of first harvest. Most of the patients (14 out of 20) required a single dose, while the remaining six needed an additional dose. Majority of patients (17 out of 20) underwent two apheresis session while two required single session. One had initial mobilisation failure with GCSF and 2 doses of plerixafor. But he subsequently mobilised successfully after 14 days with repeat GCSF and single plerixafor dose. Mean CD34+ cells obtained was 5.44 x 106 /kg (range 2.7-13.13 x 106/kg). Neutrophilic and platelet engraftment occurred on day+13 (range 10 -20 days) and day +16 (range 10-36) respectively. Median units of PRBC and Platelet (SDAP) transfused were 3 (range 0-13) and 7 (2-15) respectively. There was only one death on day +7 due to acute cardiomyopathy.
Conclusion
Generic version of plerixafor with GCSF is an effective and safe strategy to mobilise stem cells.
Session topic: E-poster
Keyword(s): CXCR4, Multiple myeloma, SDF-1/CXCR4
Type: Publication Only
Background
Plerixafor is used to mobilize hematopoietic stem cells in cancer patients into the bloodstream. Developed by AnorMED, plerixafor was approved by the U.S. Food and Drug Administration (FDA) on 15 December 2008. Henceforth, Genzyme (USA based company) took a step forward and launched plerixafor from benchside to bedside. Brilliant success story of this new molecule was hindered by the expensive cost thereby debarring large population of world from the benefit of this drug. Many Indian companies (eg. Hetero and panacea pharmaceutical companies) took the challenge to curb down the cost price and have come up recently with generic version of plerixafor.For a successful outcome of Hematopoetic Stem cell transplant a minimum dose of 2x106/Kg CD34+ cells are required. Standard mobilisation procedure involves use of G-CSF or GM-CSF alone in combination with chemotherapy. Those with certain risk factors like old age, previous multiple chemotherapy regimens, radiotherapy, bone marrow involvement with disease and exposure to agents like lenalidomide etc. may not mobilise adequately. We share our experience with generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule and yet efficacious.
Aims
To study the efficacy of generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule.
Methods
Study was conducted from December 2013 to February 2016 (26 months). In total, 66 transplants were carried out (autologous= 35 and allogeneic= 31) in our institute. Generic plerixafor was used along with G-CSF for in autologous PBSCs mobilisation in 20 out of 36 instances (Multiple myeloma =7, Hodgkins lymphoma=6, Nonhodgkin’s lymphoma = 6, APML= 1).
Results
Mean age of the patients was 39.5 years (range 17-63 years) with 13 males and 7 females. Average interval from disease diagnosis to transplant interval was 18.4 months (range 6- 96 months). Number of prior chemotherapy regimens used ranged from 2-4 and 6 patients also got radiotherapy in addition. Conditioning regimens used were-(1) Inj. melphalan = 7, (2) BEAM regimen=10, (3) LACE regimen =2, (4) CY-TBI=1. Inj. Plerixafor was given in dose of 24 microgram/kg on day 4 and/or day 5 of G-CSF (10 microgram/kg/day) mobilisation depending on peripheral blood CD34+ cells (when available) and the yield of first harvest. Most of the patients (14 out of 20) required a single dose, while the remaining six needed an additional dose. Majority of patients (17 out of 20) underwent two apheresis session while two required single session. One had initial mobilisation failure with GCSF and 2 doses of plerixafor. But he subsequently mobilised successfully after 14 days with repeat GCSF and single plerixafor dose. Mean CD34+ cells obtained was 5.44 x 106 /kg (range 2.7-13.13 x 106/kg). Neutrophilic and platelet engraftment occurred on day+13 (range 10 -20 days) and day +16 (range 10-36) respectively. Median units of PRBC and Platelet (SDAP) transfused were 3 (range 0-13) and 7 (2-15) respectively. There was only one death on day +7 due to acute cardiomyopathy.
Conclusion
Generic version of plerixafor with GCSF is an effective and safe strategy to mobilise stem cells.
Session topic: E-poster
Keyword(s): CXCR4, Multiple myeloma, SDF-1/CXCR4
Abstract: PB2188
Type: Publication Only
Background
Plerixafor is used to mobilize hematopoietic stem cells in cancer patients into the bloodstream. Developed by AnorMED, plerixafor was approved by the U.S. Food and Drug Administration (FDA) on 15 December 2008. Henceforth, Genzyme (USA based company) took a step forward and launched plerixafor from benchside to bedside. Brilliant success story of this new molecule was hindered by the expensive cost thereby debarring large population of world from the benefit of this drug. Many Indian companies (eg. Hetero and panacea pharmaceutical companies) took the challenge to curb down the cost price and have come up recently with generic version of plerixafor.For a successful outcome of Hematopoetic Stem cell transplant a minimum dose of 2x106/Kg CD34+ cells are required. Standard mobilisation procedure involves use of G-CSF or GM-CSF alone in combination with chemotherapy. Those with certain risk factors like old age, previous multiple chemotherapy regimens, radiotherapy, bone marrow involvement with disease and exposure to agents like lenalidomide etc. may not mobilise adequately. We share our experience with generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule and yet efficacious.
Aims
To study the efficacy of generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule.
Methods
Study was conducted from December 2013 to February 2016 (26 months). In total, 66 transplants were carried out (autologous= 35 and allogeneic= 31) in our institute. Generic plerixafor was used along with G-CSF for in autologous PBSCs mobilisation in 20 out of 36 instances (Multiple myeloma =7, Hodgkins lymphoma=6, Nonhodgkin’s lymphoma = 6, APML= 1).
Results
Mean age of the patients was 39.5 years (range 17-63 years) with 13 males and 7 females. Average interval from disease diagnosis to transplant interval was 18.4 months (range 6- 96 months). Number of prior chemotherapy regimens used ranged from 2-4 and 6 patients also got radiotherapy in addition. Conditioning regimens used were-(1) Inj. melphalan = 7, (2) BEAM regimen=10, (3) LACE regimen =2, (4) CY-TBI=1. Inj. Plerixafor was given in dose of 24 microgram/kg on day 4 and/or day 5 of G-CSF (10 microgram/kg/day) mobilisation depending on peripheral blood CD34+ cells (when available) and the yield of first harvest. Most of the patients (14 out of 20) required a single dose, while the remaining six needed an additional dose. Majority of patients (17 out of 20) underwent two apheresis session while two required single session. One had initial mobilisation failure with GCSF and 2 doses of plerixafor. But he subsequently mobilised successfully after 14 days with repeat GCSF and single plerixafor dose. Mean CD34+ cells obtained was 5.44 x 106 /kg (range 2.7-13.13 x 106/kg). Neutrophilic and platelet engraftment occurred on day+13 (range 10 -20 days) and day +16 (range 10-36) respectively. Median units of PRBC and Platelet (SDAP) transfused were 3 (range 0-13) and 7 (2-15) respectively. There was only one death on day +7 due to acute cardiomyopathy.
Conclusion
Generic version of plerixafor with GCSF is an effective and safe strategy to mobilise stem cells.
Session topic: E-poster
Keyword(s): CXCR4, Multiple myeloma, SDF-1/CXCR4
Type: Publication Only
Background
Plerixafor is used to mobilize hematopoietic stem cells in cancer patients into the bloodstream. Developed by AnorMED, plerixafor was approved by the U.S. Food and Drug Administration (FDA) on 15 December 2008. Henceforth, Genzyme (USA based company) took a step forward and launched plerixafor from benchside to bedside. Brilliant success story of this new molecule was hindered by the expensive cost thereby debarring large population of world from the benefit of this drug. Many Indian companies (eg. Hetero and panacea pharmaceutical companies) took the challenge to curb down the cost price and have come up recently with generic version of plerixafor.For a successful outcome of Hematopoetic Stem cell transplant a minimum dose of 2x106/Kg CD34+ cells are required. Standard mobilisation procedure involves use of G-CSF or GM-CSF alone in combination with chemotherapy. Those with certain risk factors like old age, previous multiple chemotherapy regimens, radiotherapy, bone marrow involvement with disease and exposure to agents like lenalidomide etc. may not mobilise adequately. We share our experience with generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule and yet efficacious.
Aims
To study the efficacy of generic plerixafor which is approximately 4-4.5 times cheaper than the original molecule.
Methods
Study was conducted from December 2013 to February 2016 (26 months). In total, 66 transplants were carried out (autologous= 35 and allogeneic= 31) in our institute. Generic plerixafor was used along with G-CSF for in autologous PBSCs mobilisation in 20 out of 36 instances (Multiple myeloma =7, Hodgkins lymphoma=6, Nonhodgkin’s lymphoma = 6, APML= 1).
Results
Mean age of the patients was 39.5 years (range 17-63 years) with 13 males and 7 females. Average interval from disease diagnosis to transplant interval was 18.4 months (range 6- 96 months). Number of prior chemotherapy regimens used ranged from 2-4 and 6 patients also got radiotherapy in addition. Conditioning regimens used were-(1) Inj. melphalan = 7, (2) BEAM regimen=10, (3) LACE regimen =2, (4) CY-TBI=1. Inj. Plerixafor was given in dose of 24 microgram/kg on day 4 and/or day 5 of G-CSF (10 microgram/kg/day) mobilisation depending on peripheral blood CD34+ cells (when available) and the yield of first harvest. Most of the patients (14 out of 20) required a single dose, while the remaining six needed an additional dose. Majority of patients (17 out of 20) underwent two apheresis session while two required single session. One had initial mobilisation failure with GCSF and 2 doses of plerixafor. But he subsequently mobilised successfully after 14 days with repeat GCSF and single plerixafor dose. Mean CD34+ cells obtained was 5.44 x 106 /kg (range 2.7-13.13 x 106/kg). Neutrophilic and platelet engraftment occurred on day+13 (range 10 -20 days) and day +16 (range 10-36) respectively. Median units of PRBC and Platelet (SDAP) transfused were 3 (range 0-13) and 7 (2-15) respectively. There was only one death on day +7 due to acute cardiomyopathy.
Conclusion
Generic version of plerixafor with GCSF is an effective and safe strategy to mobilise stem cells.
Session topic: E-poster
Keyword(s): CXCR4, Multiple myeloma, SDF-1/CXCR4
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