OUTPATIENT STEM CELL MOBILIZATION WITH INTERMEDIATE-DOSE CYCLOPHOSPHAMIDE IS A SAFE AND EFFECTIVE PROCEDURE
(Abstract release date: 05/19/16)
EHA Library. Pompa A. 06/09/16; 134855; PB1955
Dr. Alessandra Pompa
Contributions
Contributions
Abstract
Abstract: PB1955
Type: Publication Only
Background
Autologous stem cell transplantation (ASCT), even in the era of new drugs, is the treatment of choice in younger and fit Multiple Myeloma (MM) patients. Cyclophosphamide (CY) at different doses has been shown to be an effective regimen for collecting peripheral blood stem cells (PBSC) in MM. Clinical trials have demonstrated that intermediate dose CY (3 and 4 g/m2, ID-CY) combined with G-CSF, is an efficient mobilizing regimen with less toxicity compared with high dose CY (7 g/m2, HD-CY) in term of neutrophil recovery, thrombocytopenia, need of transfusions and IV antibiotics. (Goldschmidt, BMT 1996; Fitoussi, BMT 2001). The method used for PBSC mobilization has not been shown to affect overall transplantation outcomes (Kumar, Blood 2009). Mobilization therapy is usually administered in an inpatient regimen, for the concern of toxicity.
Aims
Our purpose is to evaluate the safety of mobilization therapy administered in an outpatient regimen, with the prospect to lower costs and minimize patient inconvenience, maintaining an optimal yield.
Methods
One hundred patients with newly diagnosed MM underwent outpatient stem cell mobilization with CY 3 g/m2 (80%) or 4 g/m2 (20%) + G-CSF after induction therapy with VEL-based (81%) or VAD (19%) regimens. G-CSF 10 mcg/Kg was started by day +5 and continued until completion of apheresis. No antibiotics prophylaxis was routinely used. Day 0 was defined as the CY infusion day. CY was administered in 2-4 consecutive 1h infusions (depending on total dose). Hyper-hydration (3.5/4 l), antiemetics and the uroprotectant Uromitexan were began IV 1 hour before CY infusion. Subsequently, Uromitexan was continued at home orally in the next 12h. Furthermore, the patient was advised to drink 2.5/3 l of water in the next 24h. Blood count was monitored at day + 4 and daily from day +7. CD34+ cells were counted on peripheral blood by day 7; apheresis was started at leukocyte rise and with a value of at least 20 CD34+/μl. Number of apheresis depended on the number of CD34+ cells collected to obtain al least 4x106 CD34+/Kg. Stem cells were then manipulated and cryopreserved with standard techniques.
Results
Results are actually available for 88 of these patients. Median age at mobilization therapy was 57y (range 34-68). Response prior of mobilization was CR/sCR in 18%, VGPR in 52%, PR in 27%, and PD in 3%. Chemotherapy was very well tolerated. Most frequently observed adverse events (AEs) were nausea and vomiting of grade 1-2. Two patients experienced cystitis (one grade 1, one grade 2), 2 patients fever and infections. Only one patient required hospitalization for AEs for fever without microbiological findings, rapidly regressed with IV antibiotics. There were no other significant AEs related to chemotherapy. All patients proceeded to stem cell harvest and reached CD34+ target, but 7 patients required administration of Plerixafor on demand. After mobilization, 85 patients proceeded to ASCT.
Conclusion
In conclusion, outpatient mobilization with ID-CY appears to be an efficient and safe procedure, with minimal and manageable side effects and low rate of hospitalization. Outpatient mobilization could ameliorate the quality of life of patients and reduce costs, avoiding or minimizing the hospitalization rate, without compromising the safety profile and the success of PBSC collect.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Myeloma, Safety
Type: Publication Only
Background
Autologous stem cell transplantation (ASCT), even in the era of new drugs, is the treatment of choice in younger and fit Multiple Myeloma (MM) patients. Cyclophosphamide (CY) at different doses has been shown to be an effective regimen for collecting peripheral blood stem cells (PBSC) in MM. Clinical trials have demonstrated that intermediate dose CY (3 and 4 g/m2, ID-CY) combined with G-CSF, is an efficient mobilizing regimen with less toxicity compared with high dose CY (7 g/m2, HD-CY) in term of neutrophil recovery, thrombocytopenia, need of transfusions and IV antibiotics. (Goldschmidt, BMT 1996; Fitoussi, BMT 2001). The method used for PBSC mobilization has not been shown to affect overall transplantation outcomes (Kumar, Blood 2009). Mobilization therapy is usually administered in an inpatient regimen, for the concern of toxicity.
Aims
Our purpose is to evaluate the safety of mobilization therapy administered in an outpatient regimen, with the prospect to lower costs and minimize patient inconvenience, maintaining an optimal yield.
Methods
One hundred patients with newly diagnosed MM underwent outpatient stem cell mobilization with CY 3 g/m2 (80%) or 4 g/m2 (20%) + G-CSF after induction therapy with VEL-based (81%) or VAD (19%) regimens. G-CSF 10 mcg/Kg was started by day +5 and continued until completion of apheresis. No antibiotics prophylaxis was routinely used. Day 0 was defined as the CY infusion day. CY was administered in 2-4 consecutive 1h infusions (depending on total dose). Hyper-hydration (3.5/4 l), antiemetics and the uroprotectant Uromitexan were began IV 1 hour before CY infusion. Subsequently, Uromitexan was continued at home orally in the next 12h. Furthermore, the patient was advised to drink 2.5/3 l of water in the next 24h. Blood count was monitored at day + 4 and daily from day +7. CD34+ cells were counted on peripheral blood by day 7; apheresis was started at leukocyte rise and with a value of at least 20 CD34+/μl. Number of apheresis depended on the number of CD34+ cells collected to obtain al least 4x106 CD34+/Kg. Stem cells were then manipulated and cryopreserved with standard techniques.
Results
Results are actually available for 88 of these patients. Median age at mobilization therapy was 57y (range 34-68). Response prior of mobilization was CR/sCR in 18%, VGPR in 52%, PR in 27%, and PD in 3%. Chemotherapy was very well tolerated. Most frequently observed adverse events (AEs) were nausea and vomiting of grade 1-2. Two patients experienced cystitis (one grade 1, one grade 2), 2 patients fever and infections. Only one patient required hospitalization for AEs for fever without microbiological findings, rapidly regressed with IV antibiotics. There were no other significant AEs related to chemotherapy. All patients proceeded to stem cell harvest and reached CD34+ target, but 7 patients required administration of Plerixafor on demand. After mobilization, 85 patients proceeded to ASCT.
Conclusion
In conclusion, outpatient mobilization with ID-CY appears to be an efficient and safe procedure, with minimal and manageable side effects and low rate of hospitalization. Outpatient mobilization could ameliorate the quality of life of patients and reduce costs, avoiding or minimizing the hospitalization rate, without compromising the safety profile and the success of PBSC collect.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Myeloma, Safety
Abstract: PB1955
Type: Publication Only
Background
Autologous stem cell transplantation (ASCT), even in the era of new drugs, is the treatment of choice in younger and fit Multiple Myeloma (MM) patients. Cyclophosphamide (CY) at different doses has been shown to be an effective regimen for collecting peripheral blood stem cells (PBSC) in MM. Clinical trials have demonstrated that intermediate dose CY (3 and 4 g/m2, ID-CY) combined with G-CSF, is an efficient mobilizing regimen with less toxicity compared with high dose CY (7 g/m2, HD-CY) in term of neutrophil recovery, thrombocytopenia, need of transfusions and IV antibiotics. (Goldschmidt, BMT 1996; Fitoussi, BMT 2001). The method used for PBSC mobilization has not been shown to affect overall transplantation outcomes (Kumar, Blood 2009). Mobilization therapy is usually administered in an inpatient regimen, for the concern of toxicity.
Aims
Our purpose is to evaluate the safety of mobilization therapy administered in an outpatient regimen, with the prospect to lower costs and minimize patient inconvenience, maintaining an optimal yield.
Methods
One hundred patients with newly diagnosed MM underwent outpatient stem cell mobilization with CY 3 g/m2 (80%) or 4 g/m2 (20%) + G-CSF after induction therapy with VEL-based (81%) or VAD (19%) regimens. G-CSF 10 mcg/Kg was started by day +5 and continued until completion of apheresis. No antibiotics prophylaxis was routinely used. Day 0 was defined as the CY infusion day. CY was administered in 2-4 consecutive 1h infusions (depending on total dose). Hyper-hydration (3.5/4 l), antiemetics and the uroprotectant Uromitexan were began IV 1 hour before CY infusion. Subsequently, Uromitexan was continued at home orally in the next 12h. Furthermore, the patient was advised to drink 2.5/3 l of water in the next 24h. Blood count was monitored at day + 4 and daily from day +7. CD34+ cells were counted on peripheral blood by day 7; apheresis was started at leukocyte rise and with a value of at least 20 CD34+/μl. Number of apheresis depended on the number of CD34+ cells collected to obtain al least 4x106 CD34+/Kg. Stem cells were then manipulated and cryopreserved with standard techniques.
Results
Results are actually available for 88 of these patients. Median age at mobilization therapy was 57y (range 34-68). Response prior of mobilization was CR/sCR in 18%, VGPR in 52%, PR in 27%, and PD in 3%. Chemotherapy was very well tolerated. Most frequently observed adverse events (AEs) were nausea and vomiting of grade 1-2. Two patients experienced cystitis (one grade 1, one grade 2), 2 patients fever and infections. Only one patient required hospitalization for AEs for fever without microbiological findings, rapidly regressed with IV antibiotics. There were no other significant AEs related to chemotherapy. All patients proceeded to stem cell harvest and reached CD34+ target, but 7 patients required administration of Plerixafor on demand. After mobilization, 85 patients proceeded to ASCT.
Conclusion
In conclusion, outpatient mobilization with ID-CY appears to be an efficient and safe procedure, with minimal and manageable side effects and low rate of hospitalization. Outpatient mobilization could ameliorate the quality of life of patients and reduce costs, avoiding or minimizing the hospitalization rate, without compromising the safety profile and the success of PBSC collect.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Myeloma, Safety
Type: Publication Only
Background
Autologous stem cell transplantation (ASCT), even in the era of new drugs, is the treatment of choice in younger and fit Multiple Myeloma (MM) patients. Cyclophosphamide (CY) at different doses has been shown to be an effective regimen for collecting peripheral blood stem cells (PBSC) in MM. Clinical trials have demonstrated that intermediate dose CY (3 and 4 g/m2, ID-CY) combined with G-CSF, is an efficient mobilizing regimen with less toxicity compared with high dose CY (7 g/m2, HD-CY) in term of neutrophil recovery, thrombocytopenia, need of transfusions and IV antibiotics. (Goldschmidt, BMT 1996; Fitoussi, BMT 2001). The method used for PBSC mobilization has not been shown to affect overall transplantation outcomes (Kumar, Blood 2009). Mobilization therapy is usually administered in an inpatient regimen, for the concern of toxicity.
Aims
Our purpose is to evaluate the safety of mobilization therapy administered in an outpatient regimen, with the prospect to lower costs and minimize patient inconvenience, maintaining an optimal yield.
Methods
One hundred patients with newly diagnosed MM underwent outpatient stem cell mobilization with CY 3 g/m2 (80%) or 4 g/m2 (20%) + G-CSF after induction therapy with VEL-based (81%) or VAD (19%) regimens. G-CSF 10 mcg/Kg was started by day +5 and continued until completion of apheresis. No antibiotics prophylaxis was routinely used. Day 0 was defined as the CY infusion day. CY was administered in 2-4 consecutive 1h infusions (depending on total dose). Hyper-hydration (3.5/4 l), antiemetics and the uroprotectant Uromitexan were began IV 1 hour before CY infusion. Subsequently, Uromitexan was continued at home orally in the next 12h. Furthermore, the patient was advised to drink 2.5/3 l of water in the next 24h. Blood count was monitored at day + 4 and daily from day +7. CD34+ cells were counted on peripheral blood by day 7; apheresis was started at leukocyte rise and with a value of at least 20 CD34+/μl. Number of apheresis depended on the number of CD34+ cells collected to obtain al least 4x106 CD34+/Kg. Stem cells were then manipulated and cryopreserved with standard techniques.
Results
Results are actually available for 88 of these patients. Median age at mobilization therapy was 57y (range 34-68). Response prior of mobilization was CR/sCR in 18%, VGPR in 52%, PR in 27%, and PD in 3%. Chemotherapy was very well tolerated. Most frequently observed adverse events (AEs) were nausea and vomiting of grade 1-2. Two patients experienced cystitis (one grade 1, one grade 2), 2 patients fever and infections. Only one patient required hospitalization for AEs for fever without microbiological findings, rapidly regressed with IV antibiotics. There were no other significant AEs related to chemotherapy. All patients proceeded to stem cell harvest and reached CD34+ target, but 7 patients required administration of Plerixafor on demand. After mobilization, 85 patients proceeded to ASCT.
Conclusion
In conclusion, outpatient mobilization with ID-CY appears to be an efficient and safe procedure, with minimal and manageable side effects and low rate of hospitalization. Outpatient mobilization could ameliorate the quality of life of patients and reduce costs, avoiding or minimizing the hospitalization rate, without compromising the safety profile and the success of PBSC collect.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Myeloma, Safety
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