Results and Cost Effectiveness of "on-Demand" Plerixafor Added to Chemotherapy and Granulocyte Colony-Stimulating Factor for Peripheral Blood Stem Cell Mobilization in Multiple Myeloma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4305-4305
Author(s):  
Giuseppe Milone ◽  
Massimo Martino ◽  
Annalia Di Marco ◽  
Salvatore Leotta ◽  
Andrea Spadaro ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
High Dose Chemotherapy ◽  
Control Group ◽  
High Dose ◽  
On Demand ◽  
Cd34 Cells ◽  
Optimal Harvest ◽  
Increase In Probability ◽  
Cell Mobilization ◽  
Pbsc Mobilization

Abstract The failure of peripheral blood stem cell (PBSC) mobilization and harvest is a critical issue for multiple myeloma (MM) patients undergoing high-dose chemotherapy. Plerixafor (PLX) is an effective mobilizing agent; however, its use for every MM patient undergoing high-dose chemotherapy has led to a notable increase in costs. We designed a highly specific and sensitive algorithm for identifying patients likely to fail PBSC mobilization after chemotherapy and G-CSF (Blood Transfusion 2013.11:94). The use of this algorithm thereby allows selective administration of PLX to patients predicted to fail mobilization after chemotherapy and G-CSF (on-demand PLX) and may reduce failure rate of PBSC mobilization while limiting cost. We performed a multicenter phase II prospective study of on-demand PLX used according to our algorithm for patients with lymphoma or MM, who were mobilized by cyclophosphamide and G-CSF. The study was powered to demonstrate a reduction in mobilization failure from 14% to 7% for the entire population of treated patients. Here, we report the final results for MM patients. The inclusion criteria for MM patients were as follows: diagnosis of symptomatic MM, age 18-70 yr, achievement of any response after first-line treatment administered for 4-8 months, first mobilization attempt, cardiac and pulmonary function adequate for high-dose chemotherapy. Mobilization schedule was cyclophosphamide (CTX, 4 g/m2) and G-CSF (5-10 mcg/Kg), PLX (240 mcg/Kg) was administered only to patients selected by the algorithm. Estimation of costs was performed according to a previously reported study (BJH 2014, 164, 113). There were 111 patients with MM who underwent treatment. Successful CD34+ cell mobilization (>20×109 cells/mL in PB) was achieved for 97.2% (108/111) of patients, and failure of mobilization occurred in the remaining 3 (2.8%); minimal apheretic harvest success (>2.0×106 CD34+ cells/Kg) was achieved for 97.2% (108/111); and optimal harvest success (=/>4.0×106 CD34+ cells/Kg) was achieved for 84.6% (94/111). On-demand PLX was needed for 8.2% of patients (9/111). After autologous hematopoietic transplantation, neutrophil (N) engraftment (N>0.5x109 cells/L) was reached at day +11.8 (range day +8 to +24). We compared these prospective results with the mobilization results obtained retrospectively in a control group of 183 MM patients who received the same mobilization schedule without PLX. After the two groups were adjusted for unbalanced factors, multivariable logistic regression analysis revealed that on-demand PLX treatment according to the algorithm led to significant increases in the probabilities of achieving a successful minimal apheretic harvest (p=0.006; hazard ratio [HR] 5.624, 95% confidence interval [CI] 1.168-19.548) and optimal harvest (p=0.02; HR 2.121, 95% CI 1.118-4.025). The mean cost increase for the first mobilization in the PLX-on-demand prospective study, in respect to control group, was 615 €/patient. The incremental cost-effectiveness ratio (ICER) was calculated as: (cost1-cost2)/(result1-result2). ICER was 47 €/1% increase in probability of a minimal apheretic harvest while it was 68 €/1% increase in probability of an optimal apheretic harvest. In conclusion, the final analysis of our study found that on-demand PLX for MM patients, which was added to the mobilization schedule of CTX (4 g/m2) + G-CSF (5-10 mcg/Kg), allowed a successful harvest from the first mobilization treatment in > 97% of patients, with 85% of patients achieving a harvest sufficient for two rounds of high-dose chemotherapy. These results indicate that on-demand PLX added to mobilization chemotherapy is a significant improvement over the same type of mobilization chemotherapy without PLX. The limited use of PLX in this study allowed for a favorable incremental cost-effectiveness ratio of this expensive agent. On-demand PLX used according to a validated algorithm in addition to CTX plus G-CSF may be considered a new standard for PBSC mobilization and harvest in patients with MM. Table 1.Failure of CD34+ Mobilization in PB Failure of Minimal Harvest Failure of Optimal Harvest Cost per PatientICER (Minimal Harvest)ICER (Optimal Harvest)PLX on Demand (n 111)2.8%2.8%15.4%3,969 €47 €/ 1% increase in probability of a Minimal Harvest68 €/ 1% increase in probability of an Optimal HarvestControl Cohort (n 183)7.6%15.8%24.4%3,354 €P (adjusted for comparisons)NS0.0060.02 Disclosures Milone: Sanofi: Consultancy. Martino:Sanofi: Consultancy. Olivieri:Sanofi: Consultancy.

Plerixafor On Demand Associated With Chemotherapy and G-CSF: Interim Analysis Of a Prospective Study Shows Significant Improvement In PBSC Mobilization and Harvest With No Increase In Costs

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4509-4509
Author(s):  
Giuseppe Milone ◽  
Massimo Martino ◽  
Potito R Scalzulli ◽  
Andrea Spadaro ◽  
Valentina Di Martina ◽  
...  
Keyword(s):  
Prospective Study ◽  
Predictive Value ◽  
Interim Analysis ◽  
Conflicts Of Interest ◽  
Historical Control ◽  
Control Group ◽  
High Dose ◽  
Drug Shortage ◽  
On Demand ◽  
Cd34 Cells

Background To date, no prospective study on Plerixafor “on demand” in association with chemotherapy and G-CSF has been reported. Methods We present an interim analysis of the first prospective study in which Plerixafor (PLX) was administered “on demand”, according to a specific algorithm, in patients affected by Multiple Myeloma and Lymphoma who received high dose Cyclophosphamide (4g/m2) or DHAP plus G-CSF to mobilize PBSC. Algorithm was developed after a retrospective study done in our Institution (Blood Transfusion, 11(1):94). One hundred and twelve patients were registered in this prospective study, 111 patients were assessable for requirement of on demand PLX, 102 patients were evaluable for mobilization efficacy of“ PLX on demand” strategy, (72 patients were affected by MM and 30 by Lymphoma). A set of 240 patients receiving the same mobilizing chemotherapy (DHAP or CTX 4 gr/sqm) plus G-CSF were retrospectively studied for comparison. Results PLX requirement, overall, was 14.4% (16/111). PLX requirement was 21.6% in Lymphoma patients and 10.6% in MM patients (p=0.010). Failure to mobilize CD34+ cells in PB (CD34+ peak in PB < 20 x 10^6/l) was reduced by “on demand” strategy compared to conventional mobilization; from 13.0% to 3.0% (p=0.004). Failure to harvest CD34+cells (CD34+< 2x10^6/Kg) decreased from 20.9% to 4.0% (p=0.0001). Second mobilization rate in the “on demand” strategy compared to conventional mobilization decreased from 14.3% to 3.0% (p=0.03). In lymphoma stratum the “on demand strategy” resulted in a successful mobilization in 96.6% while the historical control group had a mobilization successful rate of 73.2% (p=0.007); in the MM stratum the “on demand strategy” was successful in 97.2% while the historical control had a mobilization success of 91.3% (p=0.09). Negative Predictive Value (NPV) of the algorithm was determined in patients treated in the “on demand study” by evaluating the subgroup of patients who received the planned mobilization and did not receive PLX because, according to the algorithm, its use was not indicated. 93 patients were assessable, 93/93 had a successful mobilization (CD34+ in PB > 20x10^6/l), thus NPV was 100%. Positive Predictive Value (PPV) of algorithm was determined in the subgroup of patients who were not treated because of drug shortage although the use of PLX was indicated (n 6). PPV was 83.4%. Of the 10 patients where PLX use was indicated and who received at least one dose, a successful mobilization was reached in 70% (7/10) of cases and a successful harvest in 66.6% (6/10). We estimated the cost of mobilizing and harvesting 100 patients affected by Lymphoma or Myeloma by either conventional mobilization based on chemotherapy plus G-CSF or by the PLX on demand strategy. Sum of cost of first mobilizations and of salvage mobilizations (required in patients failing the first mobilization attempt) were calculated in the two different mobilization strategies. Cost to mobilize 100 Myeloma patients was: 465,648 euros for conventional mobilization versus 423,816 euros for “on demand PLX” strategy; cost to mobilize 100 Lymphoma patients was 552,480 euros in conventional strategy versus 537,912 for “on demand PLX” strategy. Conclusion In association with CTX or DHAP plus G-CSF, the “on demand” use of Plerixafor in patients selected by our algorithm showed a significant improvement in mobilization of CD34+ cells and in harvest of PBSC with no increase in overall costs. Disclosures: No relevant conflicts of interest to declare.

Autologous transplantation of granulocyte colony-stimulating factor–primed bone marrow is effective in supporting myeloablative chemotherapy in patients with hematologic malignancies and poor peripheral blood stem cell mobilization

Blood ◽  
2003 ◽  
Vol 102 (5) ◽  
pp. 1595-1600 ◽  
Author(s):  
Roberto M. Lemoli ◽  
Antonio de Vivo ◽  
Daniela Damiani ◽  
Alessandro Isidori ◽  
Monica Tani ◽  
...  
Keyword(s):  
Stem Cell ◽  
Peripheral Blood Stem Cell ◽  
High Dose Chemotherapy ◽  
Stem Cell Mobilization ◽  
High Dose ◽  
Myeloablative Chemotherapy ◽  
Hematopoietic Recovery ◽  
Cd34 Cells ◽  
Cell Mobilization ◽  
Stimulating Factor

AbstractWe assessed the hematopoietic recovery and transplantation-related mortality (TRM) of patients who had failed peripheral blood stem cell mobilization and subsequently received high-dose chemotherapy supported by granulocyte colony-stimulating factor (G-CSF)–primed bone marrow (BM). Studied were 86 heavily pretreated consecutive patients with acute leukemia (n = 21), refractory/relapsed non-Hodgkin lymphoma (n = 41) and Hodgkin disease (n = 17), and multiple myeloma (n = 7). There were 78 patients who showed insufficient mobilization of CD34+ cells (&lt; 10 cells/μL), whereas 8 patients collected less than 1 × 106 CD34+ cells/kg. BM was primed in vivo for 3 days with 15 to 16 μg/kg of subcutaneous G-CSF. Median numbers of nucleated cells, colony-forming unit cells (CFU-Cs), and CD34+ cells per kilogram harvested were 3.5 × 108, 3.72 × 104, and 0.82 × 106, respectively. Following myeloablative chemotherapy, median times to achieve a granulocyte count higher than 0.5 × 109/L and an unsupported platelet count higher than 20 and 50 × 109/L were 13 (range, 8-24), 15 (range, 12-75), and 22 (range, 12-180) days, respectively, for lymphoma/myeloma patients and 23 (range, 13-53), 52 (range, 40-120), and 90 (range, 46-207) days, respectively, for leukemia patients. Median times to hospital discharge after transplantation were 17 (range, 12-40) and 27 (range, 14-39) days for lymphoma/myeloma and acute leukemia patients, respectively. TRM was 4.6%, whereas 15 patients died of disease. G-CSF–primed BM induces effective multilineage hematopoietic recovery after high-dose chemotherapy and can be safely used in patients with poor stem cell mobilization.

scholarly journals Chemotherapy-based versus chemotherapy-free stem cell mobilization (± plerixafor) in multiple myeloma patients: an Italian cost-effectiveness analysis

2021 ◽  
Author(s):  
Carlo Lazzaro ◽  
Luca Castagna ◽  
Francesco Lanza ◽  
Daniele Laszlo ◽  
Giuseppe Milone ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Cost Effectiveness ◽  
Cost Effectiveness Analysis ◽  
Hematopoietic Progenitor Cell ◽  
Base Case ◽  
High Dose ◽  
On Demand ◽  
Effectiveness Analysis ◽  
Cell Mobilization ◽  
The Cost

AbstractGiven the availability and efficacy of the mobilizing agent plerixafor in augmenting hematopoietic progenitor cell mobilization with granulocyte colony-stimulating factor (G-CSF), there is a strong case for comparing the cost-effectiveness of mobilization with G-CSF + cyclophosphamide versus G-CSF alone. This study investigated the cost and effectiveness (i.e., successful 4 million-CD34+ collection) of G-CSF alone versus high-dose cyclophosphamide (4 g/m2) + G-CSF mobilization (± on-demand plerixafor) in patients with multiple myeloma (MM) eligible for autograft in Italy. A decision tree-supported cost-effectiveness analysis (CEA) model in MM patients was developed from the societal perspective. The CEA model compared G-CSF alone with cyclophosphamide 4 g/m2 + G-CSF (± on-demand plerixafor) and was populated with demographic, healthcare and non-healthcare resource utilization data collected from a questionnaire administered to six Italian oncohematologists. Costs were expressed in Euro (€) 2019. The CEA model showed that G-CSF alone was strongly dominant versus cyclophosphamide + G-CSF ( ± on-demand plerixafor), with incremental savings of €1198.59 and an incremental probability of a successful 4 million-CD34+ apheresis (+0.052). Sensitivity analyses confirmed the robustness of the base-case results. In conclusion, chemotherapy-free mobilization (± on-demand plerixafor) is a “good value for money” option for MM patients eligible for autograft.

scholarly journals Peripheral Blood Progenitor Cell Mobilization of CD34+ Cells with Combine G-CSF and GM-CSF in Pediatric Patient Outcome and Economic Advantage

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 22-22
Author(s):  
Heidy lyz Garcia
Keyword(s):  
Conflicts Of Interest ◽  
Cost Effective ◽  
High Dose Chemotherapy ◽  
Economic Advantage ◽  
Hematological Toxicity ◽  
High Dose ◽  
Gm Csf ◽  
Cd34 Cells ◽  
Stems Cells ◽  
Cell Mobilization

Background: Clinical trials to mobilize PBPC for autologous and allogeneic harvesting prior to high dose chemotherapy/radiotherapy include chemotherapy, cytokines, or chemotherapy combine with cytokines. PBPC mobilized by G-CSF or GM-CSF reduces the hematological toxicity and supportive care requirements in recipients of autologous and allogeneic transplants, in our study we combined G-CSF and GM-CSF to mobilize PBPC for transplantation. Methods: We selected 63 patients with different cancers to participate in the study and 7 healthy donors. We utilize to mobilize in all the patient the combination of G-CSF and GM-CSF (10μg/Kg/day each) administered for 5 consecutive days. Then we proceed it to harvest the PBPC until we obtain a threshold of 2.0 x 10^6/Kg CD34+ cells. A total of 31 PBPC transplants were performed (27 autologous and 8 allogeneic). Neutrophil engraftment was defined as ANC&gt; 500/mm³ and, platelet engraftment was defined as a platelet count &gt; 30,000/mm³ (transfusion independent) for more than 48 hours. Results: Data on PBC 24, 48, 72, and 96hrs. For the 31 PBPC autologous transplant patients, the median days to ANC&gt;500 was 10.6 days; 11 days for the allogeneic. None of the subject's experience bone pain, headache, flu like side effects or a documented or proven infection. Median days to platelet engraftment following infusion CD34+ cells, was 13.2 for the autologous PBPC; 13 days for the allogeneic. Conclusions: The combination the G-CSF and GM-CSF (10μg/kg/day x 5 days) was well tolerated. We can appreciate that there is a reduction in the duration and severity of neutropenia as well of thrombocytopenia in both types of transplant (autologous/allogeneic). The GVHD incidence were not increase by the use of G-CSF and GM-CSF. We conclude that this procedure is cost effective and a suitable way to mobilize an average number of PBPC (from 1-3 apheresis) in a shorter amount of time indicating an economic advantage. It is proven to be less expensive than other agent used to mobilize stems cells for transplant. Disclosures No relevant conflicts of interest to declare.

The Cost-Effectiveness of Plerixafor Plus G-CSF for Stem Cell Mobilization In Patients with Diffuse Large B-Cell Non-Hodgkin Lymphoma

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4738-4738
Author(s):  
Steven Kymes ◽  
Martin Gregory ◽  
Dennis Lambert ◽  
Kenneth R. Carson ◽  
Iskra Pusic ◽  
...  
Keyword(s):  
Stem Cell ◽  
Cost Effectiveness ◽  
Research Funding ◽  
High Dose Chemotherapy ◽  
Cost Utility ◽  
Stem Cell Mobilization ◽  
High Dose ◽  
First Line ◽  
Cell Mobilization ◽  
The Cost

Abstract Abstract 4738 Introduction: High-dose chemotherapy in conjunction with autologous peripheral stem cell transplantation (ASCT) has emerged as a preferred treatment modality for a variety of relapsed hematological malignancies including non-Hodgkin lymphoma (NHL). Failure rates with current mobilization regimens are estimated to be between 5% and 30%. This failure adds substantially to the cost of this already costly procedure due to the need for multiple apheresis sessions following initial mobilization, as well as the implementation of costly rescue protocols. An additional economic burden of this reduced efficacy is increased mortality as fewer patients proceed to transplantation. Plerixafor with G-CSF (G+P) has been shown to be superior to G-CSF (G) alone for stem cell mobilization in heavily pretreated patients with NHL. This increased efficacy reduces the required number of apheresis sessions, reduces the likelihood of rescue, and increases the likelihood of successful engraftment, all of which increases the societal value of plerixafor for this indication. We conducted an economic evaluation of the cost-utility of the G+P as a first line treatment for stem cell mobilization in patients with DLCL versus G alone. Methods: Data from a number of sources were used to construct a decision analytic model to replicate the series of events experienced by a patient undergoing high dose chemotherapy treatment for DLCL, including stem cell mobilization, apheresis, and ASCT. Data from the Washington University site of the plerixafor Phase III study for patients with DLCL (n=20) were used to model the process of stem cell mobilization and apheresis. The probability of mortality post ASCT was taken from the literature. Costs in the model were based upon the Medicare allowable for that service or medication; utilities were taken from the peer reviewed literature. The incremental cost-utility ratio (ICUR) was estimated from a societal perspective with a time horizon of the patient's remaining lifetime using a microsimulation approach. Results: 100% (10/10) patients receiving P+G as their first line therapy proceeded to ASCT, while 70% (7/10) of patients receiving G as first line therapy proceeded to ASCT. Patients who did not proceed to transplant were assumed to not contribute any cost or QALYs to the final model result during or after transplant. The expected lifetime cost of providing care for NHL for a person on the P+G treatment was $25,567 more than the G regimen, but they also accumulated 1.74 more quality adjusted life years (QALYs) for an ICUR of $14,735/QALY, due to the greater probability of undergoing transplant. This is well under the willingness to pay of $50,000/QALY accepted in many industrialized nations. In sensitivity analyses we found that this standard of cost-effectiveness was met so long as the probability of transplant was greater than 77%. Conclusion: The use of plerixafor plus G-CSF for stem cell mobilization in ASCT of patients with DLCL meets most accepted standards of cost-effectiveness. This economic benefit is largely the result of the effectiveness of the P+G regimen in insuring that patients achieve sufficient cell counts to achieve ASCT. Disclosures: Kymes: Genzyme: Research Funding. Gregory:Genzyme: Research Funding. Lambert:Genzyme: Research Funding. DiPersio:Genzyme: Honoraria.

Peripheral Blood Stem Cell Mobilization by G-CSF Alone and Engraftment Kinetics Following Autologous Transplantation in Children and Adolescents with Solid Tumor.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5197-5197
Author(s):  
Hiroyoshi Watanabe ◽  
Tsutomu Watanabe ◽  
Hiroko Suzuya ◽  
Yoshifumi Wakata ◽  
Toshihiro Onishi ◽  
...  
Keyword(s):  
Stem Cell ◽  
Autologous Transplantation ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Platelet Recovery ◽  
Irradiation Group ◽  
Cd34 Cells ◽  
Pediatric Cancer Patients ◽  
Group 3 ◽  
Cell Mobilization

Abstract The purpose of this study was to examine the yield of PBSC, mobilized with G-CSF alone, and engraftment kinetics after autologous transplantation in pediatric cancer patients. In 55 patients (median age; 7 years, range 0–21) with various pediatric and adolescent solid tumors, PBSC were mobilized with G-CSF alone, and the yields of PBSC and engraftment following autologous PBSCT were evaluated retrospectively. Patients were categorized according to prior treatment; patients who had received less than 4 or 4 cycles of chemotherapy with/without local irradiation (Group 1: N= 21), patients who received more than 4 cycles of chemotherapy or 3 or more cycles of chemotherapy with extended irradiation (Group 2: N= 23), and patients who received high-dose chemotherapy with stem cell support (Group 3: N= 11). Ten microgram per kg of G-CSF was injected subcutaneously for mobilization when patients showed no influence of previous chemotherapy, and administration was continued for five days. The peaks of CD34+ cells and CFU-GM were observed on day 5 of G-CSF administration essentially in all patients. Aphereses were performed on days 5 and 6 of G-CSF treatment. Mobilization failure was observed in four patients in all groups. Compared with the results in patients mobilized by chemotherapy plus G-CSF (N=18), the progenitor cell yields were lower in those mobilized with G-CSF alone. However, there were no significant differences in WBC engraftment speed compared to the chemotherapy plus G-CSF mobilization group, although platelet recovery was delayed in patients with G-CSF alone, especially in patients in Group 3. The median time taken for ANC and platelet counts to reach 500 and 20K was 12 days (range 8–28) and 15 days (8–55), respectively, in all patients who were mobilized by G-CSF alone except for patients with progressive disease. In summary, mobilization with G-CSF alone can mobilize a sufficient number of CD34+ cells for successful autografting and sustained hematological reconstitution in pediatric patients with cancer, even in heavily pre-treated patients. Mobilization with G-CSF alone might offer some advantages, such as ease of determining a collection schedule without a daily determination of CD34+ cells in the blood, and the avoidance of neutropenic fever and additional transfusion.

Kinetics of Autologous Stem Cell Mobilization Failure: Comparison of AMD3100/G-CSF, G-CSF, GM-/G-CSF, and Chemotherapy/G-CSF on Remobilization Success.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3380-3380 ◽  
Author(s):  
John F. DiPersio ◽  
Angela Smith ◽  
Dianne Sempek ◽  
Albert Baker ◽  
Steven Jiang ◽  
...  
Keyword(s):  
Stem Cell ◽  
Surrogate Marker ◽  
Median Number ◽  
High Dose Chemotherapy ◽  
Disease State ◽  
High Dose ◽  
Factors Associated ◽  
Cd34 Cells ◽  
Cell Mobilization ◽  
Kinetics Of

Abstract Background: No standard approach for the mobilization of peripheral hematologic stem and progenitor cells (HSPCs) has been established. High levels of circulating CD34+ cells, a surrogate marker for mobilization efficiency, are associated with less apheresis days. A higher dose of CD34+ cell transfused after high-dose chemotherapy decreases time to hematologic recovery. Consequently, a better understanding of variables associated with mobilization kinetics may further optimize stem cell collection and reduce complications associated with autologous stem cell transplants. Methods: The Washington University (St. Louis, MO) transplantation database includes clinical parameters from 407 multiple myeloma (MM), 567 non-Hodgkin’s Lymphoma (NHL), and 164 Hodgkin’s disease (HD) pts who received an ASCT between 1995 and 2006. A retrospective analysis of this large pt population was conducted to determine factors associated with the mobilization kinetics of CD34+ cells. Results: Figure 1 summarizes the mobilization kinetics as defined by number of days to reach a target of 2 × 10^6 CD34+ cells/kg. Overall, the median number of aphereses to reach the target were 1, 2, and 2 in MM, NHL, and HD, respectively. Daily median CD34+ yields in MM pts were 3.8, 1.2, and 0.5 × 10^6 on day 1–3, respectively. In NHL pts, yields were 1.4, 0.8, and 0.4 × 10^6 on day 1–3. In HD pts, yields were 1.8, 0.8, and 0.3 × 10^6 on day 1–3, respectively. The addition of chemotherapy increased the % of pts requiring only a single apheresis to reach the mobilization target. Figure 2 summarizes the mobilization kinetics for each re-mobilization regimen. In general, a limited number of cells was collected with each aphereses; >70% of pts failed to mobilize 2 × 10^6 CD34+ cells/kg. In contrast, remobilization with AMD3100 allowed the collection of sufficient CD34+ cells in 67% of pts; median number of apheresis to reach the target was 3. Conclusions: Factors associated with mobilization kinetics of CD34+ cells include disease state and mobilization regimen. Re-mobilization is associated with high failure rates, re-mobilization regimens including AMD3100 are more successful. Figure 1: Mobilization kinetics by disease state Figure 1:. Mobilization kinetics by disease state Figure 2: Mobilization kinetics by re-mobilization regimen Figure 2:. Mobilization kinetics by re-mobilization regimen

DCEP (Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin) Followed by High-Dose G-CSF Is a Highly Efficient and Safe Regimen for Stem Cell Mobilization for Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3284-3284
Author(s):  
Jason P. Gonsky ◽  
Nikoletta Lendvai ◽  
Michele L. Donato ◽  
Scott D. Rowley ◽  
Andrew L. Pecora ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
High Dose Chemotherapy ◽  
High Yield ◽  
High Dose ◽  
Outpatient Basis ◽  
Stem Cell Rescue ◽  
Cd34 Cells ◽  
Cell Mobilization ◽  
Related Mortality

Abstract High dose chemotherapy with autologous stem cell rescue remains a standard therapy for multiple myeloma patients who can tolerate it. A mobilizing regimen for multiple myeloma should ideally allow for a high yield of CD34+ cells, provide anti-myeloma activity, be well tolerated, and have predictable kinetics regarding initiation of collection of stem cells. Higher numbers of infused autologous CD34+ cells allow for more rapid engraftment and lower incidence of transplant-related morbidity and mortality. The goal for patients with myeloma is to harvest enough CD34+ cells to provide at least two autologous transplants. Previous mobilization regimens utilized G-CSF alone or high-dose cyclophosphamide with G-CSF. However, high-dose cyclophosphamide (4–7g/m2) has only modest efficacy against myeloma and is associated with significant morbidity and up to 1–2% treatment-related mortality. DCEP (dexamethasone, cyclophosphamide, etoposide, cisplatin) is a well established regimen with good efficacy as salvage treatment for myeloma. Additionally, the use of DCEP with G-CSF for mobilization in myeloma has previously been reported to provide an average yield of approximately 6x106 CD34+ cells. We report our experience with DCEP and high-dose G-CSF in mobilizing 88 multiple myeloma patients since 2006. Our regimen consisted of 40 mg dexamethasone IV over 15 minutes x 4 days, cyclophosphamide 500 mg/m2, etoposide 40 mg/m2 (capped at 75 mg), and cisplatin 15 mg/m2 (capped at 25 mg), all continuous IV infusions over 24h x 4 days, with G-CSF starting 24–48h after completion of chemotherapy, administered SQ at 5 mcg/kg x 6 days followed by 10 mcg/kg daily until pheresis is completed. Over 80% of our patients were ready to initiate collection on day 14. Our goal for collection is 10–12x106 CD34+ cells to allow for two or three transplants using at least 4x106 CD34+ cells per transplant. Yields were excellent with a mean yield of 27x106 CD34+ cells, with a range of 7.3–130.5x106 CD34+ cells. 37/88 (42%) of patients required only one day of pheresis, with a mean yield of 34x106 CD34+ cells. 38/88 (43%) of patients required two days of pheresis. Only 15% of patients required more than two days of pheresis. Only 3 patients yielded fewer than 10x106 CD34+ cells (3%), and none yielded fewer than 5x106 CD34+ cells. In conclusion, this regimen is highly efficacious, offers excellent stem cell yields and predictable collection kinetics, can be administered on an outpatient basis, and is safe and well tolerated.

scholarly journals High CD34+ Cell Counts Decrease Hematologic Toxicity of Autologous Peripheral Blood Progenitor Cell Transplantation

Blood ◽  
1998 ◽  
Vol 91 (9) ◽  
pp. 3148-3155 ◽  
Author(s):  
Nicolas Ketterer ◽  
Gilles Salles ◽  
Michel Raba ◽  
Daniel Espinouse ◽  
Anne Sonet ◽  
...  
Keyword(s):  
Peripheral Blood ◽  
Progenitor Cell ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Lymphoproliferative Diseases ◽  
High Group ◽  
Platelet Recovery ◽  
Neutrophil Recovery ◽  
Intermediate Group ◽  
Cd34 Cells

Optimal numbers of CD34+ cells to be reinfused in patients undergoing peripheral blood progenitor cell (PBPC) transplantation after high-dose chemotherapy are still unknown. Hematologic reconstitution of 168 transplantations performed in patients with lymphoproliferative diseases was analyzed according to the number of CD34+ cells reinfused. The number of days from PBPC reinfusion until neutrophil recovery (>1.0 × 109/L) and unsustained platelet recovery (>50 × 109/L) were analyzed in three groups defined by the number of CD34+ cells reinfused: a low group with less than or equal to 2.5 × 106 CD34+ cells/kg, a high group with greater than 15 × 106 CD34+cells/kg, and an intermediate group to which the former two groups were compared. The 22 low-group patients had a significantly delayed neutrophil (P < .0001) and platelet recovery (P < .0001). The 41 high-group patients experienced significantly shorter engraftment compared with the intermediate group with a median of 11 (range, 8 to 16) versus 12 (range, 7 to 17) days for neutrophil recovery (P = .003), and a median of 11 (range, 7 to 24) versus 14 (range, 8 to 180+) days for platelet recovery (P< .0001). These patients required significantly less platelet transfusions (P = .002). In a multivariate analysis, the amount of CD34+ cells reinfused was the only variable showing significance for neutrophil and platelet recovery. High-group patients had a shorter hospital stay (P = .01) and tended to need fewer days of antibotic administration (P = .12). In conclusion, these results suggest that reinfusion of greater than 15 × 106 CD34+ cells/kg after high-dose chemotherapy for lymphoproliferative diseases further shortens hematopoietic reconstitution, reduces platelet requirements, and may improve patients' quality of life.

Sign in / Sign up

Export Citation Format

Share Document