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M2) as Conditioning for Autologous Stem Cell Transplantation for Myeloma in Elderly Patients
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
between pts who received PCP prophylaxis for up to 3 vs 6 months post AHSCT. 86 pts were included with median age 63 years (range: 3579), 33 female (38.4%) and 53 male (61.6%). 4 had amyloidosis and 82 had multiple myeloma (MM). Of MM pts, 54 (65.9%) were IgG subtype, 16 IgA (19.5%) and 12 in other subtypes (14.6%). By Durie Salmon staging, 48 pts (58%) had stage III, 23 (26.7%) stage II, 8 (9.3%) stage I disease and for 3 it was unknown. All pts received aerosolized pentamidine 3 days before AHSCT. Many conditioning regimens were used but mainly Melphalan 200 mg/m2 (43%) and Melphalan 140 mg/ m2 (36%) were given on day 1. Median number of cells infused was 3.36 million/kg (range: .02-7.64 million/kg). PCP prophylaxis was started on D+30 in all but 2 pts. TMPSMZ was used as first agent in 60 pts (70.6%). It could not be used in rest due to either history of sulfa allergy (11.7%) or history of TMP-SMZ side effects or presence of acute kidney injury. Of 60 in whom it was used first line it was switched to other agents in 4 pts (4.7%) due to side effects. 22 pts (26.5%) received some form of PCP prophylaxis up to 3 months and 60 (72.3%) up to 6 months. No PCP diagnosis was made in any pts up to 6 months post AHSCT, regardless of duration and type of medication used for PCP prophylaxis. TMP-SMZ was not used in 30% pts due to various reasons and in another 4.7% had to be switched to a different agent due to cytopenias. Hemolysis, transaminitis, hyerbilirubinemia, rash were other adverse events. Due to these side effects, medications other than TMP-SMZ can be considered in this group of pts for PCP prophylaxis. Aerosolized pentamidine monthly is an alternative. This retrospective review raises possibility that for AHSCT recipients for PCD, shorter than 6 months prophylaxis duration was not sub-optimal. It would be worthwhile to validate this information in other centers with larger data set and also compare it with data from centers that do not routinely administer PCP prophylaxis post AHSCT.
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Bendamustine is an effective drug and when given with other combination chemotherapy as a conditioning regime, is well tolerated at a dose of 300 mg/M^2.
145 Evaluation of the Efficacy and Safety of Darbepoetin Alfa in Reducing the Transfusion Requirements in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation for Hematological Malignancies Joydeep Chakrabartty 1, Neelesh Jain 2, Kasturi Sengupta 3, Debarghya Mukherjee 4, Pooja Sarada 2, Anil Arlbandi 5, Nitin Sood 6, Amrita Chakravarti 2, Amitabh Ray 7. 1 Haematology and Stem Cell Transplant, AMRI Hospitals, Kolkata, India; 2 Apollo Glenagles Hospital, Kolkata, India; 3 Tata Medical Centre, Kolkata, India; 4 Haematology, AMRI Hospitals, Kolkata, India; 5 Haematology, American Oncology Institute, Hyderabad, India; 6 Medanta Medi City, Delhi, India; 7 AMRI Hospitals, Kolkata, India We conducted a randomized study analyzing the impact of Darbepoetin Alfa (DA) in reducing transfusion requirements during autologous stem cell transplant. Group A had seventeen patients where darbapoietin alpha was not used. The other group so far has 10 patients. In the later group Darbapoietin was given on Day -14, Day -7 and on day +7, Iv iron was given on day-14, and day -7. We found that the incidence of transfusion requirements have gone down drastically in the DA arm of the study with a mean requirement of .9 units per patient where as previously it was 2.3 units per patient. Though it has multiple variables the reduction in transfusion by using 3 doses of DA is encouraging specially in a country like India where an universal transfusion policy has yet to be developed and the safety and availability of blood products vary between instituitions.
144
146
Bendamustine-Based Conditioning Regime (BACE-Bendamustine, Cytarabine, Cyclophosphamide and Etoposide) for Patients with Lymphoma Undergoing Autologous Stem Cell Transplant Joydeep Chakrabartty 1, Neelesh Jain 2, Pooja Sarada 2, Kasturi Sengupta 3, Nitin Sood 4, Anil Arabandi 5, Amrita Chakravarti 2, Amitabh Ray 6. 1 Haematology and Stem Cell Transplant, AMRI Hospitals, Kolkata, India; 2 Apollo Glenagles Hospital, Kolkata, India; 3 Tata Medical Centre, Kolkata, India; 4 Medanta Medi City, Delhi, India; 5 Indo American Hospital, Hyderabad, India; 6 AMRI Hospitals, Kolkata, India
Safety of High-Dose Melphalan (200 Mg/M2) as Conditioning for Autologous Stem Cell Transplantation for Myeloma in Elderly Patients Amrita Desai 1, Amer Beitinjaneh 2, Jeremy Ramdial 2, Robert Ali 2, Lazaros Lekakis 3, Denise Pereira 3, Erik Kimble 4, Vaia Florou 4, Gabriela Bravo 4, Mark Goodman 3, John J. Byrnes 3, Antonio M. Jimenez 3, Seyyedeh Saneeymehri 1, Krishna V. Komanduri 3. 1 Hematology Oncology, University of Miami, Miami, FL; 2 Hematology Oncology, University of Virginia School of Medicine, Charlottesville, VA; 3 Adult Stem Cell Transplant Program, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL; 4 Internal Medicine, University of Miami, Miami, FL
We have already shown that Bendamustine when replaced for Lomustine is an effective and safe regime for autologous stem cell transplant for relapsed and refractory high grade lymphomas including Diffuse large B cell lymphoma, Hodgkins Lymphoma, Grey zone Lymphomas, mantle cell lymphomas etc. From June 2012 to May 2014, 17 patients were transplanted with the BACE regime with a total dose of Bendamustine of 200 mg/m^2. From July 2104 till July 2016 we have done another 12 autologous transplant with a dose of Bendamustine-150 mg/M^2 for 2 days along with Cytarabine- ARAC, Cyclophosphamide and Etoposide. All the 12 patients are alive and no TRM has been reported. One patient with a Grey Zone Lymphoma has relapsed 4 months after his transplant. But the rest 11 and the previous 17 continue to be in remission. There was no Grade 3-4 non haematological toxicity and the maximum mucositis that we encountered was Grade 2. So as mentioned previously
Background: Autologous stem cell transplantation (ASCT) remains the standard of care in the treatment of multiple myeloma (MM) even in the era of novel agents. Many studies have shown that ASCT is safe in elderly patients; however, Melphalan dose in the elderly is commonly reduced to doses less than 200 mg/m2 given concerns of toxicity and tolerability. Methods: We conducted a single-center, retrospective analysis of consecutive elderly patients (>65 years old) with MM transplanted between 2011 and 2016, all of whom received high-dose melphalan (HDM) at a dose of 200 mg/m2 as a conditioning regimen for ASCT. We compared outcomes in patients between 65-69 years with those in a contemporaneous subset of matched younger control patients younger than 65 years. We collected information on demographics, subtype, International Staging System (ISS) stage, laboratory
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Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
Table 1 Toxicities (Grade II-IV)
Age 65-69 years (n = 49)
Age < 65 years (n = 47)
P value*
Cardiac toxicities Renal Insufficiency Infections† Neutropenic Fever Rash/Allergic Reactions GI toxicities (Grade III-IV)
4 (8.1%) 2 (4%) 12 (24.4%) 12 (24.4%) 4 (8.1%) 6 (12.2%)
2 (4.2%) 1 (2.1%) 8 (17%) 13 (27.6%) 5 (10.6%) 8 (17%)
.42 .58 .36 .72 .7 .51
*P-value <.05. †by radiology or microbiology.
data, treatment and response, toxicities, and hospital stay. The Kaplan-Meier method was used to estimate progressionfree survival (PFS), and overall survival (OS). Results: We analyzed 68 cases treated with HDM as a conditioning regimen for ASCT. The median age at ASCT was 67 years. The median number of induction regimens prior to transplant was 1 (range 1-6). Males accounted for 52.9% and Hispanics 51.4%. After a median follow-up of 1.3 years, the estimated progression-free survival and overall survival at 2 years were 60.5% and 88%, respectively. Interestingly, the day100 non-relapse mortality was 0% amongst the 68 cases. We compared cases aged 65-69 (n = 49) with matched controls aged <65 (n = 47) and found no age-dependent differences in grade II-IV toxicities including cardiac, renal, GI toxicities, infectious complications and rash (Table 1). There was no difference in the median time to neutrophil (10 days) and platelet engraftment (18 days) between the two groups nor median length of hospital stay (16 and 14 days, respectively). A subset of patients aged >70 years (n = 19) had no higher incidence of toxicities or longer hospital stays compared to younger patients. Conclusions: In our study we found that elderly patients with MM undergoing ASCT with high dose Melphalan at a dose of 200 mg/m2have similar toxicity profiles compared to younger patients. Thus, high-dose mephalan without dose adjustment is a safe treatment for elderly patients with a good baseline performance status.
147 Autologous Stem Cell Mobilization with Tbo-Filgrastim is Equvalent to Filgrastim: Results From a Randomized Phase II Trial Mark A. Fiala, Ravi Vij, Amanda Cashen, Keith Stockerl-Goldstein, John F. DiPersio, Camille Abboud. Bone Marrow Transplantation & Leukemia Section, Division of Oncology, Washington University School of Medicine, St. Louis, MO Background: There is ongoing debate regarding the use of granulocyte colony stimulating factor (G-CSF) biosimilars for peripheral blood hematopoietic stem cell (PBSC) mobilization. Their use in the autologous setting is supported by several retrospective studies but there have been no prospective randomized trials reported to date. Therefore, we conducted a randomized phase II trial to compare the safety and efficacy of tbo-filgrastim and filgrastim for PBSC mobilization. Methods: Participants were at least 18-years-old, had a diagnosis of multiple myeloma (MM) or non-Hodgkin Lymphoma (NHL), and meet institutional guidelines for autologous stem cell transplantation (ASCT). Those with impaired hematologic function or had undergone a previous mobilization were excluded. Tbo-filgrastim/filgrastim (10 mcg/ kg) was administered daily for 5 days. On the evening of Day
4, plerixafor (.24 mg/kg) was administered; apheresis (20L) was performed 12-15 hours later. If a participant failed to achieve the target collection goal (5.0 × 106 cells/kg), they continued to receive daily tbo-filgrastim/filgrastim, plerixafor, and apheresis for up to 3 additional days. Participants subsequently underwent ASCT per institutional guidelines. Statistics: The study was powered to detect non-inferiority in Day 5 PBSC (CD34+) yield with a margin of 12% with 80% power at 1-sided .2 alpha. Results: 97 evaluable participants were enrolled; 46 were randomized to tbo-filgrastim and 51 to filgrastim. The median age was 60 years (range 40-77); 62% were male; 89% had MM, 11% NHL. Both treatment arms were well tolerated and toxicity was generally mild. The most common non-hematologic toxicities were bone pain (42%), increased alkaline phosphatase (23%), and nausea/vomiting (21%); rates were similar between the two treatment arms. Day 5 PBSC yield was similar between both arms; the mean yield was 11.6 × 106/kg (80% CI 10.3-12.9) for tbo-filgrastim compared to 10.0x106/kg (80% CI 8.8-11.3) for filgrastim (P = .873). In multivariate analysis, there was a trend for higher yields in the tbo-filgrastim arm, but it was not statistically significant. Circulating PBSC counts were also similar between both arms. The mean PBSC count on day 4 (pre-plerixafor) was 26/uL in the tbo-filgrastim arm compared to 24/uL the filgrastim arm (P = .604); on Day 5 (pre-apheresis) it was for 110/uL compared to 92/uL (P = .158). 94 participants subsequently underwent ASCT. Post-ASCT engraftment was similar for both arms. The median intervals of neutrophil and platelet engraftment for tbo-filgrastim were 11 and 18 days compared to 11.5 and 17.5 days for filgrastim (P = .737; .812). Conclusion: Tbo-filgrastim and filgrastim are similar in safety and efficacy for PBSC mobilization in MM or NHL patients undergoing ASCT.
148 Prospective Observational Study Evaluating Risk Factors for Plasma Cell (PC) Contamination of Cellular Products in Multiple Myeloma (MM) Patients (Pts) Mobilized with G-CSF (G)/Plerixafor (P) Laahn H. Foster 1, Adam J. Schettler 1, Bethany J. Horton 2, Tamila L. Kindwall-Keller 3. 1 Hematology Oncology, University of Virginia, Charlottesville, VA; 2 Applied Statistics, University of Virginia, Charlottesville, VA; 3 Hematology Oncology, University of Virginia School of Medicine, Charlottesville, VA Background: Retrospective analysis presented by our group in 2015 suggested higher relapse rates in MM pts mobilized with G/P and transplanted with CD34-CDI > 4 × 10^6 cells/kg, raising the question of PC contamination with higher CD34-CDI during autologous stem cell transplant (ASCT). We report preliminary results of an ongoing prospective observational study evaluating the relationship of CD34-CDI, cytogenetic risk factors, and treatment response level to PC content in the cellular product of MM pts mobilized with G/P. Methods: MM pts eligible for ASCT were enrolled from 5/2014-9/2016 and consented on the first day of apheresis. Pt demographics, disease characteristics, cytogenetics, CD34CDI, and treatment response achieved before ASCT were obtained. Mobilization was performed with G (10 mcg/kg/ day) plus P (.24 mg/kg evening of day four), with a goal of collecting 6-10 × 10^6 CD34 + cells/kg, sufficient to support two ASCTs. If > 6 × 10^6 CD34 + cells/kg were collected, the cellular product was divided equally for two ASCT. Flow
between pts who received PCP prophylaxis for up to 3 vs 6 months post AHSCT. 86 pts were included with median age 63 years (range: 3579), 33 female (38.4%) and 53 male (61.6%). 4 had amyloidosis and 82 had multiple myeloma (MM). Of MM pts, 54 (65.9%) were IgG subtype, 16 IgA (19.5%) and 12 in other subtypes (14.6%). By Durie Salmon staging, 48 pts (58%) had stage III, 23 (26.7%) stage II, 8 (9.3%) stage I disease and for 3 it was unknown. All pts received aerosolized pentamidine 3 days before AHSCT. Many conditioning regimens were used but mainly Melphalan 200 mg/m2 (43%) and Melphalan 140 mg/ m2 (36%) were given on day 1. Median number of cells infused was 3.36 million/kg (range: .02-7.64 million/kg). PCP prophylaxis was started on D+30 in all but 2 pts. TMPSMZ was used as first agent in 60 pts (70.6%). It could not be used in rest due to either history of sulfa allergy (11.7%) or history of TMP-SMZ side effects or presence of acute kidney injury. Of 60 in whom it was used first line it was switched to other agents in 4 pts (4.7%) due to side effects. 22 pts (26.5%) received some form of PCP prophylaxis up to 3 months and 60 (72.3%) up to 6 months. No PCP diagnosis was made in any pts up to 6 months post AHSCT, regardless of duration and type of medication used for PCP prophylaxis. TMP-SMZ was not used in 30% pts due to various reasons and in another 4.7% had to be switched to a different agent due to cytopenias. Hemolysis, transaminitis, hyerbilirubinemia, rash were other adverse events. Due to these side effects, medications other than TMP-SMZ can be considered in this group of pts for PCP prophylaxis. Aerosolized pentamidine monthly is an alternative. This retrospective review raises possibility that for AHSCT recipients for PCD, shorter than 6 months prophylaxis duration was not sub-optimal. It would be worthwhile to validate this information in other centers with larger data set and also compare it with data from centers that do not routinely administer PCP prophylaxis post AHSCT.
S127
Bendamustine is an effective drug and when given with other combination chemotherapy as a conditioning regime, is well tolerated at a dose of 300 mg/M^2.
145 Evaluation of the Efficacy and Safety of Darbepoetin Alfa in Reducing the Transfusion Requirements in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation for Hematological Malignancies Joydeep Chakrabartty 1, Neelesh Jain 2, Kasturi Sengupta 3, Debarghya Mukherjee 4, Pooja Sarada 2, Anil Arlbandi 5, Nitin Sood 6, Amrita Chakravarti 2, Amitabh Ray 7. 1 Haematology and Stem Cell Transplant, AMRI Hospitals, Kolkata, India; 2 Apollo Glenagles Hospital, Kolkata, India; 3 Tata Medical Centre, Kolkata, India; 4 Haematology, AMRI Hospitals, Kolkata, India; 5 Haematology, American Oncology Institute, Hyderabad, India; 6 Medanta Medi City, Delhi, India; 7 AMRI Hospitals, Kolkata, India We conducted a randomized study analyzing the impact of Darbepoetin Alfa (DA) in reducing transfusion requirements during autologous stem cell transplant. Group A had seventeen patients where darbapoietin alpha was not used. The other group so far has 10 patients. In the later group Darbapoietin was given on Day -14, Day -7 and on day +7, Iv iron was given on day-14, and day -7. We found that the incidence of transfusion requirements have gone down drastically in the DA arm of the study with a mean requirement of .9 units per patient where as previously it was 2.3 units per patient. Though it has multiple variables the reduction in transfusion by using 3 doses of DA is encouraging specially in a country like India where an universal transfusion policy has yet to be developed and the safety and availability of blood products vary between instituitions.
144
146
Bendamustine-Based Conditioning Regime (BACE-Bendamustine, Cytarabine, Cyclophosphamide and Etoposide) for Patients with Lymphoma Undergoing Autologous Stem Cell Transplant Joydeep Chakrabartty 1, Neelesh Jain 2, Pooja Sarada 2, Kasturi Sengupta 3, Nitin Sood 4, Anil Arabandi 5, Amrita Chakravarti 2, Amitabh Ray 6. 1 Haematology and Stem Cell Transplant, AMRI Hospitals, Kolkata, India; 2 Apollo Glenagles Hospital, Kolkata, India; 3 Tata Medical Centre, Kolkata, India; 4 Medanta Medi City, Delhi, India; 5 Indo American Hospital, Hyderabad, India; 6 AMRI Hospitals, Kolkata, India
Safety of High-Dose Melphalan (200 Mg/M2) as Conditioning for Autologous Stem Cell Transplantation for Myeloma in Elderly Patients Amrita Desai 1, Amer Beitinjaneh 2, Jeremy Ramdial 2, Robert Ali 2, Lazaros Lekakis 3, Denise Pereira 3, Erik Kimble 4, Vaia Florou 4, Gabriela Bravo 4, Mark Goodman 3, John J. Byrnes 3, Antonio M. Jimenez 3, Seyyedeh Saneeymehri 1, Krishna V. Komanduri 3. 1 Hematology Oncology, University of Miami, Miami, FL; 2 Hematology Oncology, University of Virginia School of Medicine, Charlottesville, VA; 3 Adult Stem Cell Transplant Program, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL; 4 Internal Medicine, University of Miami, Miami, FL
We have already shown that Bendamustine when replaced for Lomustine is an effective and safe regime for autologous stem cell transplant for relapsed and refractory high grade lymphomas including Diffuse large B cell lymphoma, Hodgkins Lymphoma, Grey zone Lymphomas, mantle cell lymphomas etc. From June 2012 to May 2014, 17 patients were transplanted with the BACE regime with a total dose of Bendamustine of 200 mg/m^2. From July 2104 till July 2016 we have done another 12 autologous transplant with a dose of Bendamustine-150 mg/M^2 for 2 days along with Cytarabine- ARAC, Cyclophosphamide and Etoposide. All the 12 patients are alive and no TRM has been reported. One patient with a Grey Zone Lymphoma has relapsed 4 months after his transplant. But the rest 11 and the previous 17 continue to be in remission. There was no Grade 3-4 non haematological toxicity and the maximum mucositis that we encountered was Grade 2. So as mentioned previously
Background: Autologous stem cell transplantation (ASCT) remains the standard of care in the treatment of multiple myeloma (MM) even in the era of novel agents. Many studies have shown that ASCT is safe in elderly patients; however, Melphalan dose in the elderly is commonly reduced to doses less than 200 mg/m2 given concerns of toxicity and tolerability. Methods: We conducted a single-center, retrospective analysis of consecutive elderly patients (>65 years old) with MM transplanted between 2011 and 2016, all of whom received high-dose melphalan (HDM) at a dose of 200 mg/m2 as a conditioning regimen for ASCT. We compared outcomes in patients between 65-69 years with those in a contemporaneous subset of matched younger control patients younger than 65 years. We collected information on demographics, subtype, International Staging System (ISS) stage, laboratory
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Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
Table 1 Toxicities (Grade II-IV)
Age 65-69 years (n = 49)
Age < 65 years (n = 47)
P value*
Cardiac toxicities Renal Insufficiency Infections† Neutropenic Fever Rash/Allergic Reactions GI toxicities (Grade III-IV)
4 (8.1%) 2 (4%) 12 (24.4%) 12 (24.4%) 4 (8.1%) 6 (12.2%)
2 (4.2%) 1 (2.1%) 8 (17%) 13 (27.6%) 5 (10.6%) 8 (17%)
.42 .58 .36 .72 .7 .51
*P-value <.05. †by radiology or microbiology.
data, treatment and response, toxicities, and hospital stay. The Kaplan-Meier method was used to estimate progressionfree survival (PFS), and overall survival (OS). Results: We analyzed 68 cases treated with HDM as a conditioning regimen for ASCT. The median age at ASCT was 67 years. The median number of induction regimens prior to transplant was 1 (range 1-6). Males accounted for 52.9% and Hispanics 51.4%. After a median follow-up of 1.3 years, the estimated progression-free survival and overall survival at 2 years were 60.5% and 88%, respectively. Interestingly, the day100 non-relapse mortality was 0% amongst the 68 cases. We compared cases aged 65-69 (n = 49) with matched controls aged <65 (n = 47) and found no age-dependent differences in grade II-IV toxicities including cardiac, renal, GI toxicities, infectious complications and rash (Table 1). There was no difference in the median time to neutrophil (10 days) and platelet engraftment (18 days) between the two groups nor median length of hospital stay (16 and 14 days, respectively). A subset of patients aged >70 years (n = 19) had no higher incidence of toxicities or longer hospital stays compared to younger patients. Conclusions: In our study we found that elderly patients with MM undergoing ASCT with high dose Melphalan at a dose of 200 mg/m2have similar toxicity profiles compared to younger patients. Thus, high-dose mephalan without dose adjustment is a safe treatment for elderly patients with a good baseline performance status.
147 Autologous Stem Cell Mobilization with Tbo-Filgrastim is Equvalent to Filgrastim: Results From a Randomized Phase II Trial Mark A. Fiala, Ravi Vij, Amanda Cashen, Keith Stockerl-Goldstein, John F. DiPersio, Camille Abboud. Bone Marrow Transplantation & Leukemia Section, Division of Oncology, Washington University School of Medicine, St. Louis, MO Background: There is ongoing debate regarding the use of granulocyte colony stimulating factor (G-CSF) biosimilars for peripheral blood hematopoietic stem cell (PBSC) mobilization. Their use in the autologous setting is supported by several retrospective studies but there have been no prospective randomized trials reported to date. Therefore, we conducted a randomized phase II trial to compare the safety and efficacy of tbo-filgrastim and filgrastim for PBSC mobilization. Methods: Participants were at least 18-years-old, had a diagnosis of multiple myeloma (MM) or non-Hodgkin Lymphoma (NHL), and meet institutional guidelines for autologous stem cell transplantation (ASCT). Those with impaired hematologic function or had undergone a previous mobilization were excluded. Tbo-filgrastim/filgrastim (10 mcg/ kg) was administered daily for 5 days. On the evening of Day
4, plerixafor (.24 mg/kg) was administered; apheresis (20L) was performed 12-15 hours later. If a participant failed to achieve the target collection goal (5.0 × 106 cells/kg), they continued to receive daily tbo-filgrastim/filgrastim, plerixafor, and apheresis for up to 3 additional days. Participants subsequently underwent ASCT per institutional guidelines. Statistics: The study was powered to detect non-inferiority in Day 5 PBSC (CD34+) yield with a margin of 12% with 80% power at 1-sided .2 alpha. Results: 97 evaluable participants were enrolled; 46 were randomized to tbo-filgrastim and 51 to filgrastim. The median age was 60 years (range 40-77); 62% were male; 89% had MM, 11% NHL. Both treatment arms were well tolerated and toxicity was generally mild. The most common non-hematologic toxicities were bone pain (42%), increased alkaline phosphatase (23%), and nausea/vomiting (21%); rates were similar between the two treatment arms. Day 5 PBSC yield was similar between both arms; the mean yield was 11.6 × 106/kg (80% CI 10.3-12.9) for tbo-filgrastim compared to 10.0x106/kg (80% CI 8.8-11.3) for filgrastim (P = .873). In multivariate analysis, there was a trend for higher yields in the tbo-filgrastim arm, but it was not statistically significant. Circulating PBSC counts were also similar between both arms. The mean PBSC count on day 4 (pre-plerixafor) was 26/uL in the tbo-filgrastim arm compared to 24/uL the filgrastim arm (P = .604); on Day 5 (pre-apheresis) it was for 110/uL compared to 92/uL (P = .158). 94 participants subsequently underwent ASCT. Post-ASCT engraftment was similar for both arms. The median intervals of neutrophil and platelet engraftment for tbo-filgrastim were 11 and 18 days compared to 11.5 and 17.5 days for filgrastim (P = .737; .812). Conclusion: Tbo-filgrastim and filgrastim are similar in safety and efficacy for PBSC mobilization in MM or NHL patients undergoing ASCT.
148 Prospective Observational Study Evaluating Risk Factors for Plasma Cell (PC) Contamination of Cellular Products in Multiple Myeloma (MM) Patients (Pts) Mobilized with G-CSF (G)/Plerixafor (P) Laahn H. Foster 1, Adam J. Schettler 1, Bethany J. Horton 2, Tamila L. Kindwall-Keller 3. 1 Hematology Oncology, University of Virginia, Charlottesville, VA; 2 Applied Statistics, University of Virginia, Charlottesville, VA; 3 Hematology Oncology, University of Virginia School of Medicine, Charlottesville, VA Background: Retrospective analysis presented by our group in 2015 suggested higher relapse rates in MM pts mobilized with G/P and transplanted with CD34-CDI > 4 × 10^6 cells/kg, raising the question of PC contamination with higher CD34-CDI during autologous stem cell transplant (ASCT). We report preliminary results of an ongoing prospective observational study evaluating the relationship of CD34-CDI, cytogenetic risk factors, and treatment response level to PC content in the cellular product of MM pts mobilized with G/P. Methods: MM pts eligible for ASCT were enrolled from 5/2014-9/2016 and consented on the first day of apheresis. Pt demographics, disease characteristics, cytogenetics, CD34CDI, and treatment response achieved before ASCT were obtained. Mobilization was performed with G (10 mcg/kg/ day) plus P (.24 mg/kg evening of day four), with a goal of collecting 6-10 × 10^6 CD34 + cells/kg, sufficient to support two ASCTs. If > 6 × 10^6 CD34 + cells/kg were collected, the cellular product was divided equally for two ASCT. Flow