[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100216691":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":27,"locations":54,"responsibleParty":67,"collaborators":27,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":27,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":27,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":27,"overallStatus":89,"whyStopped":27,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"XM02 Filgrastim (Granix) and Plerixafor","EXPERIMENTAL","* XM02 Filgrastim (Granix) 10 mg\u002Fkg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)\n* Plerixafor 0.24 mg\u002Fkg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)\n* Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)\n* Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+\u002F- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \\> 2.0 x 10\\^6 CD34+ cells\u002Fkg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.",[13,14,15,16],"Drug: XM02 Filgrastim","Procedure: Apheresis","Drug: Plerixafor","Procedure: Stem Cell Transplant",{"label":18,"type":19,"description":20,"interventionNames":21},"Filgrastim (Neupogen) and Plerixafor","ACTIVE_COMPARATOR","* Filgrastim (Neupogen) 10 mg\u002Fkg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)\n* Plerixafor 0.24 mg\u002Fkg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)\n* Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)\n* Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+\u002F- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \\> 2.0 x 10\\^6 CD34+ cells\u002Fkg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.",[22,14,15,16],"Drug: Filgrastim",[24,31,36,40,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","XM02 Filgrastim",null,[9],[30],"Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix",{"type":25,"name":32,"description":27,"armGroupLabels":33,"otherNames":34},"Filgrastim",[18],[35],"Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF",{"type":37,"name":38,"description":27,"armGroupLabels":39,"otherNames":27},"PROCEDURE","Apheresis",[18,9],{"type":25,"name":41,"description":27,"armGroupLabels":42,"otherNames":43},"Plerixafor",[18,9],[44],"Mozobil, AMD3100",{"type":37,"name":46,"description":27,"armGroupLabels":47,"otherNames":48},"Stem Cell Transplant",[18,9],[49],"ASCT",[51],{"name":52,"affiliation":5,"role":53},"Camille Abboud, M.D.","PRINCIPAL_INVESTIGATOR",[55],{"facility":5,"status":27,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":27},"St Louis","Missouri","63110","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-90.19789,38.62727,{"lat":65,"lon":64},{"type":68,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100216691","phase-2-non-inferiority-study-of-xm02-filgrastim-granix-and-filgrastim-neupogen-in-combination-with-plerixafor-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma-or-non-hodgkin-lymphoma-100216691",true,"NCT02098109","Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma","A Randomized, Open Label, Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) When Administered in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* At least 18 years of age\n* Diagnosis of multiple myeloma or non-Hodgkin lymphoma\n* Eligible for autologous transplantation\n* Adequate bone marrow function as defined as:\n\n  * White Blood Cell Count ≥ 3.0x109\u002FL\n  * Absolute Neutrophil Count ≥ 1.5x109\u002FL\n  * Platelet Count ≥ 100x109\u002FL\n* Able to understand and willing to sign an IRB-approved informed consent document\n* Surgically or biologically sterile or willing to practice acceptable birth control, as follows:\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure\u002Fregimen during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal\u002Fimplanted or injected contraceptives, and abstinence\n  * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal\u002Fimplanted or injected contraceptives, and abstinence\n\nExclusion Criteria:\n\n* Previous autologous stem cell collection\n* Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products\n* Pregnant or breastfeeding",false,"ALL","18 Years",{"count":80,"type":81},100,"ACTUAL","INTERVENTIONAL",[84],"PHASE2","This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.",[87,88],"Multiple Myeloma","Lymphoma, Non-Hodgkin","COMPLETED","2017-07-17",{"date":92,"type":81},"2017-07-18",{"date":94,"type":81},"2014-08-20",{"date":96,"type":81},"2016-09-18",{"name":5,"class":6},1]