{"protocolSection":{"identificationModule":{"nctId":"NCT01899326","orgStudyIdInfo":{"id":"2012-230"},"secondaryIdInfos":[{"id":"NCI-2013-01212","type":"REGISTRY","domain":"CTRP (Clinical Trial Reporting Program)"},{"id":"11-010"},{"id":"2012-230","type":"OTHER","domain":"Albert Einstein College of Medicine"},{"id":"P30CA013330","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P30CA013330"}],"organization":{"fullName":"Albert Einstein College of Medicine","class":"OTHER"},"briefTitle":"Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant","officialTitle":"Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma"},"statusModule":{"statusVerifiedDate":"2023-03","overallStatus":"TERMINATED","whyStopped":"The study was stopped during the interim analysis due to low accrual after the widespread use of plerixafor for multiple myeloma in the United States.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-03","type":"ACTUAL"},"completionDateStruct":{"date":"2015-03","type":"ACTUAL"},"studyFirstSubmitDate":"2013-07-11","studyFirstSubmitQcDate":"2013-07-11","studyFirstPostDateStruct":{"date":"2013-07-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2023-01-08","resultsFirstSubmitQcDate":"2023-03-02","resultsFirstPostDateStruct":{"date":"2023-03-28","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-03-02","lastUpdatePostDateStruct":{"date":"2023-03-28","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Amit Verma","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Albert Einstein College of Medicine"},"leadSponsor":{"name":"Albert Einstein College of Medicine","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This pilot clinical trial studied how well desipramine hydrochloride and filgrastim worked for stem cell mobilization in participants with multiple myeloma (MM) undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the participant's bone marrow to the blood so they can be collected and stored.","detailedDescription":"PRIMARY OBJECTIVES:\n\nI. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).\n\nII. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.\n\nOUTLINE:\n\nParticipants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.\n\nAfter completion of study treatment, participants were followed up to 1 week after completion of stem cell collection."},"conditionsModule":{"conditions":["DS (Durie/Salmon) Stage I Plasma Cell Myeloma","DS Stage II Plasma Cell Myeloma","DS Stage III Plasma Cell Myeloma","Refractory Plasma Cell Myeloma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":10,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Treatment (desipramine, filgrastim)","type":"EXPERIMENTAL","description":"Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.","interventionNames":["Drug: Desipramine Hydrochloride","Biological: Filgrastim","Other: Laboratory Biomarker Analysis"]}],"interventions":[{"type":"DRUG","name":"Desipramine Hydrochloride","description":"Given PO","armGroupLabels":["Treatment (desipramine, filgrastim)"],"otherNames":["Norpramin","Pertofrane"]},{"type":"BIOLOGICAL","name":"Filgrastim","description":"Given PO","armGroupLabels":["Treatment (desipramine, filgrastim)"],"otherNames":["G-CSF","Nivestim","r-metHuG-CSF"]},{"type":"OTHER","name":"Laboratory Biomarker Analysis","description":"Correlative studies","armGroupLabels":["Treatment (desipramine, filgrastim)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy","description":"Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of \\>=5 x 10\\^6 CD34+ cells/kg.","timeFrame":"Day 5"},{"measure":"Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy","description":"Success rate was assessed as the number of participants with Multiple Myeloma (MM) who Failed Prior Mobilization or who were Exposed to Alkylator Therapy or who were Predicted to be Difficult to Mobilize who completed the full course of filgrastim and desipramine and achieved the target collection of \\>=5 x 10\\^6 CD34+ cells/kg.","timeFrame":"Day 5"}],"secondaryOutcomes":[{"measure":"Median Number of Days of Apheresis","description":"Median number of days of apheresis required to collect \\>=5 x 10\\^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days"},{"measure":"Incidence of Adverse Events","description":"Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days"},{"measure":"Median Time to Neutrophil Engraftment","description":"Median time (number of days) to neutrophil engraftment was determined as first of three consecutive days with absolute neutrophil count (ANC) \\> 500/ul or first day with ANC \\> 1000/ul in the absence of growth factor support.","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days"},{"measure":"Median Time to Platelet Engraftment","description":"Median time (number of days) to platelet engraftment was determined as first of three consecutive days with platelets \\> 20,000/ul without transfusion.","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization\n* Ability to give informed consent\n* Glomerular filtration rate (GFR) \\> 30 ml/minute\n* Liver function tests \\< 2.5 x upper limit of normal (ULN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less\n* Based on prior therapy patients will be classified into two categories:\n\n  * Initial mobilizers with no exposure to alkylators\n  * Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization\n\nExclusion Criteria:\n\n* Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy\n* Concomitant therapy with any drugs shown to have major interactions with desipramine\n* Concurrent use of drugs that are contraindicated with desipramine\n* Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) \\> 460 msec\n* Active alcohol abuse\n* Bipolar disorder\n* Untreated active major depression\n* History of seizures in the past 3 years\n* Pregnancy and lactation; refusal to use adequate contraception\n* Uncontrolled thyroid disease\n* GCSF or pegfilgrastim use within 14 days prior to enrollment\n* Bortezomib, Revlimid or thalidomide use within 7 days of enrollment\n* Patients with sickle cell disease","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Murali Janakiram","affiliation":"Albert Einstein College of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Albert Einstein College of Medicine","city":"The Bronx","state":"New York","zip":"10461","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of the 10 participants enrolled, 1 participant dropped out after enrollment and prior to study drug initiation. Of the remaining 9 participants, 6 participants underwent stem cell transplantation and completed the full study protocol.","recruitmentDetails":"Ten participants with multiple myeloma between 18-70 years of age eligible for Autologous Stem Cell Transplant (ASCT) were enrolled in the study between September 2013 and July 2014.","groups":[{"id":"FG000","title":"Treatment (Desipramine, Filgrastim)","description":"Participants received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Disease Relapse (patient with previously undiagnosed relapsing disease)","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The respective baseline measures were provided for the 6 participants who completed the protocol.","groups":[{"id":"BG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"}]}],"measures":[{"title":"Age, Continuous","populationDescription":"Age range of the 6 patients who completed the study.","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.5","lowerLimit":"58","upperLimit":"70"}]}]}]},{"title":"Sex: Female, Male","populationDescription":"Gender of the 6 patients who completed the study.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Region of Enrollment","populationDescription":"Region of enrollment of the 6 patients who completed the study.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}]}]},{"title":"Prior Lenalidomide therapy","description":"Number of patients who had received Lenalidomide prior to the trial.","populationDescription":"Number of patients who had received Lenalidomide prior to the trial who completed the study.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"No","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Prior chemotherapies","description":"Number of prior chemotherapy treatments.","populationDescription":"Number of prior chemotherapy treatments for the study participants who completed the trial.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"One prior chemotherapy treatment","categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}]},{"title":">1 prior chemotherapy treatment","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy","description":"Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of \\>=5 x 10\\^6 CD34+ cells/kg.","populationDescription":"6 participants underwent stem cell transplantation and completed the full study protocol.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 5","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, apheresis was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}]},{"type":"PRIMARY","title":"Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy","description":"Success rate was assessed as the number of participants with Multiple Myeloma (MM) who Failed Prior Mobilization or who were Exposed to Alkylator Therapy or who were Predicted to be Difficult to Mobilize who completed the full course of filgrastim and desipramine and achieved the target collection of \\>=5 x 10\\^6 CD34+ cells/kg.","populationDescription":"No patients who failed prior mobilization or who were exposed to alkylator therapy or were predicted to be difficult to mobilize were enrolled and as such no data was collected/analyzed for this Outcome Measure.","reportingStatus":"POSTED","timeFrame":"Day 5","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Median Number of Days of Apheresis","description":"Median number of days of apheresis required to collect \\>=5 x 10\\^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.","populationDescription":"6 participants underwent stem cell transplantation and completed the full study protocol.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Days","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","lowerLimit":"1","upperLimit":"2"}]}]}]},{"type":"SECONDARY","title":"Incidence of Adverse Events","description":"Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).","populationDescription":"6 participants underwent stem cell transplantation and completed the full study protocol.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Adverse Events","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, apheresis was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}]},{"type":"SECONDARY","title":"Median Time to Neutrophil Engraftment","description":"Median time (number of days) to neutrophil engraftment was determined as first of three consecutive days with absolute neutrophil count (ANC) \\> 500/ul or first day with ANC \\> 1000/ul in the absence of growth factor support.","populationDescription":"6 participants underwent stem cell transplantation and completed the full study protocol.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"number of days","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12","lowerLimit":"11.8","upperLimit":"12"}]}]}]},{"type":"SECONDARY","title":"Median Time to Platelet Engraftment","description":"Median time (number of days) to platelet engraftment was determined as first of three consecutive days with platelets \\> 20,000/ul without transfusion.","populationDescription":"6 participants underwent stem cell transplantation and completed the full study protocol.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"number of days","timeFrame":"Up to 1 week following completion of study treatment, up to 15 days","groups":[{"id":"OG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.5","lowerLimit":"12","upperLimit":"14.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Subjects were monitored for incidence of Adverse Events up to 1 week following completion of treatment, for a total of up to 15 days","eventGroups":[{"id":"EG000","title":"Treatment (Desipramine, Filgrastim)","description":"Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \\<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\\^6 cells/kg was reached. If the collected CD34+ cell dose was \\<0.5x10\\^6 on two consecutive days, aperheris was stopped and the patient was taken off study.\n\nDespiramine hydrochloride: PO Filgrastim: PO","deathsNumAffected":0,"deathsNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"otherNumAffected":6,"otherNumAtRisk":6}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":6}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Dry Mouth","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":6}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Target enrollment (n=20) was not reached. The study was stopped during the interim analysis due to low accrual after the widespread use of plerixafor for multiple myeloma in the United States."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Amit Verma","organization":"Albert Einstein College of Medicine","email":"amit.verma@einsteinmed.edu","phone":"718-430-4091"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009101","term":"Multiple Myeloma"}],"ancestors":[{"id":"D054219","term":"Neoplasms, Plasma Cell"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D020141","term":"Hemostatic Disorders"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D010265","term":"Paraproteinemias"},{"id":"D001796","term":"Blood Protein Disorders"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D006474","term":"Hemorrhagic Disorders"},{"id":"D008232","term":"Lymphoproliferative Disorders"},{"id":"D007160","term":"Immunoproliferative Disorders"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D003891","term":"Desipramine"},{"id":"D000069585","term":"Filgrastim"},{"id":"D016179","term":"Granulocyte Colony-Stimulating Factor"}],"ancestors":[{"id":"D003984","term":"Dibenzazepines"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D003115","term":"Colony-Stimulating Factors"},{"id":"D006023","term":"Glycoproteins"},{"id":"D006001","term":"Glycoconjugates"},{"id":"D002241","term":"Carbohydrates"},{"id":"D016298","term":"Hematopoietic Cell Growth Factors"},{"id":"D016207","term":"Cytokines"},{"id":"D036341","term":"Intercellular Signaling Peptides and Proteins"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":true}