Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT00395967
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'C088327', 'term': 'plerixafor'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-745-4447', 'title': 'Genzyme Medical Information', 'organization': 'Genzyme Corporation'}, 'certainAgreement': {'otherDetails': 'In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limited enrollment due to early termination of the study.'}}, 'adverseEventsModule': {'timeFrame': 'All treatment-emergent AEs are summarized. An event whose onset was on or after the first administration of study treatment (either G-CSF or plerixafor) was considered treatment-emergent.', 'description': 'In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events regardless of reported relationship to study treatment or grade.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients (3 NHL, 1 MM, and 1 HD).', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Skin tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'notes': 'Acute MI: Onset 15 days after last plerixafor dose, occurred during stem cell infusion, and assessed unrelated.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'classes': [{'title': 'Participants with ≥2*10^6 CD34+ cells/kg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Participants with <2*10^6 CD34+ cells/kg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately days 6-9', 'description': 'The number of patients with a circulating CD34+ count \\>= 5 and \\< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\\*10\\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received plerixafor.'}, {'type': 'SECONDARY', 'title': 'Overall Participants Counts of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'classes': [{'title': 'Participants Reporting At Least One AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Participants Reporting a Severe AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Participants Reporting a Life-threatening AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AE Relation to Drug: Not Related or Probably Not', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AE Relation to Drug: Possibly Related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AE Relation to Drug: Probably or Definitely Relate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 13 months', 'description': 'Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population defined as all participants who received G-CSF and/or plerixafor.'}, {'type': 'SECONDARY', 'title': 'The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'timeFrame': 'Days 5-6', 'description': 'The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).\n\nThis study was terminated early and analysis was not done.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early and analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'timeFrame': '2 months', 'description': 'The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5\\*10\\^9/L for 3 consecutive days or ≥ 1.0\\*10\\^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.\n\nThis study was terminated early and analysis was not done.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early and analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Number of Days to Platelet (PLT) Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'timeFrame': '2 months', 'description': 'The median number of days to platelet (PLT) engraftment criteria was ≥ 20\\*10\\^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.\n\nThis study was terminated early and analysis was not done.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early and analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Graft Durability at 12 Months After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'timeFrame': '13 months', 'description': 'Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.\n\nThis study was terminated early and analysis was not done.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early and analysis was not done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Failed mobilization due to \\<2 fold yield after one day of plerixafor treatment', 'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Failed Mobilization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who had transplants.', 'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study enrollment began in April 2005 and the study was terminated in August 2006. Target enrollment was 15 patients, however the trial was terminated early after five patients were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Diagnosis', 'classes': [{'title': 'Multiple Myeloma (MM)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': "Non-Hodgkin's lymphoma (NHL)", 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': "Hodgkin's disease (HD)", 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'One patient with HD was entered into the study even though there was no indication of MM or NHL (an inclusion criteria).', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Enrollment terminated in 2005 to focus on Phase 3 study enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2006-11-02', 'resultsFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2006-11-02', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-20', 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days', 'timeFrame': 'approximately days 6-9', 'description': 'The number of patients with a circulating CD34+ count \\>= 5 and \\< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\\*10\\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.'}], 'secondaryOutcomes': [{'measure': 'Overall Participants Counts of Adverse Events', 'timeFrame': 'up to 13 months', 'description': 'Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.'}, {'measure': 'The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor', 'timeFrame': 'Days 5-6', 'description': 'The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).\n\nThis study was terminated early and analysis was not done.'}, {'measure': 'Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment', 'timeFrame': '2 months', 'description': 'The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5\\*10\\^9/L for 3 consecutive days or ≥ 1.0\\*10\\^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.\n\nThis study was terminated early and analysis was not done.'}, {'measure': 'Number of Days to Platelet (PLT) Engraftment', 'timeFrame': '2 months', 'description': 'The median number of days to platelet (PLT) engraftment criteria was ≥ 20\\*10\\^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.\n\nThis study was terminated early and analysis was not done.'}, {'measure': 'Graft Durability at 12 Months After Transplantation', 'timeFrame': '13 months', 'description': 'Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.\n\nThis study was terminated early and analysis was not done.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Non-Hodgkin's Lymphoma", 'Multiple Myeloma', 'stem cell mobilization', 'autologous transplantation', 'AMD3100'], 'conditions': ['Multiple Myeloma', "Lymphoma, Non-Hodgkin's"]}, 'descriptionModule': {'briefSummary': "This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\\*10\\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria.\n\nThe purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).", 'detailedDescription': "A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\\*10\\^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis.\n\nFollowing screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the fifth day.\n\nOn Day 5, if the patient's peripheral CD34+ cell count was \\<5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site.\n\nOn Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\\*10\\^6 cells/kg are collected.\n\nOn Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was \\<1.3\\*10\\^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2\\*10\\^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3\\*10\\^6 CD34+ cells/kg, then the patient did not enter the study.\n\nThe next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\\*10\\^6 cells/kg were collected.\n\nAll patients, after the completion of apheresis procedures (or after ≥5\\*10\\^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone.\n\nHematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis.\n\nThis study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (Abbreviated List):\n\n* Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)\n* Eligible for autologous transplantation\n* \\<=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)\n* \\>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)\n* Total dose of melphalan ≦200 mg\n* Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1\n* White blood cell (WBC) count \\>3.0\\*10\\^9/L prior to first dose of G-CSF\n* Absolute polymorphonuclear leukocyte (PMN) count \\>1.5\\*10\\^9/L prior to first dose of G-CSF\n* Platelet (PLT) count \\>100\\*10\\^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF)\n* Serum creatinine ≥2.2 mg/dL\n* SGOT, SGPT and total bilirubin \\<2 times upper limit of normal (ULN)\n* Negative for HIV\n* CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone\n\nExclusion Criteria (Abbreviated List):\n\n* A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications\n* Failed previous stem cell collection or collection attempts\n* A residual acute medical condition resulting from prior chemotherapy\n* Active brain metastases or carcinomatous meningitis\n* Active infection requiring antibiotic treatment\n* Received prior radio-immunotherapy with Zevalin or Bexxar\n* Received bone-seeking radionuclides (e.g., holmium)\n* Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF\n* History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years\n* Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase\n* Had an apheresis yield \\>1.3\\*10\\^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive)."}, 'identificationModule': {'nctId': 'NCT00395967', 'briefTitle': "AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone", 'orgStudyIdInfo': {'id': 'AMD3100-2109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Patients', 'description': 'Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\\*10\\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.', 'interventionNames': ['Drug: G-CSF plus plerixafor']}], 'interventions': [{'name': 'G-CSF plus plerixafor', 'type': 'DRUG', 'otherNames': ['Mozobil', 'AMD3100'], 'description': 'Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.', 'armGroupLabels': ['All Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center - Adult BMT Program', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}