Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT00476294
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2007-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow Up Study for AMD3100 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'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': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2007-05-17', 'studyFirstSubmitQcDate': '2007-05-18', 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival at 5 Years', 'timeFrame': '5 Years', 'description': 'Progression-free survival defined as number of participants without disease progression at five years following the first dose of study treatment (placebo or plerixafor \\[AMD3100\\]).'}, {'measure': 'Overall survival at 5 Years', 'timeFrame': '5 years', 'description': 'Overall survival defined as number of participants alive after a period of five years following the first dose of study treatment (placebo or plerixafor \\[AMD3100\\]).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Disease-Free Survival', 'AMD3100', 'G-CSF', 'Autologous Transplantation'], 'conditions': ['Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nThe objective of this long-term observational study is to assess progression-free survival and overall survival for a period of five years following the first dose of study treatment (placebo or plerixafor \\[AMD3100\\]) in protocol AMD3100-3102. Patients that received at least 1 dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind, placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are eligible.', 'detailedDescription': 'Informed Consent Process:\n\nYour study doctor or staff will either meet with you in person or contact you by phone to review the study information. You will be given a copy of this consent form to review and ask questions.\n\nIf you agree to take part in this study, you should sign this consent form on the date that you agree to be in the study. If you agree to take part during a phone call with a member of the study team, you should sign and date the form right away, on the date of the phone call, and mail the form to the study doctor or staff. Please keep a copy for your own reference.\n\n5-Year Follow-Up: You will be contacted by phone or in person at a visit, every 6 months for 5 years from the time of your first study drug/placebo dose in the 2004-0982 study. A placebo is a substance that looks like the study drug but has no active ingredients.\n\nIf you received a transplant in the 2004-0982 study, your first contact in this study will either be about 18 months from the time you began the 2004-0982 study, or at the time you sign this consent form.\n\nIf you did not receive a transplant, your first contact in this study will be at the time you sign this consent form.\n\nAt your first visit or call, you will be asked about the status of the disease, any changes in the multiple myeloma that may have occurred since the 2004-0982 study, and any additional treatments you may have received during that time.\n\nAt every visit or call after that, you will be asked about the status of the multiple myeloma, any changes in the disease, and any treatments you have received since the last visit or call. These questionnaires will take about 10 minutes each time.\n\nYour doctor or the study staff also may contact your local doctor in order to collect information from your medical records or for information about your medical history and disease status.\n\nLength of Study Participation:\n\nYou will be off study after your last study phone call or visit (about 5 years after your first study drug/placebo dose in the 2004-0982 study).\n\nThis is an investigational study. Up to 300 patients will participate in this multi-center study. Up to 12 will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were randomized in a double-blind study and received a stem cell transplant after treatment with AMD3100 and G-CSF OR treatment with Placebo and G-CSF.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT00476294', 'briefTitle': 'Long-Term Follow Up Study for AMD3100 Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Long-Term Observational Follow-Up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 MCG/KG) Plus G-CSF (10 MCG/KG) Versus G-CSF (10 MCG/KG) Plus Placebo to Mobilize and Collect >/= 6 x 10^6 CD34+ Cells/KG in Multiple Myeloma Patients for Autologous Transplantation', 'orgStudyIdInfo': {'id': '2006-0665'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: G + Placebo', 'description': 'G-CSF plus Placebo Arm (G + Placebo)', 'interventionNames': ['Other: Telephone Questionnaire']}, {'label': 'Group 2: G + AMD3100', 'description': 'G-CSF plus AMD3100 Arm (G + AMD3100)', 'interventionNames': ['Other: Telephone Questionnaire']}], 'interventions': [{'name': 'Telephone Questionnaire', 'type': 'OTHER', 'otherNames': ['Survey'], 'description': 'Follow-Up Telephone Calls Every 6 Months for 5 Years.', 'armGroupLabels': ['Group 1: G + Placebo', 'Group 2: G + AMD3100']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Chitra M. Hosing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'AnorMED', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}