Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 3:02 PM
Study NCT ID:
NCT01237951
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2010-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051523', 'term': 'Fibroblast Growth Factor 7'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D005346', 'term': 'Fibroblast Growth Factors'}, {'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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ynieto@mdanderson.org', 'phone': '713-792-2466', 'title': 'Dr. Nieto, Yago, M.D./Stem Cell Transplantation', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 years', 'description': 'All-Cause Mortality was monitored in for all enrolled 75 participants ( 1 participant died before receiving treatment and 4 while on study) and 74 participants with Serious and Other Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Participants with refractory or relapsed myeloma received high-dose GemBuMel with ASCT.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 75, 'otherNumAffected': 71, 'seriousNumAtRisk': 74, 'deathsNumAffected': 5, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 71}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 54}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Hand-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}], 'seriousEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC AE v3.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post-transplant', 'description': 'Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 65 participants had measurable disease at the time of ASCT.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.', 'description': 'Number of participants remain free of progression or death after ASCT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of transplant until the date of death from any cause, assessed up to 2 years', 'description': 'Number of participants from ASCT to death or last contact', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Dying From Treatment-Related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of transplant until the date of death from treatment-related complications, assessed up to 2 years', 'description': 'Participants who died from treatment-related complications from the time of ASCT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at the University of Texas MD Anderson Cancer Center. Out of 75, 1 participant died before starting the treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcitabine/Busulfan/Melphalan', 'description': 'Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Overall study group', 'classes': [{'title': '1st SCT/salvage SCT', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Poor-risk cytogenetics', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Extramedullary disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Double refractory (IMiDs + proteasome inhibitors)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Disease Status: Primary refractory', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Disease Status: Refractory relapse', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Disease Status: Sensitive relapse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Response at ASCT: Response', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Response at ASCT: Refractory', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'No. prior lines of treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'No. prior lines of treatment > 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Post-ASCT maintenance', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-05', 'size': 1052174, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-03T18:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2010-11-08', 'resultsFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-23', 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission', 'timeFrame': '100 days post-transplant', 'description': 'Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.', 'description': 'Number of participants remain free of progression or death after ASCT'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of transplant until the date of death from any cause, assessed up to 2 years', 'description': 'Number of participants from ASCT to death or last contact'}, {'measure': 'Percent of Participants Dying From Treatment-Related Complications', 'timeFrame': 'From date of transplant until the date of death from treatment-related complications, assessed up to 2 years', 'description': 'Participants who died from treatment-related complications from the time of ASCT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Hematopoietic-Cell Support', 'Stem Cell Transplant', 'Busulfan', 'Myleran', 'Busulfex', 'Gemcitabine', 'Gemzar', 'Melphalan', 'Alkeran', 'Decadron', 'Dexamethasone', 'G-CSF', 'Filgrastim', 'Neupogen'], 'conditions': ['Myeloma']}, 'referencesModule': {'references': [{'pmid': '28522110', 'type': 'DERIVED', 'citation': 'Nieto Y, Valdez BC, Pingali SR, Bassett R, Delgado R, Nguyen J, Shah N, Popat U, Jones RB, Andersson BS, Gulbis A, Ahmed S, Bashir Q, Parmar S, Patel K, Myers A, Rondon G, Orlowski RZ, Champlin R, Qazilbash M. High-dose gemcitabine, busulfan, and melphalan for autologous stem-cell transplant in patients with relapsed or refractory myeloma: a phase 2 trial and matched-pair comparison with melphalan. Lancet Haematol. 2017 Jun;4(6):e283-e292. doi: 10.1016/S2352-3026(17)30080-7. Epub 2017 May 15.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.', 'detailedDescription': 'Study Drugs:\n\nBusulfan and melphalan are designed to bind to the DNA (genetic material) of cells, which may cause cancer cells to die. They are commonly used in stem cell transplantation.\n\nGemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.\n\nBusulfan Test Dose:\n\nYou will receive a test dose of busulfan by vein over about 60 minutes. This low-level test dose of busulfan is to check how the level of busulfan in your blood levels changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches your body size. You will most likely receive this as an outpatient during the week before you are admitted to the hospital. If it cannot be given as an outpatient, you will be admitted to the hospital on Day -11 (11 days before your stem cells are returned to your body) and the test dose will be given on Day -10.\n\nAbout 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points and will help the study doctor determine what your dose of busulfan should be on study. These blood samples will be drawn at various timepoints before you receive busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment Day -8. A temporary heparin lock line will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed, you will receive the standard dose of busulfan.\n\nIf you receive the busulfan test dose as an outpatient:\n\nOn Days -12 (12 days before your stem cells are returned to your body) through Day -10, you will receive palifermin by vein over about 30 seconds to help decrease the risk of side effects in the mouth and throat.\n\nYou will be admitted on Day -9 and will receive fluids by vein to hydrate you. You will swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.\n\nOn Days -8 through -5, you will receive busulfan by vein over about 3 hours.\n\nOn Days -8 and -3, you will receive gemcitabine by vein over about 3 hours.\n\nOn Day -4, you will not receive any drugs.\n\nIf you receive the busulfan test dose as an inpatient:\n\nOn Days -13 through Day -11, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.\n\nYou will be admitted on Day -11 and will receive fluids by vein to hydrate you. You will swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.\n\nOn Day -10, you will receive the busulfan test dose by vein over 45 minutes.\n\nOn Day -9, you will not receive any drugs.\n\nOn Days -8 and -3, you will receive gemcitabine by vein over about 3 hours on both days.\n\nOn Days -8 through -5, you will receive busulfan by vein over about 3 hours each day.\n\nStudy Drug Administration (for all patients):\n\nOn Days -9 through -2, you will receive dexamethasone by vein over about 15 minutes to help decrease the risk of the possible side effects of the study drugs.\n\nOn Days -3 and -2, you will receive melphalan by vein over about 30 minutes on both days.\n\nOn Day -1, you will not receive any drugs.\n\nOn Day 0, your stem cells will be returned to your body by vein over 30-60 minutes.\n\nOn Days 0 through 2, you will receive palifermin by vein over about 30 seconds each day.\n\nBeginning on Day 5, you will receive filgrastim (a drug that helps with the growth of white blood cells) through a needle under your skin 1 time each day until your blood cell levels return to normal.\n\nStudy Tests:\n\nWhile you are in the hospital, you will be checked for any side effects as part of your standard of care. Blood (about 2 teaspoons) will be drawn every day to check for side effects.\n\nAs part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are released from the hospital, you must remain in the Houston area to be monitored for infections and other transplant side effects until about Day 30. During this time, you will return to the clinic 1 time each week and the following tests and procedures will be performed:\n\n* You will be asked about how you are feeling and about any side effects you may be having.\n* Blood (about 2 teaspoons) will be drawn for routine tests.\n* You will have a lung function test about 30-100 days after the transplant.\n\nLength of Study:\n\nYou will be followed as part as the study for at least 2 years. You may be taken off study early if the disease gets worse or you experience any intolerable side effects.\n\nAt each follow-up visit the following tests and procedures will be performed:\n\n* Your medical history will be recorded.\n* You will have a physical exam.\n* Blood (about 2 teaspoons) and urine will be collected for routine tests.\n* If your doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease.\n* Bone survey: Only once a year.\n\nYou must talk to the study doctor if you want to leave the study early. It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.\n\nThis is an investigational study. Busulfan, gemcitabine, and melphalan are all FDA approved and commercially available for the treatment of lymphoma, myeloma, and several other tumors. The use of these study drugs together and the use of gemcitabine at the dose level used in this study is investigational.\n\nUp to 75 patients will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Patients with myeloma treated with first-line therapy including lenalidomide, bortezomib or thalidomide, and one or more of the following: 2.1) M paraprotein greater than 1 g/dL at HDC. 2.2) Less than partial response to first-line therapy. 2.3) Relapse after first-line therapy. 2.4) Relapse after a prior autologous stem-cell transplant.\n3. Adequate renal function, as defined by serum creatinine \\</=1.8 mg/dL and/or estimated serum creatinine clearance \\>/=50 ml/min\n4. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \\</=3 x upper limit of normal; serum bilirubin and alkaline phosphatase \\</=2 x upper limit of normal, unless proven to be due to disease involvement.\n5. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \\>/=50% of expected corrected for hemoglobin and/or volume.\n6. Adequate cardiac function with left ventricular ejection fraction \\>/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.\n7. Zubrod performance status \\<2.\n8. Negative Beta human chorionic gonadotropin (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization\n\nExclusion Criteria:\n\n1. Patients with grade \\>/= 3 non-hematologic toxicity from previous therapy that has not resolved to \\</= grade 1.\n2. Patients with prior whole brain irradiation\n3. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \\>/=10,000 copies/mL, or \\>/= 2,000 IU/mL).\n4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.\n5. Active infection requiring parenteral antibiotics.\n6. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts\n7. Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT01237951', 'briefTitle': 'High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'High-dose Gemcitabine, Busulfan and Melphalan With Autologous Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma', 'orgStudyIdInfo': {'id': '2010-0506'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01906', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GemBuMel', 'description': 'Gemcitabine 1875 mg/m\\^2 IV (75 mg/ m2 bolus followed by 1800 mg/m\\^2 over 3 hours) on Day -8 and Day -3 as an outpatient or inpatient.\n\nBusulfan 32 mg/m2 test dose with PKs as outpatient before Day -12, or as an inpatient on Day -10.\n\nBusulfan area under curve (AUC) 4,000 by vein on Days -8 to -5 as an outpatient or inpatient.\n\nMelphalan 60 mg/m\\^2 IV on Days -3 and -2 over 30 minutes on both days as an outpatient or inpatient.\n\nPalifermin 60 micrograms/kg infused as an IVP (by vein) over 15-30 seconds Days -12 to -10 and Days 0 to +2 as an outpatient.\n\nPalifermin 60 micrograms/kg by vein on Days -13 to -11 and on Days 0, +1 and +2 as in inpatient.\n\nDexamethasone 8 mg IV twice a day by vein over 15 minutes Days -9 through -2 as an outpatient or inpatient. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.\n\nStem Cell Transplant: On Day 0, stem cells returned to body by vein over 30-60 minutes.', 'interventionNames': ['Drug: Palifermin', 'Drug: Dexamethasone', 'Drug: Gemcitabine', 'Drug: Busulfan', 'Drug: Melphalan', 'Procedure: Stem Cell Transplant', 'Drug: G-CSF']}], 'interventions': [{'name': 'Palifermin', 'type': 'DRUG', 'otherNames': ['kepivance'], 'description': '60 micrograms/kg infused as an IVP (by vein) over 15-30 seconds Days -12 to -10 and Days 0 to +2 as an outpatient.\n\n60 micrograms/kg by vein on Days -13 to -11 and on Days 0, +1 and +2 as in inpatient.', 'armGroupLabels': ['GemBuMel']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['decadron'], 'description': '8 mg IV twice a day by vein over 15 minutes Days -9 through -2 as an outpatient or inpatient.', 'armGroupLabels': ['GemBuMel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcitabine Hydrochloride', 'Gemzar'], 'description': '1875 mg/m\\^2 IV (75 mg/ m2 bolus followed by 1800 mg/m\\^2 over 3 hours) on Day -8 and Day -3 as an outpatient or inpatient.', 'armGroupLabels': ['GemBuMel']}, {'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['myleran', 'busulfex'], 'description': '32 mg/m2 test dose with PKs as outpatient before Day -12, or as an inpatient on Day -10.\n\nBusulfan AUC 4,000 by vein on Days -8 to -5 as an outpatient or inpatient.', 'armGroupLabels': ['GemBuMel']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran'], 'description': '60 mg/m\\^2 IV on Days -3 and -2 over 30 minutes on both days as an outpatient or inpatient.', 'armGroupLabels': ['GemBuMel']}, {'name': 'Stem Cell Transplant', 'type': 'PROCEDURE', 'otherNames': ['SCT', 'ASCT'], 'description': 'On Day 0, stem cells returned to body by vein over 30-60 minutes.', 'armGroupLabels': ['GemBuMel']}, {'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['Filgrastim', 'Neupogen'], 'description': '5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.', 'armGroupLabels': ['GemBuMel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Yago Nieto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}