Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-04 @ 8:35 AM
Study NCT ID:
NCT00571493
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D002330', 'term': 'Carmustine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmvose@unmc.edu', 'phone': '402-559-3848', 'title': 'Julie M Vose', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I: Intervention', 'description': 'In Phase I of the study, bortezomib will be administered in 4 dose cohorts: .8 mg/m2 , 1.0 mg/m2, 1.3 mg/m2, and1.5 mg/m2. Three patients will be accrued in each dose cohort with enrollment starting at dose cohort 1 (.8 mg/m2). Bortezomib will be given on days -11,-8, -5, and -2. All study patients will receive BEAM conditioning per our standard institution protocol: carmustine (BCNU) 300 mg/m2 on day -5,etoposide 100 mg/m2 twice daily on days -5, -4, -3, and -2, cyatabine100 mg/m2 twice daily on days -5, -4, -3, and -2, and melphalan 140 mg/m2 on day -1 before infusion of autologous stem cells. The objective of phase I is to determine the maximum tolerated dose (MTD) of bortezomib in this setting. After the MTD is defined, another 20 patients will be enrolled in the Phase II portion of this protocol to obtain a preliminary estimate of the response rate.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase II: Survival', 'description': 'Patients enrolled to obtain a preliminary estimate of ORR, Progression-free survival, and overall survival (OS) using this regimen.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Peripheral Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vasovagal syncope/orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'adynamic ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of Bortezomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I', 'description': 'Maximum Tolerated Dose (MTD) of Bortezomib'}, {'id': 'OG001', 'title': 'Phase II', 'description': 'Maximum Tolerated Dose (MTD) of Bortezomib'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 months', 'description': 'The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.', 'unitOfMeasure': 'mg/m²', 'reportingStatus': 'POSTED', 'populationDescription': 'The MTD in Phase I was initially determined to be 1.5 mg/m2 but was later decreased to 1 mg/m2.'}, {'type': 'SECONDARY', 'title': 'Preliminary Estimate of Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Overall Response Rate', 'description': 'To obtain a preliminary estimate of overall response rate (ORR). The overall response rate will be estimated as the number of participants who achieve a complete response (CR) or partial response (PR) divided by the number of evaluable participants.'}], 'classes': [{'title': 'Overall Response Rate (100 days after transplant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Overall Response Rate (1 year after transplant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT', 'description': 'To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One hundred days after autologous hematopoietic stem cell transplantation (ASCT), 40 participants were evaluable for response.\n\nAt year one post ASCT, 38 participants were evaluable for response. Participants evaluable for the secondary endpoints (Phase II) are those who complete the transplant procedure.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS), and Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Progression Free Survival and Overall Survival', 'description': 'To obtain a preliminary estimate of progression free survival (PFS), and overall survival (OS)'}], 'classes': [{'title': 'Progression Free Survival 1 year after transplant', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '92'}]}]}, {'title': 'Overall Survival 1 year after transplant', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '96'}]}]}, {'title': 'Progression Free Survival 5 years after transplant', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '51'}]}]}, {'title': 'Overall Survival 5 years after transplant', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT', 'description': 'To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 38 evaluable patients at one year post autologous hematopoietic stem cell transplantation (ASCT).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Bortezomib-0.8 mg/m²', 'description': 'Bortezomib dose - 0.8 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).'}, {'id': 'FG001', 'title': 'Phase 1: Bortezomib-1.0 mg/m²', 'description': 'Bortezomib dose - 1.0 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).'}, {'id': 'FG002', 'title': 'Phase 1: Bortezomib-1.3 mg/m²', 'description': 'Bortezomib dose - 1.3 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).'}, {'id': 'FG003', 'title': 'Phase 1: Bortezomib-1.5 mg/m²', 'description': 'Bortezomib dose - 1.5 mg/m² will be added to standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) regimen followed by autologous hematopoietic stem cell transplantation (ASCT).'}, {'id': 'FG004', 'title': 'Phase II: Bortezomib-1.5 mg/m²', 'description': 'Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.'}, {'id': 'FG005', 'title': 'Phase II: Bortezomib-1.3 mg/m²', 'description': 'Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.'}, {'id': 'FG006', 'title': 'Phase II:Bortezomib-1.0 mg/m²', 'description': 'Obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with maximum tolerated dose regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled at an academic medical center in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I/II', 'description': 'In Phase 1 of the study, bortezomib was administered in 4 dose cohorts: 0.8 mg/m², 1.0 mg/m², 1.3 mg/m² and 1.5 mg/m². Bortezomib was given on days -11, -8, -5, and -2. All study patients received BEAM conditioning: carmustine (BCNU) 300 mg/m² on day -5, etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2, cytarabine 100 mg/m² twice daily on days -5, -4, -3, and -2, and melphalan 140 mg/m² on day -1 before infusion of autologous stem cells. The objective of phase 1 was to determine the maximum tolerated dose (MTD) of bortezomib in this setting. The MTD was defined by observing any nonhematologic transplantation-related toxicity higher than grade 2 on the Bearman scale occurring between day -11 and engraftment. After the MTD was defined, patients were enrolled in Phase II to obtain a preliminary estimate of overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) using this regimen.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2007-12-11', 'resultsFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-29', 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of Bortezomib', 'timeFrame': '14 months', 'description': 'The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.'}], 'secondaryOutcomes': [{'measure': 'Preliminary Estimate of Overall Response Rate (ORR)', 'timeFrame': '100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT', 'description': 'To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients.'}, {'measure': 'Progression-free Survival (PFS), and Overall Survival (OS)', 'timeFrame': 'one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT', 'description': 'To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["non-hodgkin's lymphoma", 'mantle cell lymphoma', 'BEAM', 'Velcade'], 'conditions': ["Non-hodgkin's Lymphoma", 'Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.', 'detailedDescription': 'Primary Objective:The primary objective of the study is to evaluate the toxicity and determine the maximum tolerated dose (MTD) of bortezomib when added to a standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) conditioning regimen followed by autologous hematopoietic stem cell transplantation (ASCT).\n\nSecondary Objective: The secondary objective of the study is to obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with this regimen.\n\nEnrolled subjects will receive bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (AHSCT). Phase I treatment will administer bortezomib in four dose cohorts,in addition to the BEAM and ASCT. Three patients will be accrued in each dose cohort with enrollment starting at dose cohort. These subjects will be evaluated to establish the maximum tolerated dose of bortezomib in combination with BEAM autologous peripheral blood stem cell transplantation. Once established, the maximum tolerated dose will be utilized in treating an additional 20 subjects.\n\nFollow-Up: Data collected will be utilized to obtain a preliminary estimate of the overall response rate, progressions free survival and overall survival using this regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Persistent, relapsed or refractory indolent non-Hodgkin's lymphoma (Follicular grade I, II, or III), non-Hodgkin's lymphoma, composite lymphomas with ≥ 50% of tumor showing follicular histology, transformed follicular, lymphoplasmacytic, marginal zone lymphoma, small Lymphocytic Lymphoma (including T-cell subtypes), or mantle cell lymphoma that is relapsed, refractory, or in PR1 or CR1 (MCL only for CR1).\n* Age \\>19 years.\n* Signed written informed consent.\n* Expected survival duration of \\> six months.\n* Karnofsky Performance Status \\> 70.\n* Eligible patients must have: Liver functions \\< 3x upper limits of normal (ULN) unless due to disease; ANC \\> 500 cells/mm3 and Platelet Count \\> 50 mm3.\n* Patients \\> age 60 or with clinical signs of heart disease must have ejection fraction ≥ 45% LVEF.\n* Patients with clinical signs of pulmonary insufficiency must have DLCO to be measured at \\> 50% of predicted value.\n* Able to collect \\> 1.2 X 106/kg CD34+ cell for transplantation.\n* No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study.\n* Female patients must not be pregnant or lactating.\n* Male and female patients of reproductive potential must follow accepted birth control measures.\n\nExclusion Criteria:\n\n* Patients who are HIV seropositive\n* Serum creatinine \\>2.5mg/dL or calculated creatinine clearance ≤ 50ml/min\n* Total bilirubin \\>3 times upper limits of normal (unless due to Gilberts disease or malignancy), ALT and AST \\>4 times the upper limits of normal\n* Active infection at the time of transplant\n* Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.\n* Patient has hypersensitivity to bortezomib, boron or mannitol.\n* Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women."}, 'identificationModule': {'nctId': 'NCT00571493', 'briefTitle': "VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': "Phase I/II Study of VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Indolent Non-Hodgkin's Lymphoma, Transformed or Mantle Cell Lymphoma", 'orgStudyIdInfo': {'id': '0438-05-FB'}, 'secondaryIdInfos': [{'id': 'Protocol# X05184', 'type': 'OTHER_GRANT', 'domain': 'Millennium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bortezomib Dose Escalation', 'description': 'The phase I section of the study will follow a standard 3 + 3 design to determine the maximum tolerated dose (MTD) of bortezomib when added to a standard BEAM (BCNU (carmustine), etoposide, cytarabine, melphalan) conditioning regimen followed by autologous hematopoietic stem cell transplantation (ASCT).\n\nAfter the MTD is defined, additional patients will enroll in Phase II to obtain preliminary estimates of survival using the Phase I regimen.', 'interventionNames': ['Drug: Bortezomib', 'Drug: BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Patients will receive bortezomib in four dose cohorts ( .8. 1.0, 1.3, 1.5 mg/m²). Patients will receive bortezomib on days -11, -8, -5, and -2 before infusion of autologous stem cells.', 'armGroupLabels': ['Bortezomib Dose Escalation']}, {'name': 'BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)', 'type': 'DRUG', 'otherNames': ['B - Carmustine (BCNU) E - Etoposide. A - Cytarabine (Ara-C, cytosine arabinoside) M - Melphalan'], 'description': 'All study patients will receive BEAM per the standard institution protocol:\n\nBCNU (carmustine): 300 mg/m²on day -5 etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2 cytarabine 100 mg/m² twice daily on days -5, -4, -3, -2 melphalan: 140 mg/m² on day -1 before infusion of autologous stem cells.', 'armGroupLabels': ['Bortezomib Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Julie M Vose, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}