{ "FullStudy":{ "Rank":217719, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517724", "OrgStudyIdInfo":{ "OrgStudyId":"UCL/08/0170" }, "Organization":{ "OrgFullName":"University College, London", "OrgClass":"OTHER" }, "BriefTitle":"Bortezomib Consolidation Trial", "OfficialTitle":"Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma", "Acronym":"BCT" }, "StatusModule":{ "StatusVerifiedDate":"March 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 24, 2019", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 20, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 16, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 17, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University College, London", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Multiple Myeloma" ] }, "KeywordList":{ "Keyword":[ "MM", "HDT", "ASCT", "consolidation", "bortezomib" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Bortezomib consolidation", "ArmGroupType":"Experimental", "ArmGroupDescription":"Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Bortezomib" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Bortezomib", "InterventionDescription":"1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Bortezomib consolidation" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Velcade" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Disease response", "PrimaryOutcomeDescription":"Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.", "PrimaryOutcomeTimeFrame":"At 6 and 12 months after ASCT consolidated by bortezomib therapy" },{ "PrimaryOutcomeMeasure":"Number of patients with adverse events", "PrimaryOutcomeDescription":"The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT", "PrimaryOutcomeTimeFrame":"Up to 8 months after treatment start" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"assess effect of bortezomib consolidation on bone health", "SecondaryOutcomeDescription":"Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption", "SecondaryOutcomeTimeFrame":"At 1, 2, 3 and 9 months after start of treatment" },{ "SecondaryOutcomeMeasure":"assess the effect of bortezomib consolidation on Minimal Residue Disease status", "SecondaryOutcomeTimeFrame":"At 6 and 12 months post ASCT" },{ "SecondaryOutcomeMeasure":"determine progression free survival", "SecondaryOutcomeTimeFrame":"At 2 years post ASCT" },{ "SecondaryOutcomeMeasure":"evaluate the quality of life for patients receiving bortezomib consolidation", "SecondaryOutcomeTimeFrame":"Up to 8 months after treatment start" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed\nAge 18 - 70 years\nLife expectancy > 6 months\nWritten informed consent\nCreatinine < 400µmol/L\nBilirubin < 3x upper limit of normal\nWHO performance status 0-2\nContraceptive precautions where appropriate\n\nExclusion Criteria:\n\nReceived bortezomib previously\nOn, or planned for, steroid therapy\nPoor performance status (ECOG ≥ 3)\nDisease progression at any stage\nPast history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2\nSevere hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST > 2.5x upper limit of normal\nPregnant or lactating women\nAllergic reaction attributable to bortezomib or to compounds containing boron or mannitol\nSevere cardiovascular disease\nHistory of acute infiltrative pulmonary or pericardial disease\nHistory of hypotension or has decreased blood pressure\nPeripheral neuropathy ≥ grade 2, or neuropathic pain\nSerious medical or psychiatric illness likely to interfere with participation in this clinical study\nReceived any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib\nNeed for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors\nHave received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Kwee Yong", "OverallOfficialAffiliation":"University College, London", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University College London", "LocationCity":"London", "LocationCountry":"United Kingdom" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069286", "InterventionMeshTerm":"Bortezomib" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M376", "InterventionBrowseLeafName":"Bortezomib", "InterventionBrowseLeafAsFound":"Bortezomib", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009101", "ConditionMeshTerm":"Multiple Myeloma" },{ "ConditionMeshId":"D000054219", "ConditionMeshTerm":"Neoplasms, Plasma Cell" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000020141", "ConditionAncestorTerm":"Hemostatic Disorders" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000010265", "ConditionAncestorTerm":"Paraproteinemias" },{ "ConditionAncestorId":"D000001796", "ConditionAncestorTerm":"Blood Protein Disorders" },{ "ConditionAncestorId":"D000006402", "ConditionAncestorTerm":"Hematologic Diseases" },{ "ConditionAncestorId":"D000006474", "ConditionAncestorTerm":"Hemorrhagic Disorders" },{ "ConditionAncestorId":"D000008232", "ConditionAncestorTerm":"Lymphoproliferative Disorders" },{ "ConditionAncestorId":"D000007160", "ConditionAncestorTerm":"Immunoproliferative Disorders" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10641", "ConditionBrowseLeafName":"Multiple Myeloma", "ConditionBrowseLeafAsFound":"Multiple Myeloma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M26175", "ConditionBrowseLeafName":"Neoplasms, Plasma Cell", "ConditionBrowseLeafAsFound":"Multiple Myeloma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20561", "ConditionBrowseLeafName":"Hemostatic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3641", "ConditionBrowseLeafName":"Blood Coagulation Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11761", "ConditionBrowseLeafName":"Paraproteinemias", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3659", "ConditionBrowseLeafName":"Blood Protein Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8143", "ConditionBrowseLeafName":"Hemorrhagic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9808", "ConditionBrowseLeafName":"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8789", "ConditionBrowseLeafName":"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T3972", "ConditionBrowseLeafName":"Multiple Myeloma", "ConditionBrowseLeafAsFound":"Multiple Myeloma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }