Nctid:
NCT00001561
Payload:
{"FullStudy"=>{"Rank"=>497848, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009101", "ConditionMeshTerm"=>"Multiple Myeloma"}, {"ConditionMeshId"=>"D000054219", "ConditionMeshTerm"=>"Neoplasms, Plasma Cell"}, {"ConditionMeshId"=>"D000006086", "ConditionMeshTerm"=>"Graft vs Host Disease"}]}, "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"=>"M12058", "ConditionBrowseLeafName"=>"Multiple Myeloma", "ConditionBrowseLeafAsFound"=>"Multiple Myeloma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M27588", "ConditionBrowseLeafName"=>"Neoplasms, Plasma Cell", "ConditionBrowseLeafAsFound"=>"Myeloma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9189", "ConditionBrowseLeafName"=>"Graft vs Host Disease", "ConditionBrowseLeafAsFound"=>"Graft vs Host Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21977", "ConditionBrowseLeafName"=>"Hemostatic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5059", "ConditionBrowseLeafName"=>"Blood Coagulation Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17400", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13178", "ConditionBrowseLeafName"=>"Paraproteinemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5077", "ConditionBrowseLeafName"=>"Blood Protein Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9490", "ConditionBrowseLeafName"=>"Hematologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9560", "ConditionBrowseLeafName"=>"Hemorrhagic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11225", "ConditionBrowseLeafName"=>"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10206", "ConditionBrowseLeafName"=>"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3947", "ConditionBrowseLeafName"=>"Multiple Myeloma", "ConditionBrowseLeafAsFound"=>"Multiple Myeloma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T2832", "ConditionBrowseLeafName"=>"Homologous Wasting Disease", "ConditionBrowseLeafAsFound"=>"Graft vs Host Disease", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007136", "InterventionMeshTerm"=>"Immunoglobulins"}, {"InterventionMeshId"=>"D000016756", "InterventionMeshTerm"=>"Immunoglobulins, Intravenous"}, {"InterventionMeshId"=>"D000000906", "InterventionMeshTerm"=>"Antibodies"}, {"InterventionMeshId"=>"D000007130", "InterventionMeshTerm"=>"Immunoglobulin Idiotypes"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10184", "InterventionBrowseLeafName"=>"Immunoglobulins", "InterventionBrowseLeafAsFound"=>"Non-invasive", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19117", "InterventionBrowseLeafName"=>"Immunoglobulins, Intravenous", "InterventionBrowseLeafAsFound"=>"Non-invasive", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4225", "InterventionBrowseLeafName"=>"Antibodies", "InterventionBrowseLeafAsFound"=>"Non-invasive", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17360", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12147", "InterventionBrowseLeafName"=>"Myeloma Proteins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M13179", "InterventionBrowseLeafName"=>"Paraproteins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10178", "InterventionBrowseLeafName"=>"Immunoglobulin Idiotypes", "InterventionBrowseLeafAsFound"=>"Survivin", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"30"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 2005", "CompletionDateStruct"=>{"CompletionDate"=>"September 2005"}, "LastUpdateSubmitDate"=>"September 21, 2007", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"September 24, 2007", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Multiple Myeloma", "Vaccine", "Idiotype-Specific Immunity", "Immune Transfer", "Myeloma Immunoglobulin"]}, "ConditionList"=>{"Condition"=>["Graft vs Host Disease", "Multiple Myeloma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"4108872", "ReferenceType"=>"background", "ReferenceCitation"=>"Sirisinha S, Eisen HN. Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins. Proc Natl Acad Sci U S A. 1971 Dec;68(12):3130-5. doi: 10.1073/pnas.68.12.3130."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"http://clinicalstudies.info.nih.gov/detail/B_1997-C-0030.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used:\n\nABM Allogeneic Bone Marrow\n\nBU Busulfan, NSC-750\n\nCF Leucovorin calcium, NSC-3590\n\nCTX Cyclophosphamide, NSC-26271\n\nG-CSF Granulocyte Colony-Stimulating Factor (source not specified)\n\nGM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795\n\nGVHD Graft-vs.-Host Disease\n\nMesna Mercaptoethane sulfonate, NSC-113891\n\nMTX Methotrexate, NSC-740\n\nPP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150\n\nPP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet hemocyanin\n\nTBI Total-Body Irradiation\n\nTSPA Thiotepa, NSC-6396\n\nRegimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma paraprotein and conjugated with KLH); and PP; with GM-CSF.\n\nRegimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with GM-CSF.", "DetailedDescription"=>"Multiple Myeloma remains a largely incurable disease with current therapy. Allogeneic bone marrow transplantation provides an opportunity to add the potential antitumor effect of marrow grafts to those of high dose chemotherapy. One potential strategy for enhancing a graft vs. tumor effect without aggravating graft vs. host disease would be to selectively target an immune response against a defined tumor-specific antigen. The idiotype of the rearranged immunoglobulin gene product of a myeloma can serve as a unique tumor-specific antigen for vaccine development. We are testing the hypothesis that tumor antigen-specific immunity can be adoptively transferred to BMT recipients by active immunization of marrow transplant donors with purified myeloma idiotype protein, conjugated to a carrier protein (KLH) and administered with GM-CSF as an immunological adjuvant.\n\nPatients under age 60 with an HLA-matched sibling donor, with minimal prior treatment, defined by less than six months prior chemotherapy, and who are in a minimal residual disease state prior to allogeneic BMT, as defined by the achievement of at least a PR, are eligible. HLA matched sibling donors receive a series of three vaccinations during an eight week period prior to bone marrow harvest. Recipients concurrently receive vaccinations pre-BMT, as well as three booster vaccinations at weeks 12, 16, and 24 post-BMT. Id-KLH (0.5 mg) is administered s.c. GM-CSF (250 micrograms/m(2)) is administered s.c. locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination. The objective of this protocol is to induce cellular and humoral immunity in marrow transplant donors and recipients against the unique idiotype expressed by the recipient's myeloma."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPatient Selection:\n\nPatients with IgG or IgA multiple myeloma who attain at least a PR before transplantation are eligible for thsi protocol.\n\nPatients may only have received 3-4 courses of VAD, high dose cyclophosphamide and one autologous transplant before entering the study.\n\nAll previous therapy must be completed at least 2 weeks prior to study entry.\n\nPatients should have recovered from all hematologic and non-hematologic toxicity of previous therapy.\n\nSteroid must be discontinued at least two weeks prior to vaccination.\n\nOnly patients less than 60 years are eligible for this protocol.\n\nPatients must meet the following criteria:\n\nA. Karnofsky performance status greater than or equal to 70 percent.\n\nB. Life expectancy greater than 8 weeks and absence of co-existing medical problems which would significantly increase the risk of the transplant procedure in the judgment of the bone marrow transplant attending physicians (e.g., the MUGA left ventricular ejection fraction has to be greater than 50% and DLCO greater thant 50% of the expected value when corrected for Hb).\n\nCreatinine less than 2x normal and not rising for at least 2-4 weeks before transplantation. If creatinine is elevated, then creatinine clearance must be greater than 40 ml/min.\n\nDirect bilirubin less than 2 mg/dl, SGOT less than 4x top normal, and none of these parameters increasing, for at least 2-4 weeks before transplantation.\n\nPatients must be HIV-negative, HBsAg-, and Hepatitis C antibody Negative.\n\nNot pregnant or lactating. Patients of childbearing potential must use an effective method of contraception.\n\nM-protein concentration in the harvested plasma must be greater than 90 percent of the total Ig of the corresponding isotype.\n\nPatients must be greater than or equal to 18 years old.\n\nDonor criteria:\n\nAny consenting healthy individual who fulfills the donor criteria will be considered for the marrow donation.\n\nHLA-identical sibling donors.\n\nHLA, A and B and DR phenotypically identical family donors.\n\nHIV, hepatitis B or C seropositive.\n\nComplete blood count, platelets, and PT, PTT within normal limits."}, "IdentificationModule"=>{"NCTId"=>"NCT00001561", "BriefTitle"=>"Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970030"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-C-0030"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Myeloma Immunoglobulin Idiotype Vaccine-KLH", "InterventionType"=>"Drug"}, {"InterventionName"=>"GM-CSF", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}