Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT01045460
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'C048042', 'term': 'N(1)-methyl-2-lysergic acid diethylamide'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D007937', 'term': 'Leukapheresis'}, {'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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'}, {'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': 'D016238', 'term': 'Cytapheresis'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D047589', 'term': 'Leukocyte Reduction Procedures'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'iborrell@jhmi.edu', 'phone': '4109554967', 'title': 'Ivan Borrello, MD', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'description': 'All adverse events related to MILs or vaccine administration were collected. Adverse events related to ASCT were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 40, 'numAffected': 14}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rates by Blade Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'nCR', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'VGPR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'MR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ORR', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants with each disease response category utilizing the Blade criteria:\n\n* Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with \\< 5% plasma cells.\n* Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with \\< 5% plasma cells.\n* Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein \\< 100 mg/24 hours.\n* Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein.\n* Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein.\n* Stable Disease (SD): Defined as not falling into any other response category.\n* Overall response rate (ORR): Total of CR, nCR, VGPR, and PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '37'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Median number of months that participants were alive without disease relapse or progression (progression-free survival).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Number of participants alive at 5 years (overall survival).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Feasibility as Measured by Participant Withdrawal or Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety as Measured by Grade 3-5 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to MILs or the myeloma vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-tumor Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, and 360', 'description': '* Evaluate tumor specific responses in blood and bone marrow\n* Examine T cell responses to DC-pulsed myeloma cell lines\n* Examine induction of novel antibody responses', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, and 360', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, 360', 'description': 'Serum C Telopeptide', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, 360', 'description': 'bAlkaline phosphatase', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, 360', 'description': 'Osteocalcin', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'Effect of aMILs on Clonogenic Myeloma Precursors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'OG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'timeFrame': 'Days 60, 180, and 360', 'description': '• Examine side population of CD19 enriched PBLs throughout study.', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not assessed. Data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2 and -1.\n\nAutologous stem cell transplant: Infused on Day 0.'}, {'id': 'FG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.\n\nActivated marrow infiltrating lymphocytes: Administered on Days 3 and 4.\n\nAllogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.\n\nCyclophosphamide: Administered at 2.5 g/m\\^2.\n\nFilgrastim: Administered post cyclophosphamide daily until leukapheresis.\n\nLeukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.\n\nMelphalan: 100 mg/m\\^2/day given on Days -2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One subject was a screen failure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.'}, {'id': 'BG001', 'title': 'ASCT + MILs + Vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '69'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '72'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International Staging System (ISS) stage', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Stage unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '* Stage 1: Beta-2 microglobulin \\< 3.5 mg/L and serum albumin \\>= 3.5 g/dL.\n* Stage 2: Neither stage 1 nor stage 3.\n* Stage 3: Beta-2 microglobulin \\>= 5.5 mg/L.\n\nHigher beta-2 microglobulin reflects greater tumor mass. Therefore, a higher stage reflects a worse prognosis.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-08-06', 'size': 1731969, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-05T10:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2009-12-14', 'resultsFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-19', 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rates by Blade Criteria', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants with each disease response category utilizing the Blade criteria:\n\n* Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with \\< 5% plasma cells.\n* Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with \\< 5% plasma cells.\n* Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein \\< 100 mg/24 hours.\n* Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein.\n* Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein.\n* Stable Disease (SD): Defined as not falling into any other response category.\n* Overall response rate (ORR): Total of CR, nCR, VGPR, and PR.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Up to 5 years', 'description': 'Median number of months that participants were alive without disease relapse or progression (progression-free survival).'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 5 years', 'description': 'Number of participants alive at 5 years (overall survival).'}, {'measure': 'Feasibility as Measured by Participant Withdrawal or Removal', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion.'}, {'measure': 'Safety as Measured by Grade 3-5 Adverse Events', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to MILs or the myeloma vaccine.'}, {'measure': 'Anti-tumor Immune Response', 'timeFrame': 'Days 60, 180, and 360', 'description': '* Evaluate tumor specific responses in blood and bone marrow\n* Examine T cell responses to DC-pulsed myeloma cell lines\n* Examine induction of novel antibody responses'}, {'measure': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)', 'timeFrame': 'Days 60, 180, and 360'}, {'measure': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)', 'timeFrame': 'Days 60, 180, 360', 'description': 'Serum C Telopeptide'}, {'measure': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)', 'timeFrame': 'Days 60, 180, 360', 'description': 'bAlkaline phosphatase'}, {'measure': 'The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)', 'timeFrame': 'Days 60, 180, 360', 'description': 'Osteocalcin'}, {'measure': 'Effect of aMILs on Clonogenic Myeloma Precursors', 'timeFrame': 'Days 60, 180, and 360', 'description': '• Examine side population of CD19 enriched PBLs throughout study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': "Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant.\n\nNumber of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant.\n\nStudy Objectives:\n\nDisease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year.\n\nAdditional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Durie-Salmon Stage II or III multiple myeloma\n* Newly diagnosed either prior to receiving treatment or having completed induction therapy\n* Relapsed myeloma not previously transplanted within the past 5 years\n* Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable\n* Age greater than 18 years old\n* ECOG performance status of 0 - 2\n* Meet all institutional requirements for autologous stem cell transplantation\n* The patient must be able to comprehend and have signed the informed consent\n\nExclusion Criteria:\n\n* Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \\[M-protein\\] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)\n* Plasma cell leukemia\n* Amyloidosis\n* Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection\n* Use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine\n* In a complete remission at the time of bone marrow collection\n* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection\n* Participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device\n* History of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer\n* Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted\n* Evidence of spinal cord compression at time of transplant"}, 'identificationModule': {'nctId': 'NCT01045460', 'acronym': 'aMILs', 'briefTitle': 'Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma', 'orgStudyIdInfo': {'id': 'J0997'}, 'secondaryIdInfos': [{'id': 'NA_00029491', 'type': 'OTHER', 'domain': 'JHMIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASCT + MILs', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.', 'interventionNames': ['Biological: Activated marrow infiltrating lymphocytes', 'Drug: Cyclophosphamide', 'Biological: Filgrastim', 'Procedure: Leukapheresis', 'Drug: Melphalan', 'Biological: Autologous stem cell transplant']}, {'type': 'EXPERIMENTAL', 'label': 'ASCT + MILs + vaccine', 'description': 'Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.', 'interventionNames': ['Biological: Activated marrow infiltrating lymphocytes', 'Biological: Allogeneic Myeloma Vaccine', 'Drug: Cyclophosphamide', 'Biological: Filgrastim', 'Procedure: Leukapheresis', 'Drug: Melphalan', 'Biological: Autologous stem cell transplant']}], 'interventions': [{'name': 'Activated marrow infiltrating lymphocytes', 'type': 'BIOLOGICAL', 'otherNames': ['MILs', 'aMILs'], 'description': 'Administered on Days 3 and 4.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}, {'name': 'Allogeneic Myeloma Vaccine', 'type': 'BIOLOGICAL', 'description': 'Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.', 'armGroupLabels': ['ASCT + MILs + vaccine']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Administered at 2.5 g/m\\^2.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF'], 'description': 'Administered post cyclophosphamide daily until leukapheresis.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}, {'name': 'Leukapheresis', 'type': 'PROCEDURE', 'otherNames': ['Apheresis'], 'description': 'Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran'], 'description': '100 mg/m\\^2/day given on Days -2 and -1.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}, {'name': 'Autologous stem cell transplant', 'type': 'BIOLOGICAL', 'otherNames': ['ASCT'], 'description': 'Infused on Day 0.', 'armGroupLabels': ['ASCT + MILs', 'ASCT + MILs + vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ivan Borrello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}