Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT00090493
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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': 'C072013', 'term': 'MAGEA3 protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vanrheefrits@uams.edu', 'phone': '(501) 686-8230', 'title': 'Frits van Rhee, MD, PhD', 'organization': 'University of Arkansas for Medical Sciences - MIRT'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY', 'description': 'Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.\n\nMAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.\n\nMAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphyloccocal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Experiencing a Response to the Peptide Vaccines.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY', 'description': 'Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.\n\nMAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.\n\nMAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 week intervals', 'description': 'The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only 2 were complete per protocol. 2 were withdrawn by physician due to relapse.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY', 'description': 'Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.\n\nMAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.\n\nMAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'All patients of the Myeloma Institute who have "high-risk" multiple myeloma because of abnormalities in their cytogenetics, could participate in this study at UAMS only. Final IRB approval was 6/14/04. The 1st participant was enrolled 4/4/05.', 'preAssignmentDetails': 'Pre-study: hemogram, blood chemistry, Helper/Suppressor Panel, Immunoknow count, serum protein electrophoresis and immunofixation , serum freelites, 24-hr urine (protein and immunofixation), quantitation of immunoglobulins, B2M, IL6, bone marrow aspiration and biopsy, MRI, bone marrow collection for gene-array.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY', 'description': 'Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2004-08-26', 'resultsFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2004-08-30', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-16', 'studyFirstPostDateStruct': {'date': '2004-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Experiencing a Response to the Peptide Vaccines.', 'timeFrame': '2 week intervals', 'description': 'The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myeloma', 'Mage-A3', 'Transplant', 'Peptide', 'DTPACE', 'vaccines', 'Immunotherapy', 'NY-ESO-1'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://myeloma.uams.edu/', 'label': 'Myeloma Institute for Research \\& Therapy website'}]}, 'descriptionModule': {'briefSummary': 'The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.', 'detailedDescription': 'This is an experimental treatment that will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.\n\nThe peptides are fragments from two tumor proteins called MAGE-A3 and NY-ESO-1. In order to be eligible for the study your myeloma cells must express either MAGE-A3 or NY-ESO-1, and your myeloma must be severe enough to require chemotherapy and stem cell transplantation. You must also have the appropriate HLA tissue type.\n\nPatients who have MAGE-A3 positive myeloma and are HLA-A\\*0101 or -B\\*35 positive will receive the MAGE-A3 peptide vaccine.\n\nPatients who have NY-ESO-1 positive myeloma and are HLA-A\\*0201 will receive the NY-ESO-1 peptide vaccine.\n\nThree injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.\n\nYour myeloma cells, obtained from a routine bone marrow aspirate, will be tested in the laboratory for the presence of MAGE-A3 and/or NY-ESO-1 proteins. HLA tissue type will be determined by standard methods in our Clinical Laboratory. This allows allocation of the correct vaccine to each individual patient.\n\nPrior to starting a 6-day course of chemotherapy called DTPACE, white blood cells will be collected by a procedure called leukapheresis (leukapheresis no.1). Your white blood cells will be frozen for the duration of the chemotherapy in order to protect these white blood cells from the harmful effects of chemotherapy. After the chemotherapy is given, stem cells will be collected by leukapheresis (PBSC collection) and stored until the time of transplantation. After a short period of rest, the white blood cells from leukapheresis no.1 will be thawed and re-infused. This will ensure that you will have white blood cells that are in the best possible condition to respond to the peptide vaccines. A set of three vaccinations with the peptides at two-week intervals will follow. The hope is that the vaccinations will have generated precious anti-myeloma white blood cells.\n\nYou will again undergo leukapheresis (leukapheresis no.2) to collect the anti-myeloma white blood cells, which will be frozen in order to protect these precious cells from the chemotherapy drugs that will be infused just before the single or double auto-transplant.\n\nA single dose of Melphalan will precede each transplant. The stem cells that were collected after DTPACE will be given for the transplants. For those receiving two transplants, a regimen of thalidomide with dexamethasone will be given for approximately 10 weeks between the two transplants. You will stop your thalidomide 28 days before the second transplant.\n\nAfter completion of the transplants, the anti-myeloma white blood cells collected with leukapheresis no. 2 will be thawed and re-infused. These anti-myeloma cells will be boosted by three further peptide vaccinations at two-week intervals.\n\nFinally, after you have completed these three vaccinations you will undergo another leukapheresis (no. 3). The anti-myeloma white blood cells collected with leukapheresis no. 3 will be frozen and stored for possible future use.\n\nSix final vaccines will be given at monthly intervals to further amplify the anti-myeloma white blood cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MM patients who have active, symptomatic myeloma, and meet the criteria below thus establishing the presence of high-risk myeloma\n* MM Salmon-Durie Stage: IA\\&B (with abnormal cytogenetics\\*), IIA, IIB, IIIA, and IIIB, and meet the criteria below thus establishing the presence of high-risk myeloma\n* MM must meet one of the following criteria: a) Patients who have MAGE-A3 positive MM and who have the tissue type HLA-A\\*0101, or -\\* B35, are allocated to receive the MAGE-A3168-176 peptide vaccine. b) Patients who have NY-ESO-1 positive MM and who have the tissue type HLA-A\\*0201 are allocated to the NY-ESO-1156-C165V peptide vaccine. c) Patients who have NY-ESO-1 positive and MAGE-A3 negative or positive MM and who have as tissue type HLA-A\\*0101, or -\\* B35 and HLA-A\\*0201, will receive vaccination with the NY-ESO-1156-C165V peptide vaccine. d) Patients who have NY-ESO-1 negative and MAGE-A3 positive MM and who have as tissue type HLA-A\\*0101, or -\\* B35 and HLA-A\\*0201, will receive vaccination with the MAGE-A3 peptide vaccine.\n* Karnofsky performance score ≥=70, unless bone pain caused by MM results in a Karnofsky score of \\> or =50.\n* Age 18-70 years old\n* Hb \\> or =8.0gm/dl, ANC \\> or =1,000/microliters, platelet count \\> or = 100,000/microliters.\n* Patients must have signed an IRB-approved consent form and been informed about the investigational nature of the study\n* Negative serology for HIV, Hepatitis C and negative for Hepatitis B surface antigen.\n* CD4+ count \\>400/microliters\n* Life expectancy \\> 6 months\n* Negative pregnancy test and females agree to two forms of contraception or abstinence.\n* Provisional insurance approval for single or double auto-transplant(s)\n\nExclusion Criteria:\n\n* MGUS, indolent and smoldering myeloma\n* Chemotherapy or other immunosuppressive treatment e.g. gluco-corticosteroids, cyclophosphamide, methotrexate within the 4 weeks prior to enrollment\n* Patients who have malignancies other than carcinoma-in-situ of the cervix or non-melanomatous skin cancer\n* Fever or active infection\n* Liver function: total bilirubin \\> 2.5xULN or AST/ALT \\>2.5xULN\n* Renal function: patients on dialysis, or serum creatinine \\>2.0mg/dl\n* Simultaneous treatment with a second investigational drug or biologic agent for MM\n* Other intercurrent serious illness, e.g. cardiac, pulmonary, hepatic disease, uncontrolled diabetes, etc\n* Cardiac: Patients with recent (\\< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or must be \\> or = 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated\n* Pulmonary: Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease resulting in unacceptable lung function: patients must have adequate pulmonary function studies \\> or = 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \\> or = 50% of predicted. Patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70\n* Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: A) Patients that have received prior adriamycin \\> 450 mg/m2 and LVEF \\< 55%. Adriamycin will be omitted in these patients. B) Patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose'}, 'identificationModule': {'nctId': 'NCT00090493', 'briefTitle': 'Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'UARK 2003-26, A Pilot Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combination With DTPACE Chemotherapy and Autologous Transplantation in Multiple Myeloma', 'orgStudyIdInfo': {'id': 'UARK 2003-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAGE-A3 and NY-ESO-1 Immunotherapy', 'description': 'Treatment will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). Peptides are small pieces of proteins. We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.', 'interventionNames': ['Biological: MAGE-A3', 'Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY']}], 'interventions': [{'name': 'MAGE-A3', 'type': 'BIOLOGICAL', 'description': 'vaccinations at 2- week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating the patient 3 times at 14 day intervals (vaccination #4-6: days 82, 96, and 110). Vaccines #4-6 will be identical to vaccines 1-3. Thereafter, 6 monthly vaccines will be given to further boost the anti-MM-T-cells.', 'armGroupLabels': ['MAGE-A3 and NY-ESO-1 Immunotherapy']}, {'name': 'MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY', 'type': 'BIOLOGICAL', 'description': 'Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals', 'armGroupLabels': ['MAGE-A3 and NY-ESO-1 Immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences/MIRT', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Frits van Rhee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Myeloma Institute for Research & Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}