Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-01 @ 6:46 AM
Study NCT ID:
NCT06784167
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preserved immunity', 'timeFrame': 'Up to 12 months after CAR-T cell infusion', 'description': 'Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Change in antibody titers', 'timeFrame': 'At baseline, at 6 months and at 1 year after vaccination', 'description': 'Immune reconstitution will be reported based on ELISA assays for S. pneumoniae or tetanus after each dose of respective vaccine for the re-vaccination populations. Will be correlated with the changes of CD4+ and IgG using a Spearman correlation coefficient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Diffuse Large B-Cell Lymphoma', 'Follicular Lymphoma', 'Mantle Cell Lymphoma', 'Multiple Myeloma', 'Primary Mediastinal Large B-Cell Lymphoma', 'Small Lymphocytic Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy.\n\nII. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level.\n\nOUTLINE: This is an observational study.\n\nPatients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multiple myeloma and non-hodgkin lymphoma recruited through OHSU Knight Cancer Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* Willingness to provide written informed consent before any study-specific procedures or activities are performed\n\n * Age ≥ 18 years of age, at the time of consent\n * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed\n * History of prior vaccination against common VPD\n * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days\n * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus\n\nExclusion Criteria:\n\n* \\* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints\n\n * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable'}, 'identificationModule': {'nctId': 'NCT06784167', 'briefTitle': 'Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkins Lymphoma Post CAR-T Treatment', 'orgStudyIdInfo': {'id': 'STUDY00027998'}, 'secondaryIdInfos': [{'id': 'NCI-2024-10661', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00027998', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amrita Desai', 'role': 'CONTACT', 'email': 'desaia@ohsu.edu', 'phone': '503-494-8534'}, {'name': 'Amrita Desai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Amrita Desai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amrita Desai, M.D.', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}