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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10661 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00027998 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
PRIMARY OBJECTIVES:
I. 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.
II. 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.
OUTLINE: This is an observational study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preserved immunity | 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. | Up to 12 months after CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antibody titers | 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. | At baseline, at 6 months and at 1 year after vaccination |
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Inclusion Criteria:
* Willingness to provide written informed consent before any study-specific procedures or activities are performed
Exclusion Criteria:
* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints
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Patients with multiple myeloma and non-hodgkin lymphoma recruited through OHSU Knight Cancer Institute
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| Name | Affiliation | Role |
|---|---|---|
| Amrita Desai | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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