Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2027-04-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia Diffuse Large B-Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Multiple Myeloma Primary Mediastinal Large B-Cell Lymphoma Small Lymphocytic Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \* Willingness to provide written informed consent before any study-specific procedures or activities are performed

* Age ≥ 18 years of age, at the time of consent
* 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
* History of prior vaccination against common VPD
* Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days
* Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus

Exclusion Criteria

* \* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No