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

OHSU Knight Cancer Institute

Status: Enrolling

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

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06784167

NCI-2024-10661 (Registry Identifier)

STUDY00027998 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

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.

Treatment:

Other: Non-Interventional Study