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Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)

NCT06630104 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-01-08

No results posted yet for this study

Summary

This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene mutations may help identify the risk of cytopenia in patients with multiple myeloma or CD19 positive LPD following CAR-T therapy.

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo hair, buccal, and saliva sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Follow-Up

Undergo CFU

OTHER

Genetic Counseling

Receive genetic counselor consultation

OTHER

Genetic Testing

Undergo sequencing analysis

Sponsors & Collaborators

Principal Investigators

  • Mithun V. Shah, MD · Mayo Clinic in Rochester

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2027-12-16
Completion
2027-12-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630104 on ClinicalTrials.gov