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.
Age ≥ 18 years
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined in International Myeloma Working Group (IMWG) criteria or a CD19+ lymphoproliferative disorder (LPD) as defined by 2016 World Health Organization (WHO) classification
Provide written informed consent
Willingness to provide mandatory bone marrow aspirate specimens for correlative research. All bone marrow aspirate samples are collected during a clinical procedure
Ineligible for CAR-T therapy
Patients diagnosed with myeloid neoplasm before CAR-T therapy
Single group
Biospecimen Collection
Procedure/SurgeryUndergo hair, buccal, and saliva sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Electronic Health Record Review
Other interventionAncillary studies
Follow-Up
Procedure/SurgeryUndergo CFU
Genetic Counseling
Other interventionReceive genetic counselor consultation
Genetic Testing
Other interventionUndergo sequencing analysis
Pathogenic and likely pathogenic germline and somatic variants associated with increased risk
The count and percentage of patients with the presence of somatic or germline variants will be reported. The number, type, and function of somatic variants will also be reported.
Unexplained cytopenia
Unexplained cytopenia will be defined per World Health Organization (WHO)-5 as a combination of any of the following: hemoglobin \< 12 g/dL in females, hemoglobin \< 13 g/dL in males, absolute neutrophil count \< 1.8 x 10\^9/L and platelets \< 150 x 10\^9/L. Logistic regression will be used to identify the presence or absence of baseline germline and somatic mutations associated with unexplained cytopenia. An odds ratio and 95% confidence interval will be reported.
Development of myeloid neoplasm post-cytotoxic therapies (MN-pCT)
Assessed as development of MN-pCT at any time following CAR-T infusion. MN-pCT is defined per The World Health Organization- Five Well-Being Index (WHO-5). The count and percentage of patients with the presence of somatic or germline variants will be reported. The number, type, and function of somatic variants will also be reported.
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