Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

18mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach

1 country

7 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.1 years study duration

Study Progress51%

Nov 2024Dec 2027

First Submitted

Initial submission to the registry

October 3, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2027

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

October 3, 2024

Last Update Submit

January 6, 2026

Conditions

Lymphoproliferative Disorder Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

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.
At baseline
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.
At day 90

Secondary Outcomes (1)

Development of myeloid neoplasm post-cytotoxic therapies (MN-pCT)
Up to 2 years

Study Arms (1)

Supportive care (bone marrow aspiration, CFU)

EXPERIMENTAL

Patients undergo bone marrow aspiration and hair, buccal, saliva sample collection up to 14 days prior to LD therapy. Patients undergo CFU on day 90 post-CAR-T therapy. Patients with unexplained cytopenia also undergo bone marrow aspiration for sequencing analysis on day 90 and at development of MN-pCT during CFU. Patients also undergo bone marrow aspiration at determination of clonal evolution or myeloid neoplasm if not done during on day 90.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationOther: Electronic Health Record ReviewProcedure: Follow-UpOther: Genetic CounselingOther: Genetic Testing