Clinical trial · Interventional
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Marrow Aspiration | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Follow-Up | Procedure | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Genetic Testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (bone marrow aspiration, CFU)
- description
- Patients undergo bone marrow aspiration and hair, saliva, buccal swab, or skin 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 CFU on day 90.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Aspiration
- Other: Electronic Health Record Review
- Procedure: Follow-Up
- Other: Genetic Counseling
- Other: Genetic Testing
Primary outcomes (2)
- measure
- Pathogenic and likely pathogenic germline and somatic variants associated with increased risk
- timeFrame
- At baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Willingness to provide mandatory hair follicle or skin punch biopsy specimens (skin punch biopsy specimens will be obtained from Mayo Clinic Rochester patients only) for correlative research * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willingness to provide mandatory saliva or buccal swab sample for correlative research Exclusion Criteria: * Ineligible for CAR-T therapy * Patients diagnosed with myeloid neoplasm before CAR-T therapy
References
Publications (0)
Data not yet available