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

Conditions

• Lymphoproliferative Disorder
• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo hair, buccal, and saliva sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Electronic Health Record Review — OTHER
  Ancillary studies
• Follow-Up — PROCEDURE
  Undergo CFU
• Genetic Counseling — OTHER
  Receive genetic counselor consultation
• Genetic Testing — OTHER
  Undergo sequencing analysis

Study Details

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.

Key Dates

Start date

Nov 22, 2024

Status verified

Jan 2026

Primary completion

Dec 16, 2027

Completion

Dec 16, 2027

Study Design

Enrollment

82 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Supportive care (bone marrow aspiration, CFU)
  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.

Primary Outcome Measure

Pathogenic and likely pathogenic germline and somatic variants associated with increased risk [ Time Frame: At baseline ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]

Locations (7)

Find similar trials in Scottsdale, AZ

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