Understanding blood cell issues after CAR-T therapy for multiple myeloma or lymphoproliferative disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how genetic variations in patients with multiple myeloma or CD19 positive lymphoproliferative disorder affect the risk of developing cytopenia after receiving CAR-T therapy. The study involves collecting bone marrow, hair, buccal, and saliva samples to analyze preexisting and therapy-emergent genetic variants. Patients will be monitored for cytopenia and undergo follow-up assessments for up to two years to evaluate the impact of these genetic factors. The goal is to identify gene mutations that may help predict the risk of prolonged cytopenia following treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic Health System in Albert Lea
  Albert Lea, Minnesota, United States Recruiting
• Mayo Clinic Health System-Mankato
  Mankato, Minnesota, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic Health System-Eau Claire Clinic
  Eau Claire, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Mithun V. Shah, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.