Elranatamab treatment after cilta-cel for high-risk relapsed myeloma patients

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 study evaluates the effectiveness of Elranatamab therapy in patients with clinical high-risk relapsed myeloma who have previously received cilta-cel. The primary focus is on measuring progression-free survival (PFS), which indicates how long patients can live without their myeloma worsening. Eligible participants must have specific high-risk characteristics and must not show evidence of disease progression after CAR-T cell therapy. The study aims to provide insights into improving outcomes for this challenging patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Understand and voluntarily sign an informed consent form.
* Have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma and have high risk cytogenetics by IMW (del17p, or t(4;14) or t(14;16) or history of EMD, and must not have evidence of progressive disease by IMWG criteria(Appendix B) following CAR-T cell therapy.
* Have received \>2 prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor and a CD38 monoclonal antibody.
* Able to adhere to the study visit schedule and other protocol requirements.
* Patients must have available clonoseq ID prior to enrollment to track MRD status.
* Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
* Serum bilirubin levels ≤1.5 times the upper limit of the normal range for the laboratory (ULN), unless related to Gilbert syndrome.
* Serum AST or serum ALT levels ≤2 x ULN.
* Must have adequate bone marrow function.

Exclusion Criteria:

* Ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment.
* Ongoing CRS or ICANS of any grade.
* Active plasma cell leukemia.
* Patients with CNS involvement, including meningeal involvement.
* Patients with history of Guillain-Barre syndrome.
* Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma, which in the opinion of the treating physician pose an unacceptable risk to the patient.
* Pregnant or lactating females.
* Concurrent use of other anti-cancer agents or treatments.
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Note: patients with hepatitis C previously treated with curative intent are considered eligible.
* Patients with renal failure requiring dialysis.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Melissa Alsina, MD — Moffitt Cancer Center
• Study coordinator: Tyler rampersaud
• Email: Tyler.Rampersaud@moffitt.org
• Phone: 813-745-8272

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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.