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

Phase II Study of Elranatamab as Maintenance Therapy Post Ciltacabtagene-autoleucel(Cilta-cel) in Patients With Clinical High Risk Relapsed Myeloma

This study is testing if Elranatamab can help high-risk myeloma patients who have already had cilta-cel live longer without their disease getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Academic / other)
• Drugs / interventions: CAR-T, Elranatamab
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06947083 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with clinical high-risk relapsed myeloma who have received cilta-cel and have specific high-risk cytogenetic features.

Not a fit: Patients with ongoing active infections or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend the time patients with high-risk relapsed myeloma live without disease progression.

How similar studies have performed: While there is ongoing research in this area, the specific combination of Elranatamab post-cilta-cel in high-risk myeloma patients is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Tampa, Florida

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Melissa Alsina, MD — Moffitt Cancer Center
• Study coordinator: Tyler rampersaud

Conditions Myeloma