Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Elranatamab, which is given to patients who have high-risk relapsed myeloma after they have received another therapy called cilta-cel. The main goal of the trial is to see how long patients can live without their myeloma getting worse after receiving Elranatamab. Patients eligible for this trial are those who have had recent treatment with cilta-cel and have specific high-risk features, such as certain genetic changes in their myeloma cells or a history of myeloma spreading outside the bones.

To participate, patients need to be between the ages of 65 and 74, must have had at least two prior treatments for myeloma, and should be in good health overall without any serious infections or other uncontrolled health issues. Participants will be closely monitored throughout the trial for their health and the effectiveness of the treatment. It’s important for potential participants to understand that they will need to sign a consent form and meet specific health criteria to join. This trial is currently recruiting, which means there are opportunities for interested patients to take part.

Gender

ALL

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.