Study on Elranatamab Treatment After Cilta-cel for Patients with High-Risk Relapsed Myeloma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40

ClinicalTrials ID:NCT06947083

This clinical trial is exploring whether the drug Elranatamab can help patients with high-risk relapsed myeloma live longer without their disease getting worse after receiving cilta-cel treatment.

Patient Parameters

Program Overview

The aim of this study is to see if Elranatamab can improve the time patients with high-risk relapsed myeloma live without their cancer progressing, after they have been treated with cilta-cel. High-risk myeloma patients, who have cancer that has spread outside the bones or have certain genetic mutations, often do not benefit as much from cilta-cel alone compared to other patients.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Have received cilta-cel treatment for relapsed myeloma within the last 3-6 months and have high-risk genetic markers or a history of myeloma outside the bones, without signs of disease progression after CAR-T cell therapy.
  • Have had more than two previous treatments, including specific types of drugs like immunomodulatory drugs, proteasome inhibitors, and CD38 monoclonal antibodies.
  • Be able to attend all study visits and follow the study requirements.
  • Must have a clonoseq ID to track minimal residual disease (MRD) status before joining the study.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have normal liver function tests, unless related to Gilbert syndrome.
  • Have adequate bone marrow function.

Exclusion Criteria

  • Have an active infection that is not improving with treatment and requires intravenous antibiotics.
  • Have ongoing symptoms from cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
  • Have active plasma cell leukemia.
  • Have cancer that has spread to the central nervous system, including the brain or spinal cord.
  • Have a history of Guillain-Barre syndrome.
  • Have uncontrolled medical conditions like severe heart, lung, liver, or kidney problems, unless kidney issues are due to myeloma.
  • Be pregnant or breastfeeding.
  • Be using other cancer treatments at the same time.
  • Have active infections with HIV, hepatitis B, or hepatitis C, unless previously treated successfully for hepatitis C or vaccinated for hepatitis B.
  • Require dialysis for kidney failure.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center33612TampaFlorida

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