Study on Elranatamab Treatment After Cilta-cel for Patients with High-Risk Relapsed Myeloma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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