Study on Using Elranatamab for Personalized Maintenance After Transplant in Multiple Myeloma Patients
Sponsor: Washington University School of Medicine
Sponsor score: 40
ClinicalTrials ID:NCT06483100
This clinical trial is exploring a personalized treatment approach using the drug elranatamab, guided by specific blood tests, for patients with newly diagnosed multiple myeloma who have undergone a stem cell transplant.
Patient Parameters
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Program Overview
The study aims to test a personalized treatment plan for patients with newly diagnosed multiple myeloma who have had a stem cell transplant. It uses a drug called elranatamab and special blood tests to check for any remaining cancer cells. The goal is to see if this approach can help maintain the patient's health after the transplant.
Eligibility Criteria
Inclusion Criteria
- Have undergone a stem cell transplant as part of initial treatment for newly diagnosed IgG or IgA multiple myeloma.
- Received initial treatment with at least three drugs, including a proteasome inhibitor and an immunomodulatory drug, with or without an anti-CD38 antibody.
- Showed at least a partial response to treatment at the time of study screening after the transplant.
- Tested positive for minimal residual disease (MRD) 100 days after the transplant, indicating some remaining cancer cells.
- Have a performance status score of 2 or less, meaning fully active or able to carry out light work.
- Have resolved any side effects from previous treatments to a mild level before joining the study.
- Have adequate blood and organ function, including:
- Platelet count of at least 75,000 per microliter.
- Neutrophil count of at least 1,000 per microliter.
- Hemoglobin level of at least 8 g/dL without recent transfusions.
- Normal liver and kidney function as indicated by specific blood tests.
- Agree to use effective contraception during the study and for 5 months after treatment, if of childbearing potential.
Exclusion Criteria
- Cannot identify a specific marker for tracking the disease.
- Have had another cancer, except for certain skin or prostate cancers, unless treatment was completed over 2 years ago with no signs of disease.
- Currently taking other experimental treatments.
- Have had previous treatment targeting BCMA.
- Have cancer that has spread to the brain or spinal cord.
- Have had severe allergic reactions to similar drugs as elranatamab.
- Have uncontrolled illnesses, such as plasma cell leukemia or active infections.
- Are pregnant or breastfeeding. Women must have a negative pregnancy test before starting treatment.
- Have HIV unless on effective treatment with an undetectable viral load for at least 6 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
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