Study on mRNA-2808 for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: ModernaTX, Inc.
Sponsor score: 0
ClinicalTrials ID:NCT07116616
This clinical trial is testing the safety and tolerability of a new treatment, mRNA-2808, for patients with multiple myeloma that has returned or is not responding to previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to determine if the new treatment, mRNA-2808, is safe and well-tolerated in patients who have multiple myeloma that has either come back after treatment or has not responded to standard therapies.
Eligibility Criteria
Inclusion Criteria
- Have multiple myeloma that has returned or is not responding to treatment.
- Have previously been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
- Have measurable disease, which can be shown by one of the following:
- M-protein in the blood of at least 0.5 grams per deciliter.
- M-protein in the urine of at least 200 milligrams in a 24-hour period.
- Free light chain in the blood of at least 100 milligrams per liter with an abnormal ratio.
- A plasmacytoma (a type of tumor) that is at least 2 centimeters in size.
- Bone marrow plasma cells greater than 30%.
Exclusion Criteria
- Have myeloma that has spread to the brain or symptoms suggesting brain involvement.
- Have active plasma cell leukemia, which means having a high number of plasma cells in the blood.
- Have received radiation or chemotherapy within 2 weeks before starting the study, except for limited radiation for symptom relief after discussion with the study team.
- Have received antibody-based treatments within 21 days before starting the study.
- Have taken proteasome inhibitors or immunomodulatory drugs within 14 days before starting the study.
- Have had an autologous stem cell transplant within 100 days before starting the study.
- Have had an allogeneic stem cell transplant within 180 days before starting the study.
- Have had genetically modified cell therapy, like CAR-T cell therapy, within 12 weeks before starting the study.
- Have taken high doses of corticosteroids within 14 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Hospital | 35233 | Birmingham | Alabama |
| UCSF | 94143 | San Francisco | California |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| Mass General Brigham | 02114 | Boston | Massachusetts |
| Tisch Cancer Institute at Mount Sinai | 10029 | New York | New York |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| Atrium Health Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Penn Medicine | 19104 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| The Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
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