A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: ModernaTX, Inc.
ClinicalTrials ID:NCT07116616
This study assesses the safety and tolerability of intravenous mRNA-2808 in participants with relapsed or refractory multiple myeloma. Eligible participants must have prior exposure to a proteasome inhibitor, an IMiD, and a CD38 monoclonal antibody, with measurable disease criteria such as specific M-protein levels, FLC levels, plasmacytoma size, or bone marrow plasma cell percentage.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Eligibility Criteria
Inclusion Criteria
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RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
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Measurable disease defined as at least 1 of the following:
- Serum M-protein ≥0.5 grams/deciliter
- Urine M-protein ≥200 milligrams (mg)/24-hour
- Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio
- Plasmacytoma with a single diameter ≥2 centimeters
- Bone marrow plasma cells >30%
Key
Exclusion Criteria
- Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
- Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.
- Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.
- Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).
- Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).
- Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).
- Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).
- Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).
- Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).
Note: Other inclusion and exclusion criteria may apply.
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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