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NCT07116616
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Conditions: Relapsed or Refractory Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 190
Sponsor: ModernaTX, Inc.
Location: University of Alabama at Birmingham Hospital Birmingham Alabama
Summary
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
Key Inclusion Criteria:
* RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
* 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.
Source: ClinicalTrials.gov (NCT07116616). StuddyBuddy aggregates publicly available trial information.