A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

Korábbi kezelés

• 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.

Egyéb

• 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%.

• 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%