A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModernaTX, Inc.
About this trial
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
Qualifiers
RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- mRNA-2808
Treatment groups
166 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov