A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
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).
Arms & interventions
- DrugmRNA-2808
intravenous
Outcome measures
Primary
Number of Participants with Dose-limiting Toxicity
Time frame: Up to 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 15 months
Secondary
Maximum Plasma Concentration (Cmax)
Time frame: Up to 1 year
Area Under the Concentration-time Curve (AUC)
Time frame: Up to 1 year
Maximum Effect/Concentration of the Expressed Protein (Emax)
Time frame: Up to 1 year
Area Under the Effect Concentration (AUEC)
Time frame: Up to 1 year
Overall Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Number of Participants with Minimal Residual Disease Negativity Status
Time frame: Up to 3 years
Number of Participants with Antibodies to mRNA-2808 Derived Proteins
Time frame: Up to 1 year
Number of Participants with Antibodies to mRNA-2808 Components
Time frame: Up to 1 year
Eligibility criteria
Study locations (10)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
UCSF
San Francisco, California, 94143
Emory University Hospital
Atlanta, Georgia, 30322
Mass General Brigham
Boston, Massachusetts, 02114
Tisch Cancer Institute at Mount Sinai
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
Penn Medicine
Philadelphia, Pennsylvania, 19104
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226