The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
190
intravenous or subcutaneous
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGNumber 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
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 6 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
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Emory University Hospital
Atlanta, Georgia, United States
RECRUITINGMass General Brigham
Boston, Massachusetts, United States
RECRUITINGTisch Cancer Institute at Mount Sinai
New York, New York, United States
RECRUITINGMemorial Sloan-Kettering Cancer Center
New York, New York, United States
RECRUITINGAtrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGPenn Medicine
Philadelphia, Pennsylvania, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGThe Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGTime frame: Up to 1 year
Number of Participants with Antibodies to mRNA-2808 Components
Time frame: Up to 1 year