A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Drug: mRNA-2808
- Registration Number
- NCT07116616
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 166
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mRNA-2808 mRNA-2808 Participants will receive mRNA-2808.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose-limiting Toxicity Up to 28 days Number of Participants with Treatment-emergent Adverse Events (TEAEs) Up to 15 months
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) Up to 1 year Area Under the Concentration-time Curve (AUC) Up to 1 year Maximum Effect/Concentration of the Expressed Protein (Emax) Up to 1 year Area Under the Effect Concentration (AUEC) Up to 1 year Overall Response Rate (ORR) Up to 3 years Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria Up to 3 years Overall Survival (OS) Up to 3 years Number of Participants with Minimal Residual Disease Negativity Status Up to 3 years Duration of Response (DOR) Up to 3 years Number of Participants with Antibodies to mRNA-2808 Derived Proteins Up to 1 year Number of Participants with Antibodies to mRNA-2808 Components Up to 1 year
Trial Locations
- Locations (10)
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
UCSF
🇺🇸San Francisco, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Mass General Brigham
🇺🇸Boston, Massachusetts, United States
Tisch Cancer Institute at Mount Sinai
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Atrium Health Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Alabama at Birmingham Hospital🇺🇸Birmingham, Alabama, United States