A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Purpose
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Condition
- Relapsed or Refractory Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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%
Exclusion Criteria
- 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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental mRNA-2808 |
Participants will receive mRNA-2808. |
|
Recruiting Locations
University of Alabama at Birmingham Hospital
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Tisch Cancer Institute at Mount Sinai
New York, New York 10029
New York, New York 10029
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.