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
More Details
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.