NCT07116616RecruitingPhase 1/2
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 17 Jun 2030
- Lead sponsor
- ModernaTX, Inc.
- Diseases
- Multiple myeloma
- NCT number
- NCT07116616
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 190
- From 30 Sept 2025 to the primary completion date, 17 Jun 2030
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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%.
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Alabama At Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Mass General Brigham Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Atrium Health Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| The Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Tisch Cancer Institute at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Penn Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.