Clinical trial · Interventional
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
NCT07116616CI-TRIAL-00119219recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mRNA-2808 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mRNA-2808
- description
- Participants will receive mRNA-2808.
- interventionNames
- Drug: mRNA-2808
Primary outcomes (2)
- measure
- Number of Participants with Dose-limiting Toxicity
- timeFrame
- Up to 28 days
- measure
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to 15 months
Secondary outcomes (11)
- measure
- Maximum Plasma Concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key 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% Key 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.
References
Publications (0)
Data not yet available
No reference posted for this study.