drugset / Trial / NCT07828522
F182112 in Combination With Isatuximab and Lenalidomide for the Treatment of Patients With Newly Diagnosed Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-center, single-arm, exploratory pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of F182112 in combination with isatuximab and lenalidomide in transplant-eligible patients with newly diagnosed multiple myeloma. The study will also explore preliminary proof-of-concept signals of deep responses and minimal residual disease (MRD) negativity with this regimen, thereby informing the design of a subsequent phase II clinical trial.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2027-10-09
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | F182112 | Monoclonal antibody | 180 ug/kg | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |