drugset / Trial / NCT06455748
Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-01-01
- Completion
- 2025-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Subcutaneous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Subject | Pomalidomide | Other / unclassified | 2 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |