drugset / Trial / NCT04754945
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
Phase 1
Active not recruiting
11 enrolled
Emory University
National Cancer Institute (NCI) · collabSanofi · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis). Isatuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Timeline
- Start
- 2021-04-28
- Primary completion
- 2027-05-06
- Completion
- 2028-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Subcutaneous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 400 mg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 12 mg | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | — | Intravenous |