drugset / Trial / NCT00545519
A Phase I Study Of Thymoglobulin In Patients With Relapsed Or Refractory Multiple Myeloma
Phase 1
Completed
6 enrolled
Washington University School of Medicine
Genzyme, a Sanofi Company · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To determine the maximum tolerated dose and dose limiting toxicity of thymoglobulin in multiple myeloma patients. To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with Thymoglobulin. To determine the time to response, duration of response, and time to progression and overall survival of patients treated with Thymoglobulin. To determine the safety and tolerability of Thymoglobulin in these patients. To assess the changes in lymphocyte apoptosis and apoptotic signaling in treated patients.
Timeline
- Start
- 2006-10
- Primary completion
- 2008-03
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymoglobulin | Protein / enzyme biologic | 2 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 3 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 4 mg/kg | — |