drugset / Trial / NCT00580242
A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia
Phase 1
Completed
23 enrolled
Massachusetts General Hospital
Celgene Corporation · collabDana-Farber Cancer Institute · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.
Timeline
- Start
- 2007-11
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 0.7 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |