drugset / Trial / NCT01242267
Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT
Phase 1/2
Completed
29 enrolled
Hackensack Meridian Health
Millennium Pharmaceuticals, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to: • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan The secondary objectives of this study are to: * Determine the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan * Determine the complete response (CR) and very good partial response (VgPR) rate in patients undergoing ASCT using thalidomide, bortezomib and melphalan * Evaluate the treatment-free interval after treatment with the combination of thalidomide, bortezomib and melphalan
Timeline
- Start
- 2010-05-11
- Primary completion
- 2016-01-20
- Completion
- 2016-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thalidomide | Other / unclassified | 600 mg | — |
| Subject | Thalidomide | Other / unclassified | 800 mg | — |
| Subject | Thalidomide | Other / unclassified | 1000 mg | — |
| Background | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 200 mg/m2 | Intravenous |