Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT
Status:
Completed
Trial end date:
2016-01-20
Target enrollment:
Participant gender:
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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Hackensack Meridian Health Hackensack University Medical Center