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A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia

Myelodysplasia Clinical Trial

Official title:
A Phase I Dose Escalating Study of Bortezomib and Lenalidomide in Patients With Untreated or Previously Treated, Primary and Secondary Non 5q- Del Myelodysplasia

Clinical Trial 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.

Clinical Trial Description

Currently, there are no curative therapies for myelodysplasia except for allogeneic stem cell transplantation. Both lenalidomide and bortezomib have activity as single agents in patients with myelodysplasia. 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 withlenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle. The planned bortezomib doses have been evaluated in previous Phase I clinical studies in similar patient populations and have been safe and well tolerated in a twice-weekly schedule of administration. Lenalidomide has been shown to have efficacy in myelodysplasia. The combination of lenalidomide and bortezomib has been used in patients with multiple myeloma. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00580242
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase Phase 1
Start date November 2007
Completion date March 2012
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