NCT00580242

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myelodysplasia

Interventions

Type	Name	Description
DRUG	Bortezomib	First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
DRUG	Bortezomib	Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
DRUG	Bortezomib	Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
DRUG	Lenalidomide	Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2007-12-24
• Last updated: 2012-03-08

Locations

2 sites across 1 country: United States