Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35%
had a partial response and 25% had stable disease. The combination of Velcade and
thalidomide has been studied in patients with multiple myeloma, but not in patients with
myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and
MTD of velcade with given in combination with thalidomide in patients with myelodysplasia.
Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1,
4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3
cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7,
1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will
start within 2 weeks of completion of the previous cycle. Disease response will be
evaluated after cycle 3 and 6.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
Karen Ballen, M
Massachusetts General Hospital, Harvard University
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|