myelodysplasia myelodysplastic syndroom
Conditions
Interventions
Treatment with escalating dosages of VELCADE in combination with ZARNESTRA in 4
to 6 cycles of 4 weeks.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: MDS (including the non-proliferative form of CMML, i.e. CMML with a WBC count
Exclusion criteria
Exclusion criteria: IPSS score: low risk and intermediate-1 category. Candidates for allogeneic stem cell transplantation. Clinical relevant liver (AST/ALT equal to or higer than 1,5 ULN and bilirubin equal to or higher than 2 mg/dl) or renal insufficiency (ECC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (type, frequency, and severity [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0] of adverse events, and relationship of adverse events to VELCADE in combination with ZARNESTRA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Effectivity in terms of hematologic improvement, number of patients with a complete or partial response of stable disease, number of patients with a cytogenetic response (all defined according to revised International Working Group Criteria) 2) Effects of bortezomib and tipifarnib on ubiquitine and proteasome pathways and apoptotic gene expression profiles (translational research) | — |
Countries
Netherlands
Outcome results
None listed