Myelodysplastic Syndromes
Conditions
Keywords
Myelodysplastic Syndrome
Brief summary
The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).
Interventions
DRUGDarbepoetin Alfa
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving an erythroid response during the 13-week test period | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving an erythroid response during the 28-week treatment period | — |
| The change in Hb from baseline | — |
| The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit) | — |
| The change in FACT-F from baseline | — |
Outcome results
None listed