A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

NCT00095264 | Completed Phase 2

• 1 other identifier: 20030207
• Study Type: interventional
• Target: 209
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects achieving an erythroid response during the 13-week test period

Secondary Outcomes (4)

• 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

Interventions

Darbepoetin Alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Gabrilove J, Paquette R, Lyons RM, Mushtaq C, Sekeres MA, Tomita D, Dreiling L. Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes. Br J Haematol. 2008 Jul;142(3):379-93. doi: 10.1111/j.1365-2141.2008.07181.x. Epub 2008 Jun 6.

  PMID: 18540943 RESULT

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2004
• First Posted: November 3, 2004
• Study Start: October 1, 2004
• Last Updated: January 15, 2010

Record last verified: 2010-01