Trials / Completed
CompletedNCT00418665
A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMG 531 | AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg. |
| DRUG | Placebo | Subjects in the control group will receive placebo via subcutaneous injection. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2009-03-01
- Completion
- 2010-10-01
- First posted
- 2007-01-05
- Last updated
- 2011-01-24
- Results posted
- 2010-12-22
Source: ClinicalTrials.gov record NCT00418665. Inclusion in this directory is not an endorsement.