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Study Complete
Sponsor ID
20050232

Determination of Safe and Effective Dose of Romiplostim (AMG 531) in subjects with Myelodysplastic Syndrome (MDS)receiving Hypomethylating Agents

Sponsor ID
20050232
Clinicaltrials.gov ID
NCT00321711
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.

Additional Study Details

Phase
Phase 2
Product
romiplostim
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
69
Additional Study Details

Protocol Summary

Primary Outcome Measures

Occurrence of a Clinically Significant Thrombocytopenic Event

Timeframe: Treatment period (up to 20 weeks)

Secondary Outcome Measures

Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia

Timeframe: Treatment period (up to 20 weeks)

Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period

Timeframe: Treatment period (up to 20 weeks)

Platelet Transfusion

Timeframe: Study day 1 through the interim follow-up visit (up to 20 weeks)

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Blood Cancer (Other)
    • Show more
  • Myelodysplastic Syndrome
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Oct 2006 - Oct 2009
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles
    Exclusion Criteria:
    • Prior exposure to >3 cycles hypomethylating agents • Prior history of leukemia or aplastic anemia • Prior history of bone marrow transplantation • Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization • Active or uncontrolled infections • Unstable angina, congestive heart failure [NYHA (New York Heart Association) > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction • History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year • History of venous thrombosis that currently requires anti-coagulation therapy • Received IL-11 within 4 weeks of screening • Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication • Have previously received any other thrombopoietic growth factor