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A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents


Phase 2
18 Years
N/A
Not Enrolling
Both
MDS, Myelodysplastic Syndromes, Thrombocytopenia

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Trial Information

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Occurrence of a Clinically Significant Thrombocytopenic Event

Outcome Description:

Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.

Outcome Time Frame:

Treatment period (up to 20 weeks)

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20050232

NCT ID:

NCT00321711

Start Date:

October 2006

Completion Date:

October 2010

Related Keywords:

  • MDS
  • Myelodysplastic Syndromes
  • Thrombocytopenia
  • MDS
  • Myelodysplastic Syndromes
  • Refractory Cytopenias
  • Thrombocytopenia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Thrombocytopenia

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