Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00321711
• Date of registration: 02/05/2006
• Primary sponsor: Amgen
• Public title: Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
• Scientific title: 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
• Date of first enrolment: October 2006
• Target sample size: 69
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00321711
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

MDS

Myelodysplastic Syndromes

Thrombocytopenia

Intervention(s)

Biological: AMG 531 (Romiplostim)

Drug: Azacitidine

Drug: Decitabine

Drug: Placebo

Primary Outcome(s)

Occurrence of a Clinically Significant Thrombocytopenic Event [Time Frame: Treatment period (up to 20 weeks)]

Secondary Outcome(s)

Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period [Time Frame: Treatment period (up to 20 weeks)]

Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia [Time Frame: Treatment period (up to 20 weeks)]

Platelet Transfusion [Time Frame: Study day 1 through the interim follow-up visit (up to 20 weeks)]

Secondary ID(s)

20050232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors