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.
18 Years
N/A
Both
Myelodysplastic Syndromes, Thrombocytopenia
Trial Information
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.
Inclusion Criteria:
- Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO)
classification
- Low or Intermediate-1 risk category MDS using the IPSS
- Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each
cycle for at least 4 cycles
- Eastern Cooperative Oncology (ECOG) performance status of 0-2
- Subjects must be at least 18 years of age or older
Exclusion Criteria:
- Prior exposure to >3 cycles of lenalidomide
- Exposure to lenalidomide within the last 30 days
- Prior history of leukemia or aplastic anemia
- Prior history of stem cell 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
years before randomization
- Active or uncontrolled infections
- Unstable angina, congestive heart failure [NYHA > 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 in the past year
- Received IL-11 within 4 weeks of screening
- Less than 4 weeks since receipt of any investigational drug or device
- Have previously received any other thrombopoietic growth factor
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive
precautions, in the judgment of the investigator
- Known hypersensitivity to any recombinant E coli-derived product
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 one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.
Outcome Time Frame:
Treatment period through interim follow-up visit (up to 16 weeks)
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20060102
NCT ID:
NCT00418665
Start Date:
December 2006
Completion Date:
October 2010
Related Keywords:
- Myelodysplastic Syndromes
- Thrombocytopenia
- Revlimid
- Lenalidomide
- Low Platelet Count
- Low Risk Myelodysplastic Syndrome
- Intermediate 1 Myelodysplastic Syndrome
- MDS
- Myelodysplastic Syndrome
- Myelodysplastic Syndromes
- Preleukemia
- Thrombocytopenia
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