A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

Myelodysplastic Syndromes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418665
• Other study ID #: 20060102
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: January 20, 2011
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: January 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome
• Thrombocytopenia
• Thrombocytosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a Clinically Significant Thrombocytopenic Event	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.	Treatment period through interim follow-up visit (up to 16 weeks)	No
Secondary	Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia	Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia	Treatment period (up to 16 weeks)	No
Secondary	Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines	CR = decrease in bone marrow blast (=5%) and improvement in peripheral blood counts (Hgb = 11 g/dL, platelets = 100x10^9/L, neutrophils = 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts =50% but not =5, or decrease in International Prognostic Scoring System score.	Treatment period and post-treatment follow-up (up to 21 weeks)	No
Secondary	Platelet Transfusion	Occurrence of one or more platelet transfusions during the treatment period	Treatment period (up to 16 weeks)	No

External Links

•   AmgenTrials clinical trials website