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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00418665
First received: January 4, 2007
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Thrombocytopenia
Biological: AMG 531
Drug: Placebo
Phase 2

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
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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Occurrence of a Clinically Significant Thrombocytopenic Event [ Time Frame: Treatment period through interim follow-up visit (up to 16 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia [ Time Frame: Treatment period (up to 16 weeks) ] [ Designated as safety issue: No ]
    Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia

  • 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 [ Time Frame: Treatment period and post-treatment follow-up (up to 21 weeks) ] [ Designated as safety issue: No ]
    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.

  • Platelet Transfusion [ Time Frame: Treatment period (up to 16 weeks) ] [ Designated as safety issue: No ]
    Occurrence of one or more platelet transfusions during the treatment period


Enrollment: 39
Study Start Date: December 2006
Study Completion Date: October 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 750 mcg AMG 531
750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
Placebo Comparator: Placebo Part B
Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)
Drug: Placebo
Subjects in the control group will receive placebo via subcutaneous injection.
Placebo Comparator: Placebo Part A
Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
Drug: Placebo
Subjects in the control group will receive placebo via subcutaneous injection.
Active Comparator: 500 mcg AMG 531
500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
Active Comparator: 750 mcg AMG531 Part B
750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418665

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00418665     History of Changes
Other Study ID Numbers: 20060102
Study First Received: January 4, 2007
Results First Received: November 24, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Revlimid
Lenalidomide
Low Platelet Count
Low Risk Myelodysplastic Syndrome
Intermediate 1 Myelodysplastic Syndrome
MDS
Myelodysplastic Syndrome

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Thrombocytopenia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Blood Platelet Disorders
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014