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

NCT00418665 | Completed Phase 2 Results

• 1 other identifier: 20060102
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myelodysplastic Syndromes; Thrombocytopenia

Keywords

Revlimid; Lenalidomide; Low Platelet Count; Low Risk Myelodysplastic Syndrome; Intermediate 1 Myelodysplastic Syndrome; MDS; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia

  Treatment period (up to 16 weeks)

• 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

  Treatment period and post-treatment follow-up (up to 21 weeks)

• Platelet Transfusion

  Treatment period (up to 16 weeks)

Study Arms (5)

750 mcg AMG 531

ACTIVE COMPARATOR

750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Biological: AMG 531

Placebo Part B

PLACEBO COMPARATOR

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Drug: Placebo

Placebo Part A

PLACEBO COMPARATOR

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Drug: Placebo

500 mcg AMG 531

ACTIVE COMPARATOR

500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Biological: AMG 531

750 mcg AMG531 Part B

ACTIVE COMPARATOR

750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Biological: AMG 531

Interventions

AMG 531 BIOLOGICAL

AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.

500 mcg AMG 531; 750 mcg AMG 531; 750 mcg AMG531 Part B

Placebo DRUG

Subjects in the control group will receive placebo via subcutaneous injection.

Placebo Part A; Placebo Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Wang ES, Lyons RM, Larson RA, Gandhi S, Liu D, Matei C, Scott B, Hu K, Yang AS. A randomized, double-blind, placebo-controlled phase 2 study evaluating the efficacy and safety of romiplostim treatment of patients with low or intermediate-1 risk myelodysplastic syndrome receiving lenalidomide. J Hematol Oncol. 2012 Nov 29;5:71. doi: 10.1186/1756-8722-5-71.

  PMID: 23190430 DERIVED

Related Links

• Notice regarding posted summaries of trial results
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Myelodysplastic Syndromes; Thrombocytopenia

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 5, 2007
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2010
• Last Updated: January 24, 2011
• Results First Posted: December 22, 2010

Record last verified: 2011-01